Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer (INTERACT)
Primary Purpose
Pediatric Cancer, Leukemia, Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Integrative neuromuscular training (INT)
Active control group: home-based training program
motivational counseling session
Sponsored by
About this trial
This is an interventional prevention trial for Pediatric Cancer focused on measuring Pediatric Exercise Oncology, Integrative Neuromuscular Training, Children and Adolescents, ResistanceTraining, Metabolic Syndrome, Physical Activity, Motivation
Eligibility Criteria
Inclusion Criteria:
- All malign and benign disorders treated with chemotherapy and/or irradiation
Exclusion Criteria:
- Severe mental and/or physical disability, i.e. participants where all types of physical training and testing of physical function are contraindicated
- terminal illness
- unable to communicate in Danish
Sites / Locations
- Aarhus University Hospital
- RigshospitaletRecruiting
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Integrative neuromuscular training + motivational counseling + usual care
Active control group + motivational counseling + usual care
Arm Description
General and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility.
home-based training program
Outcomes
Primary Outcome Measures
Lower extremity isometric knee extension strength
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Lower extremity isometric knee extension strength
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Secondary Outcome Measures
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Blood pressure (mmHg) will be measured in the morning and in the right arm with the subject in the sitting position. TMarkers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol(primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3.
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Isometric Bench Press
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Isometric Bench Press
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Isometric Bench Press
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Isometric Bench Press
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Isometric Bench Press
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Hand Grip strength
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Hand Grip strength
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Hand Grip strength
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Hand Grip strength
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Hand Grip strength
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Six Minutes Walk Test
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Six Minutes Walk Test
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Six Minutes Walk Test
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Six Minutes Walk Test
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Six Minutes Walk Test
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Thirty Seconds and One-Minute Sit-to-stand
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Thirty Seconds and One-Minute Sit-to-stand
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Thirty Seconds and One-Minute Sit-to-stand
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
The timed Up-and-Go Test:
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Thirty Seconds and One-Minute Sit-to-stand
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Thirty Seconds and One-Minute Sit-to-stand
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
The timed Up-and-Go Test:
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
The timed Up-and-Go Test:
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
The timed Up-and-Go Test:
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
The timed Up-and-Go Test:
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Hospitalized days
Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records
Hospitalized days
Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records
Hospitalized days
Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records
Body composition: Bone Mineral Density
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Bone Mineral Content
Bone Mineral content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Body Fat
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Fat-Free Mass
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Bone Mineral Density
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Bone Mineral Content
Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Body Fat
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Fat-Free Mass
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Bone Mineral Density
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Bone Mineral Content
Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Body Fat
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Fat-Free Mass
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Bone Mineral Density
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Bone Mineral Content
Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Body Fat
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Body composition: Fat-Free Mass
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
Prevalence of metabolic syndrome
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Prevalence of metabolic syndrome
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Prevalence of metabolic syndrome
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Prevalence of metabolic syndrome
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Full Information
NCT ID
NCT04706676
First Posted
January 5, 2021
Last Updated
June 6, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital, Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04706676
Brief Title
Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer
Acronym
INTERACT
Official Title
Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer- a Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital, Odense University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The INTERACT study is a nation-wide, population-based randomized controlled trial to investigate the effects of 6-month integrative neuromuscular training during anti-cancer treatment on lower body muscle strength, metabolic syndrome, various measures of physical function, physical activity, days of hospitalization, health-related quality of life and health behavior in children and adolescents with cancer. The increased insight derived from this study will impact the development of pediatric exercise oncology and be of high relevance to a broad group of children and adolescents with severe chronic illness.
The study is based on the overarching hypothesis, that structured integrative neuromuscular training initiated immediately after diagnosis will be effective in preventing deficits in neuromuscular function, limit long-term cardio-metabolic morbidity and found long-standing improvements in physical activity behavior.
To maintain adherence and motivation throughout a 6-month training intervention, weekly supervision of the training is needed. For this study, it is hypothesized that a supervised exercise intervention, in addition to a motivational counseling intervention and usual care, will improve muscle strength compared with unsupervised home-based training (active controls).
Detailed Description
Improved childhood cancer survival rates call for novel strategies to reduce acute and long-term physical complications of anti-cancer treatment.
Children with cancer have markedly impaired muscle strength, cardiorespiratory fitness, and physical function occurring few days after diagnosis - further declining because of anti-cancer treatment and physical inactivity during the treatment trajectory. Moreover, these impairments persist years after ended treatment. Further, the children become physically illiterate, which include a lack of confidence, competence and motivation to engage in physical activities. The combination of persistent physical complications and physical illiteracy predispose for metabolic- as well as musculoskeletal dysfunction that lead to severe medical conditions such as metabolic syndrome, diabetes and cardiovascular disease with reduced life-expectancy.
Studies indicate that structured exercise aimed to optimize both muscle and neuronal functions ('integrative neuromuscular training'), should be explored further to effectively counteract the impairment in physical function caused by childhood cancer and its treatment and found a more healthy lifestyle after ended treatment. This age-adjusted, strength-based exercise concept, based on games and play, is hypothesized to improve physical function in children and adolescents diagnosed with cancer.
The primary objective of this study is to investigate the effects of a 6-months integrative neuromuscular training intervention on knee extension strength in children and adolescents, ages 6-18 years, with cancer during anti-cancer treatment, compared with an active control group. Our secondary objectives are to investigate the effects of the intervention on markers of metabolic syndrome, hospitalized days, health-related quality of life, upper body muscle strength, cardiorespiratory fitness, physical function, physical activity behavior and body composition.
All outcomes, except hospitalized days, will be measured within 2 weeks of treatment initiation, 3-months after inclusion, after 6-months after inclusion, one month after ended treatment and 1 year after ended treatment.
The primary endpoint for the primary objective and secondary objectives, besides metabolic syndrome, are 6 months after treatment initiation. The primary endpoint for markers of metabolic syndrome will be 1 year after cessation of treatment
The INTERACT study is a national multicenter, two arm parallel group, randomized controlled superiority trial with 12 months follow-up after ended treatment, based in all national centers for pediatric oncology: University Hospital of Copenhagen (Rigshospitalet), Aarhus University Hospital and Odense University Hospital.
The study will include 127 children aged 6-18 years with any type of cancer that will be randomized (2:2) to either the intervention group (integrative neuromuscular training + motivational-counseling sessions + usual care) or active control group (home-based training program + motivational-counseling sessions + usual care) and stratified by sex, pubertal stage and diagnosis as 1) treatment for extracranial solid tumors and CNS-tumors; 2) treatment for hematologic malignancy 3) stem cell transplantation, within each hospital.
This intervention, integrative neuromuscular training (INT), contains a multifaceted range of developmentally appropriate activities that incorporate general and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility. INT can be camouflaged as games and play or performed as structured strength and conditioning program, depending on the participant's age, motor skill level and diagnosis. The intervention is designed to enhance health- and skill-related components of physical fitness.
The integrative neuromuscular training group will in addition to usual care receive the intervention for six months.
All participants are recommended to participate in a minimum of 2 training session per week the first 7 weeks, and a minimum of three session per week from week 8-24. During the intense phase of treatment (first six months of treatment), all participants indifferent of cancer type will receive combinations of treatment requiring either hospitalization or visits to the outpatient clinic at least once per week. The participants, therefore, receives supervised training at least once per week. All other training session is conducted as home-based training. If there are weeks, without any visits to the hospital or outpatient clinic, all training session will be conducted at home. In this case, the participants will receive a phone call from the intervention physiotherapist concerning questions, exercise choice and intensity of exercises.
Parents or guardians will receive education in conducting INT at home, alongside an exercise-kit consisting of training equipment corresponding to the child's age and fitness level (fitness ropes, medicine ball, dumbbells).
The active control group is, in addition to usual care, offered a home-based training program consisting of combined aerobic, strength and stretching exercises.
Participants in both groups will receive a monthly 30-minute motivational-counseling session to adjust the intervention and training program according to the child's physical capacity and preferences. Further, the session will determine potential barriers towards performing physical exercise using the Self-efficacy for Exercise Scale.
Both groups receive standardized hospital care, usual care, including physiotherapy if needed
Sample size:
A difference of 10 % as a result of physical exercise is regarded as a clinically relevant change (1). Based on a mean 41.4 +/- 7.6 (2) and a 10% increase, an alpha level of 0.05 and power of 80%, 106 children are needed. Approximately, 60 children with cancer at the age of 6-18 years will be diagnosed pr. year at Copenhagen University Hospital, Rigshospitalet Aarhus University Hospital and Odense University Hospital. Assuming a 20 % dropout rate, a total of 2.2 years is needed to include the required number of children with cancer (n=127).
A blinded statistician will randomize participants to either intervention or active control group using a computer-generated concealed allocation procedure, to secure a proportionate stratified random sample.
Due to the nature of the intervention, neither participants, nor assessors, will be blinded to the allocation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cancer, Leukemia, Neoplasms, Lymphoma, Solid Tumor, CNS Tumor
Keywords
Pediatric Exercise Oncology, Integrative Neuromuscular Training, Children and Adolescents, ResistanceTraining, Metabolic Syndrome, Physical Activity, Motivation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Integrative neuromuscular training + motivational counseling + usual care
Arm Type
Experimental
Arm Description
General and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility.
Arm Title
Active control group + motivational counseling + usual care
Arm Type
Active Comparator
Arm Description
home-based training program
Intervention Type
Behavioral
Intervention Name(s)
Integrative neuromuscular training (INT)
Intervention Description
Integrative neuromuscular training (INT), contains a multifaceted range of developmentally appropriate activities that incorporate general and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility. INT can be camouflaged as games and play or performed as structured strength and conditioning program, depending on the participant's age, motor skill level and diagnosis. The intervention is designed to enhance health- and skill-related components of physical fitness.
Parents or guardians will receive education in conducting INT at home, alongside an exercise-kit consisting of training equipment corresponding to the child's age and fitness level (fitness ropes, medicine ball, dumbbells).
The INT group will receive usual standardized hospital care, including physiotherapy if needed.
Intervention Type
Behavioral
Intervention Name(s)
Active control group: home-based training program
Intervention Description
The active control group is offered a home-based training program consisting of combined aerobic, strength and stretching exercises. Further, they will receive monthly motivational consultations, as described below, concerning the training program. The use of the home-based training program will be monitored through exercise journals.
The INT group will receive usual standardized hospital care, including physiotherapy if needed.
Intervention Type
Behavioral
Intervention Name(s)
motivational counseling session
Intervention Description
Each child and their parents will participate in a monthly 30-minute motivational counseling session to adjust the intervention and training program according to the child's physical capacity and preferences. Further, the session will determine potential barriers towards performing physical exercise using the Self-efficacy for Exercise Scale.
The sessions are based on the principles in Self-Determination Theory that includes a spectrum of external and internal motivation factors for engaging in exercise. Each session will provide guidelines to increase the general activity levels and adjust the intervention according to the child's preferences and presence of symptoms.
Primary Outcome Measure Information:
Title
Lower extremity isometric knee extension strength
Description
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Time Frame
Within 2 weeks of treatment initiation (baseline)
Title
Lower extremity isometric knee extension strength
Description
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Time Frame
3-months after inclusion
Title
Lower extremity isometric knee extension strength
Description
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Time Frame
6-months after inclusion (primary endpoint)
Title
Lower extremity isometric knee extension strength
Description
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Time Frame
1 month after ended treatment
Title
Lower extremity isometric knee extension strength
Description
Isometric leg extension is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant is instructed to kick (forward) with maximal force keeping maximal intensity for at least five seconds. Three attempts with a two minutes break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. Highest score is noted.
The participant is sitting upright with hands grasping the bench. Hips and knees are kept in 90 degrees flexion. The height of the bench is adjusted to maintain both feet of the ground.
The chain to the dynamometer is adjusted in order to keep the leg in 90 degrees flexion during muscle contraction. The test is performed unilaterally, and in some cases solely on one leg as children with solid tumors in under extremities may be restricted to testing.
Time Frame
1 year after ended treatment
Secondary Outcome Measure Information:
Title
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Description
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
within 2 weeks of treatment initiation
Title
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
within 2 weeks of treatment initiation
Title
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
within 2 weeks of treatment initiation
Title
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Description
Blood pressure (mmHg) will be measured in the morning and in the right arm with the subject in the sitting position. TMarkers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
within 2 weeks of treatment initiation
Title
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
within 2 weeks of treatment initiation
Title
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Description
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
6 months after inclusion (before a treatment block)
Title
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
6 months after inclusion (before a treatment block)
Title
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
6 months after inclusion (before a treatment block)
Title
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
6 months after inclusion (before a treatment block)
Title
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
6 months after inclusion (before a treatment block)
Title
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Description
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
1 month after ended treatment
Title
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
1 month after ended treatment
Title
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol(primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
1 month after ended treatment
Title
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
1 month after ended treatment
Title
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
1 month after ended treatment
Title
Markers of metabolic syndrome: Waist circumference (primary secondary outcome)
Description
Waist circumference is measured in CM, at the end of several consecutive natural breaths, at a level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3.
Time Frame
1 year after end of treatment (primary endpoint)
Title
Markers of metabolic syndrome: triglycerides (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
1 year after end of treatment (primary endpoint)
Title
Markers of metabolic syndrome: high-density lipoprotein (HDL) cholesterol (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
1 year after end of treatment (primary endpoint)
Title
Markers of metabolic syndrome: blood pressure (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
1 year after end of treatment (primary endpoint)
Title
Markers of metabolic syndrome: fasting blood sugar and insulin (primary secondary outcome)
Description
Blood samples will be drawn from an antecubital vein, or when possible, through a central or peripheral venous catheter. Markers of Metabolic Syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
1 year after end of treatment (primary endpoint)
Title
Isometric Bench Press
Description
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Time Frame
Within 2 weeks of treatment initiation (baseline)
Title
Isometric Bench Press
Description
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Time Frame
3-months after inclusion
Title
Isometric Bench Press
Description
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Time Frame
6-months after inclusion (primary endpoint)
Title
Isometric Bench Press
Description
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Time Frame
1 month after ended treatment
Title
Isometric Bench Press
Description
Isometric bench press is tested using a special-build strength ergometer (Gym 2000®) with a dynamometer (US2A100 kg, Holtinger, Germany).
The participant lies in supine position, with shoulder in 150% of biacromial width and elbows in 90 degrees flexion, with the height of the bar adjusted accordingly. The participant is obliged to maintain this position during the test. The participant is instructed to push (upwards) with maximal force.
Time Frame
1 year after ended treatment
Title
Hand Grip strength
Description
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Time Frame
Within 2 weeks of treatment initiation (baseline)
Title
Hand Grip strength
Description
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Time Frame
3-months after inclusion
Title
Hand Grip strength
Description
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Time Frame
6-months after inclusion (primary endpoint)
Title
Hand Grip strength
Description
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Time Frame
1 month after ended treatment
Title
Hand Grip strength
Description
Handgrip strength is measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as test score. Hand Grip strength is also used as a surrogate measure for upper-body physical function.
Time Frame
1 year after ended treatment
Title
Six Minutes Walk Test
Description
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Time Frame
Within 2 weeks of treatment initiation (baseline)
Title
Six Minutes Walk Test
Description
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Time Frame
3-months after inclusion
Title
Six Minutes Walk Test
Description
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Time Frame
6-months after inclusion (primary endpoint)
Title
Six Minutes Walk Test
Description
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Time Frame
1 month after ended treatment
Title
Six Minutes Walk Test
Description
Maximal walking distance in six minutes, as a surrogate measure for cardiorespiratory fitness, is measured through the self-paced 6-minute walk test. Two cones are positioned on a straight course spaced at 20 m. The object of the test is to walk as far as possible in 6 minutes. Participants must walk back and forth around the cones, permitted to slow down, to stop, and to rest as necessary without running or jogging. The accumulated distance is noted, and degree of perceived exhaustion is estimated using the Borg Category-Ratio 1-10 Scale.
Time Frame
1 year after ended treatment
Title
Thirty Seconds and One-Minute Sit-to-stand
Description
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Time Frame
Within 2 weeks of treatment initiation (baseline)
Title
Thirty Seconds and One-Minute Sit-to-stand
Description
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Time Frame
3-months after inclusion
Title
Thirty Seconds and One-Minute Sit-to-stand
Description
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Time Frame
6-months after inclusion (primary endpoint)
Title
The timed Up-and-Go Test:
Description
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Time Frame
3-months after inclusion
Title
Thirty Seconds and One-Minute Sit-to-stand
Description
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Time Frame
1 month after ended treatment
Title
Thirty Seconds and One-Minute Sit-to-stand
Description
Sit-To-Stand is performed using a chair that allows the child to flex the legs at a 90o angle. The child is instructed to fold his/her arms across the chest or to let them hang to the side, stand straight and then touch the chair with their bottom while returning to a seated position. Strong verbal encouragement will be given during the test. Subjects were permitted to use rest periods to complete the one-minute period. The test score equates the number of repetitions during a 60 second period. As a marker for lower extremity muscle strength, the number repetition completed after 30 seconds will be noted.
Time Frame
1 year after ended treatment
Title
The timed Up-and-Go Test:
Description
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Time Frame
Within 2 weeks of treatment initiation (baseline)
Title
The timed Up-and-Go Test:
Description
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Time Frame
6-months after inclusion (primary endpoint)
Title
The timed Up-and-Go Test:
Description
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Time Frame
1 month after ended treatment
Title
The timed Up-and-Go Test:
Description
The timed Up-and-Go test (TUG) tests basic mobility, defined as the ability to get in and out of bed, to get up and down from a chair, to walk short distances, and to turn.
The test is performed using a chair that allows the child to flex the legs at a 90o angle. From the start position, with the back resting against the chair and arms on knees, the child is instructed to stand up, walk three meters as fast as possible, turn around and return to the start position. Completion time will be recorded in seconds to the nearest two decimals. Strong verbal encouragement will be given during the test. The lowest score of three tries will be used in the analysis.
Time Frame
1 year after ended treatment
Title
Hospitalized days
Description
Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records
Time Frame
measured 6 months after inclusion (primary endpoint)
Title
Hospitalized days
Description
Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records
Time Frame
1month after ended treatment
Title
Hospitalized days
Description
Number of admissions to hospital (total number of admissions, scheduled and unscheduled admission) will be drawn from the participants medical records
Time Frame
1 year after ended treatment
Title
Body composition: Bone Mineral Density
Description
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
within 2 weeks of treatment initiation
Title
Body composition: Bone Mineral Content
Description
Bone Mineral content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
within 2 weeks of treatment initiation
Title
Body composition: Body Fat
Description
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
within 2 weeks of treatment initiation
Title
Body composition: Fat-Free Mass
Description
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
within 2 weeks of treatment initiation
Title
Body composition: Bone Mineral Density
Description
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
6 months after inclusion (before a treatment block)
Title
Body composition: Bone Mineral Content
Description
Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
6 months after inclusion (before a treatment block)
Title
Body composition: Body Fat
Description
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
6 months after inclusion (before a treatment block)
Title
Body composition: Fat-Free Mass
Description
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
6 months after inclusion (before a treatment block)
Title
Body composition: Bone Mineral Density
Description
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
1 month after ended treatment.
Title
Body composition: Bone Mineral Content
Description
Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
1 month after ended treatment.
Title
Body composition: Body Fat
Description
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
1 month after ended treatment.
Title
Body composition: Fat-Free Mass
Description
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
1 month after ended treatment.
Title
Body composition: Bone Mineral Density
Description
Bone Mineral Density (g/cm2) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
1 year after end of treatment (primary endpoint).
Title
Body composition: Bone Mineral Content
Description
Bone Mineral Content (kg) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
1 year after end of treatment (primary endpoint).
Title
Body composition: Body Fat
Description
Body Fat (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
1 year after end of treatment (primary endpoint).
Title
Body composition: Fat-Free Mass
Description
Fat-Free Mass (kg and %) will be analyzed by whole-body DXA scan (DPX-IQ) (Lunar, Lunar Corporation Madison, WI, USA). Transverse scans at 1 cm intervals are made from head to toe measuring the absorption of x-ray beams at two different energy levels as these are sent through the body.
Time Frame
1 year after end of treatment (primary endpoint).
Title
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
Description
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
Time Frame
Within 2 weeks of treatment initiation
Title
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
Description
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
Time Frame
6-months after inclusion.
Title
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
Description
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
Time Frame
1 month after ended treatment
Title
The PedsQL Generic Core Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report:
Description
The Pediatric Quality of Life Inventory (PedsQL Core) measures the quality of life in children using 23 items on a five-point response scale from never to almost always. The answers are divided into four domains: health and physical activity, emotions, dealing with others, and school activity.
Time Frame
1 year after ended treatment
Title
Prevalence of metabolic syndrome
Description
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Time Frame
within 2 weeks of treatment initiation.
Title
Prevalence of metabolic syndrome
Description
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Time Frame
6 months after inclusion (before a treatment block)
Title
Prevalence of metabolic syndrome
Description
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Time Frame
1 month after ended treatment.
Title
Prevalence of metabolic syndrome
Description
Prevalence of Metabolic syndrome, based on markers described above (waist circumference, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, fasting blood sugar and insulin) will be calculated in the Intervention and active control group. Although Children between 6 and 9.9 years cannot be diagnosed with Metabolic syndrome, the potential decline or increase in the biological markers, i.e. predisposition, for metabolic syndrome will, however, be described in this study.
Time Frame
1 year after end of treatment (primary endpoint)
Other Pre-specified Outcome Measures:
Title
Metabolomics (explorative outcome)
Description
Metabolomics will be performed in urine and plasma for deep metabolomic phenotyping in collaboration with professor L.O. Dragsted (University of Copenhagen). The metabolites (<1500 Da) will be profiled by reversed-phase ultra-high-performance liquid chromatography coupled with a quadrupole - time-of-flight dual mass spectrometer.
Time Frame
within 2 weeks of treatment initiation, at 6 months (before a treatment block), one month after ended treatment and 1 year after end of treatment.
Title
Metabolomics (explorative outcome)
Description
Metabolomics will be performed in urine and plasma for deep metabolomic phenotyping in collaboration with professor L.O. Dragsted (University of Copenhagen). The metabolites (<1500 Da) will be profiled by reversed-phase ultra-high-performance liquid chromatography coupled with a quadrupole - time-of-flight dual mass spectrometer.
Time Frame
6 months after inclusion (before a treatment block.
Title
Metabolomics (explorative outcome)
Description
Metabolomics will be performed in urine and plasma for deep metabolomic phenotyping in collaboration with professor L.O. Dragsted (University of Copenhagen). The metabolites (<1500 Da) will be profiled by reversed-phase ultra-high-performance liquid chromatography coupled with a quadrupole - time-of-flight dual mass spectrometer.
Time Frame
1 month after ended treatment.
Title
Metabolomics (explorative outcome)
Description
Metabolomics will be performed in urine and plasma for deep metabolomic phenotyping in collaboration with professor L.O. Dragsted (University of Copenhagen). The metabolites (<1500 Da) will be profiled by reversed-phase ultra-high-performance liquid chromatography coupled with a quadrupole - time-of-flight dual mass spectrometer.
Time Frame
1 year after end of treatment.
Title
Dietary assessment (explorative outcome)
Description
Collection of information regarding the participants dietary intake is based on self-reporting during 3-5days in the online diet program 'Madlog' (Madlog Vita, Vitakost, Kolding Denmark). An overall report of intake calculated in both macro and micronutrients is determined based on the Danish Technical University's (DTU) and the Danish Food Institute's database FRIDA (Frida.com)
Time Frame
within 2 weeks of treatment initiation
Title
Dietary assessment (explorative outcome)
Description
Collection of information regarding the participants dietary intake is based on self-reporting during 3-5days in the online diet program 'Madlog' (Madlog Vita, Vitakost, Kolding Denmark). An overall report of intake calculated in both macro and micronutrients is determined based on the Danish Technical University's (DTU) and the Danish Food Institute's database FRIDA (Frida.com)
Time Frame
6 months after inclusion (before a treatment block),
Title
Dietary assessment (explorative outcome)
Description
Collection of information regarding the participants dietary intake is based on self-reporting during 3-5days in the online diet program 'Madlog' (Madlog Vita, Vitakost, Kolding Denmark). An overall report of intake calculated in both macro and micronutrients is determined based on the Danish Technical University's (DTU) and the Danish Food Institute's database FRIDA (Frida.com)
Time Frame
1 month after ended treatment.
Title
Dietary assessment (explorative outcome)
Description
Collection of information regarding the participants dietary intake is based on self-reporting during 3-5days in the online diet program 'Madlog' (Madlog Vita, Vitakost, Kolding Denmark). An overall report of intake calculated in both macro and micronutrients is determined based on the Danish Technical University's (DTU) and the Danish Food Institute's database FRIDA (Frida.com)
Time Frame
1 year after end of treatment.
Title
Intestinal microbiota (explorative outcome)
Description
Total DNA will be extracted from fecal samples using the Illumina HiSeq technology, generating16S data with the option to later run full microbiome sequencing on selected samples. These studies will be done in collaboration with the National Food Institute, Technical University of Denmark
Time Frame
within 2 weeks of treatment initiation, at 6 months (before a treatment block), one month after ended treatment and 1 year after end of treatment.
Title
Intestinal microbiota (explorative outcome)
Description
Total DNA will be extracted from fecal samples using the Illumina HiSeq technology, generating16S data with the option to later run full microbiome sequencing on selected samples. These studies will be done in collaboration with the National Food Institute, Technical University of Denmark
Time Frame
within 2 weeks of treatment initiation.
Title
Intestinal microbiota (explorative outcome)
Description
Total DNA will be extracted from fecal samples using the Illumina HiSeq technology, generating16S data with the option to later run full microbiome sequencing on selected samples. These studies will be done in collaboration with the National Food Institute, Technical University of Denmark
Time Frame
6 months after inclusion (before a treatment block.
Title
Intestinal microbiota (explorative outcome)
Description
Total DNA will be extracted from fecal samples using the Illumina HiSeq technology, generating16S data with the option to later run full microbiome sequencing on selected samples. These studies will be done in collaboration with the National Food Institute, Technical University of Denmark
Time Frame
1month after ended treatment.
Title
Intestinal microbiota (explorative outcome)
Description
Total DNA will be extracted from fecal samples using the Illumina HiSeq technology, generating16S data with the option to later run full microbiome sequencing on selected samples. These studies will be done in collaboration with the National Food Institute, Technical University of Denmark
Time Frame
1 year after end of treatment.
Title
Inflammatory cytokines and mediators (explorative outcome)
Description
Blood samples will be analyzed for inflammation-related growth factors, chemokines, incretins, epithelial and endothelial markers and cytokines including interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and macrophage-related biomarkers (sCD163 and sCD206), by ELISA or by the Luminex at the Institute of Inflammation Research, Copenhagen University Hospital, Rigshospitalet.
Time Frame
within 2 weeks of treatment initiation
Title
Inflammatory cytokines and mediators (explorative outcome)
Description
Blood samples will be analyzed for inflammation-related growth factors, chemokines, incretins, epithelial and endothelial markers and cytokines including interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and macrophage-related biomarkers (sCD163 and sCD206), by ELISA or by the Luminex at the Institute of Inflammation Research, Copenhagen University Hospital, Rigshospitalet.
Time Frame
6 months after inclusion (before a treatment block).
Title
Inflammatory cytokines and mediators (explorative outcome)
Description
Blood samples will be analyzed for inflammation-related growth factors, chemokines, incretins, epithelial and endothelial markers and cytokines including interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and macrophage-related biomarkers (sCD163 and sCD206), by ELISA or by the Luminex at the Institute of Inflammation Research, Copenhagen University Hospital, Rigshospitalet.
Time Frame
1 month after ended treatment.
Title
Inflammatory cytokines and mediators (explorative outcome)
Description
Blood samples will be analyzed for inflammation-related growth factors, chemokines, incretins, epithelial and endothelial markers and cytokines including interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and macrophage-related biomarkers (sCD163 and sCD206), by ELISA or by the Luminex at the Institute of Inflammation Research, Copenhagen University Hospital, Rigshospitalet.
Time Frame
1 year after end of treatment.
Title
Growth and Reproduction (explorative outcome)
Description
DNA purified from the blood samples will be analyzed for growth-factors gene polymorphism by PCR based technologies including insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3), testosterone (and tumor necrosis factor-alpha (TNF-α)) in collaboration with Department for Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet.
Time Frame
within 2 weeks of treatment initiation.
Title
Growth and Reproduction (explorative outcome)
Description
DNA purified from the blood samples will be analyzed for growth-factors gene polymorphism by PCR based technologies including insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3), testosterone (and tumor necrosis factor-alpha (TNF-α)) in collaboration with Department for Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet.
Time Frame
6 months after inclusion (before a treatment block)
Title
Growth and Reproduction (explorative outcome)
Description
DNA purified from the blood samples will be analyzed for growth-factors gene polymorphism by PCR based technologies including insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3), testosterone (and tumor necrosis factor-alpha (TNF-α)) in collaboration with Department for Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet.
Time Frame
1 month after ended treatment.
Title
Growth and Reproduction (explorative outcome)
Description
DNA purified from the blood samples will be analyzed for growth-factors gene polymorphism by PCR based technologies including insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3), testosterone (and tumor necrosis factor-alpha (TNF-α)) in collaboration with Department for Growth and Reproduction, Copenhagen University Hospital, Rigshospitalet.
Time Frame
1 year after end of treatment.
Title
Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome)
Description
All counter movement jumps are carried out on a mobile force plate platform (FP4, HUR-Labs Oy, Tampere, Finland). The participant is given instructions on how to perform the CMJ correctly and is given time to familiarize with each test.
The participant stands with both hands resting on the hips. Both hands must stay in this position during the test. The knee angle movement is standardized; participant is instructed to bend down until knees is in a 90-degree angle and immediately hereafter jumps a s high as possible in a vertical direction, landing on both feet simultaneously on the platform.
Three attempts with a one-minute break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. The highest score is noted.
Depending on tumor location, children with solid tumors may be restricted to participate in the counter movement jump.
Time Frame
Within 2 weeks of treatment initiation (baseline)
Title
Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome)
Description
All counter movement jumps are carried out on a mobile force plate platform (FP4, HUR-Labs Oy, Tampere, Finland). The participant is given instructions on how to perform the CMJ correctly and is given time to familiarize with each test.
The participant stands with both hands resting on the hips. Both hands must stay in this position during the test. The knee angle movement is standardized; participant is instructed to bend down until knees is in a 90-degree angle and immediately hereafter jumps a s high as possible in a vertical direction, landing on both feet simultaneously on the platform.
Three attempts with a one-minute break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. The highest score is noted.
Depending on tumor location, children with solid tumors may be restricted to participate in the counter movement jump.
Time Frame
6-months after inclusion
Title
Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome)
Description
All counter movement jumps are carried out on a mobile force plate platform (FP4, HUR-Labs Oy, Tampere, Finland). The participant is given instructions on how to perform the CMJ correctly and is given time to familiarize with each test.
The participant stands with both hands resting on the hips. Both hands must stay in this position during the test. The knee angle movement is standardized; participant is instructed to bend down until knees is in a 90-degree angle and immediately hereafter jumps a s high as possible in a vertical direction, landing on both feet simultaneously on the platform.
Three attempts with a one-minute break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. The highest score is noted.
Depending on tumor location, children with solid tumors may be restricted to participate in the counter movement jump.
Time Frame
3-months after inclusion
Title
Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome)
Description
All counter movement jumps are carried out on a mobile force plate platform (FP4, HUR-Labs Oy, Tampere, Finland). The participant is given instructions on how to perform the CMJ correctly and is given time to familiarize with each test.
The participant stands with both hands resting on the hips. Both hands must stay in this position during the test. The knee angle movement is standardized; participant is instructed to bend down until knees is in a 90-degree angle and immediately hereafter jumps a s high as possible in a vertical direction, landing on both feet simultaneously on the platform.
Three attempts with a one-minute break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. The highest score is noted.
Depending on tumor location, children with solid tumors may be restricted to participate in the counter movement jump.
Time Frame
1 month after ended treatment
Title
Muscle Power: Counter Movement Jump (Rate of Force Development)(explorative outcome)
Description
All counter movement jumps are carried out on a mobile force plate platform (FP4, HUR-Labs Oy, Tampere, Finland). The participant is given instructions on how to perform the CMJ correctly and is given time to familiarize with each test.
The participant stands with both hands resting on the hips. Both hands must stay in this position during the test. The knee angle movement is standardized; participant is instructed to bend down until knees is in a 90-degree angle and immediately hereafter jumps a s high as possible in a vertical direction, landing on both feet simultaneously on the platform.
Three attempts with a one-minute break is carried out, however the participant can try as many attempts as possible if the participant keeps showing improvements. The highest score is noted.
Depending on tumor location, children with solid tumors may be restricted to participate in the counter movement jump.
Time Frame
1 year after ended treatment
Title
Neuropathy - Ped-mTNS (explorative outcome)
Description
Neuropathy is evaluated using the Pediatric Modified Total Neuropathy Score (Ped-mTNS)(72). This validated instrument captures impairment-level information on the function of the peripheral nervous system and includes questions on sensory, motor, and autonomic symptoms; examination of light touch, pin, and vibration perception; muscle strength of distal musculature; and deep tendon reflexes.
Time Frame
Within 2 weeks of treatment initiation (baseline)
Title
Neuropathy - Ped-mTNS (explorative outcome)
Description
Neuropathy is evaluated using the Pediatric Modified Total Neuropathy Score (Ped-mTNS)(72). This validated instrument captures impairment-level information on the function of the peripheral nervous system and includes questions on sensory, motor, and autonomic symptoms; examination of light touch, pin, and vibration perception; muscle strength of distal musculature; and deep tendon reflexes.
Time Frame
3-months after inclusion
Title
Neuropathy - Ped-mTNS (explorative outcome)
Description
Neuropathy is evaluated using the Pediatric Modified Total Neuropathy Score (Ped-mTNS)(72). This validated instrument captures impairment-level information on the function of the peripheral nervous system and includes questions on sensory, motor, and autonomic symptoms; examination of light touch, pin, and vibration perception; muscle strength of distal musculature; and deep tendon reflexes.
Time Frame
6-months after inclusion
Title
Neuropathy - Ped-mTNS (explorative outcome)
Description
Neuropathy is evaluated using the Pediatric Modified Total Neuropathy Score (Ped-mTNS)(72). This validated instrument captures impairment-level information on the function of the peripheral nervous system and includes questions on sensory, motor, and autonomic symptoms; examination of light touch, pin, and vibration perception; muscle strength of distal musculature; and deep tendon reflexes.
Time Frame
one month after ended treatment
Title
Neuropathy - Ped-mTNS (explorative outcome)
Description
Neuropathy is evaluated using the Pediatric Modified Total Neuropathy Score (Ped-mTNS)(72). This validated instrument captures impairment-level information on the function of the peripheral nervous system and includes questions on sensory, motor, and autonomic symptoms; examination of light touch, pin, and vibration perception; muscle strength of distal musculature; and deep tendon reflexes.
Time Frame
1 year after ended treatment
Title
Physio- and occupational therapy treatments (explorative outcome)
Description
Total number physiotherapy and occupational therapy treaments (days) will be drawn from the participants medical records.
Time Frame
measured 6 months after inclusion
Title
Physio- and occupational therapy treatments (explorative outcome)
Description
Total number physiotherapy and occupational therapy treaments (days) will be drawn from the participants medical records.
Time Frame
1 month after ended treatment
Title
Physio- and occupational therapy treatments (explorative outcome)
Description
Total number physiotherapy and occupational therapy treaments (days) will be drawn from the participants medical records.
Time Frame
1 year after ended treatment
Title
General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report (explorative outcome)
Description
An validated questionnaire used in the UNGkan and HEIA project will be used to assess self-reported physical activity, physical function, sedentary time, screen time, diet habits, active transportation behavior, physical education participation, perceived barriers/facilitators to physical activity, health-related behaviors. The questionnaire contains four versions targeted either children (<14 years) or youth (>14 years) and the parents guardians to each of these subgroups. The questionnaire contains 35 items for the child/youth report and 18 items for the parent proxy report for both groups.
Time Frame
Within 2 weeks of treatment initiation.
Title
General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report: (explorative outcome)
Description
An validated questionnaire used in the UNGkan and HEIA project will be used to assess self-reported physical activity, physical function, sedentary time, screen time, diet habits, active transportation behavior, physical education participation, perceived barriers/facilitators to physical activity, health-related behaviors. The questionnaire contains four versions targeted either children (<14 years) or youth (>14 years) and the parents guardians to each of these subgroups. The questionnaire contains 35 items for the child/youth report and 18 items for the parent proxy report for both groups.
Time Frame
6-months after inclusion.
Title
General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report (explorative outcome)
Description
An validated questionnaire used in the UNGkan and HEIA project will be used to assess self-reported physical activity, physical function, sedentary time, screen time, diet habits, active transportation behavior, physical education participation, perceived barriers/facilitators to physical activity, health-related behaviors. The questionnaire contains four versions targeted either children (<14 years) or youth (>14 years) and the parents guardians to each of these subgroups. The questionnaire contains 35 items for the child/youth report and 18 items for the parent proxy report for both groups.
Time Frame
1 month after ended treatment.
Title
General Physical Acivity: Young Children (6-7 years), Children (8-12 years), Teens (13-18 years) Self-Report and Parent Proxy-Report (explorative outcome)
Description
An validated questionnaire used in the UNGkan and HEIA project will be used to assess self-reported physical activity, physical function, sedentary time, screen time, diet habits, active transportation behavior, physical education participation, perceived barriers/facilitators to physical activity, health-related behaviors. The questionnaire contains four versions targeted either children (<14 years) or youth (>14 years) and the parents guardians to each of these subgroups. The questionnaire contains 35 items for the child/youth report and 18 items for the parent proxy report for both groups.
Time Frame
1 year after ended treatment.
Title
The PedsQL 3.0 Cancer Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report
Description
The PedsQL 3.0 Cancer Module instrument encompasses eight subscales: (1) pain and hurt, (2) nausea, (3) procedural anxiety, (4) treatment anxiety, (5) worry, (6) cognitive problems, (7) perceived physical appearance, and (8) communication
Time Frame
Within 2 weeks of treatment initiation.
Title
The PedsQL 3.0 Cancer Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome)
Description
The PedsQL 3.0 Cancer Module instrument encompasses eight subscales: (1) pain and hurt, (2) nausea, (3) procedural anxiety, (4) treatment anxiety, (5) worry, (6) cognitive problems, (7) perceived physical appearance, and (8) communication
Time Frame
6 months after inclusion
Title
PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome)
Description
Composed og 18 items, the PedsQL Multidimensional Fatigue Scale possesses three subscales: general fatigue, sleep and rest fatigue, and cognitive fatigue.
Time Frame
Within 2 weeks of treatment initiation.
Title
PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome)
Description
Composed og 18 items, the PedsQL Multidimensional Fatigue Scale possesses three subscales: general fatigue, sleep and rest fatigue, and cognitive fatigue.
Time Frame
6 months after inclusion.
Title
PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome)
Description
Composed og 18 items, the PedsQL Multidimensional Fatigue Scale possesses three subscales: general fatigue, sleep and rest fatigue, and cognitive fatigue.
Time Frame
1 month after ended treatment.
Title
PedsQL Multidimensional Fatigue Scale: Young Child, Children, Teens Self-Report and Parent Proxy-Report (explorative outcome)
Description
Composed og 18 items, the PedsQL Multidimensional Fatigue Scale possesses three subscales: general fatigue, sleep and rest fatigue, and cognitive fatigue.
Time Frame
1 year after end of treatment.
Title
Self-Efficacy for Exercise scale (SEE-DK) (explorative outcome)
Description
Self-efficacy for exercise is measured using the Danish version of the SEE scale. This scale contains nine-items concerning nine different potential barriers (weather, activity being tedious, pain, loneliness, disliking the activity, irrelevance, fatigue, stress, sadness) to perform physical exercise.
Time Frame
monthly, up to 6 months after inclusion
Title
Modified Clinical Test of Sensory Interaction in Balance (explorative outcome)
Description
This four-condition test is designed to assess how well an individual is using sensory inputs to maintain balance when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the participant must rely on the somatosensory and vestibular systems to balance. In condition three, the somatosensory system has been compromised and the participant must use vision and the vestibular system to balance. In condition four, vision has been removed and the somatosensory system has been compromised.
Each trial is timed using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall or (d) maintains balance for 30 seconds.
Time Frame
Within 2 weeks of treatment initiation (baseline)
Title
Modified Clinical Test of Sensory Interaction in Balance (explorative outcome)
Description
This four-condition test is designed to assess how well an individual is using sensory inputs to maintain balance when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the participant must rely on the somatosensory and vestibular systems to balance. In condition three, the somatosensory system has been compromised and the participant must use vision and the vestibular system to balance. In condition four, vision has been removed and the somatosensory system has been compromised.
Each trial is timed using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall or (d) maintains balance for 30 seconds.
Time Frame
3-months after inclusion
Title
Modified Clinical Test of Sensory Interaction in Balance (explorative outcome)
Description
This four-condition test is designed to assess how well an individual is using sensory inputs to maintain balance when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the participant must rely on the somatosensory and vestibular systems to balance. In condition three, the somatosensory system has been compromised and the participant must use vision and the vestibular system to balance. In condition four, vision has been removed and the somatosensory system has been compromised.
Each trial is timed using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall or (d) maintains balance for 30 seconds.
Time Frame
6-months after inclusion
Title
Modified Clinical Test of Sensory Interaction in Balance (explorative outcome)
Description
This four-condition test is designed to assess how well an individual is using sensory inputs to maintain balance when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the participant must rely on the somatosensory and vestibular systems to balance. In condition three, the somatosensory system has been compromised and the participant must use vision and the vestibular system to balance. In condition four, vision has been removed and the somatosensory system has been compromised.
Each trial is timed using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall or (d) maintains balance for 30 seconds.
Time Frame
1 month after ended treatment
Title
Modified Clinical Test of Sensory Interaction in Balance (explorative outcome)
Description
This four-condition test is designed to assess how well an individual is using sensory inputs to maintain balance when one or more sensory systems are compromised. In condition one, all sensory systems (i.e., vision, somatosensory, and vestibular) are available for maintaining balance. In condition two, vision has been removed and the participant must rely on the somatosensory and vestibular systems to balance. In condition three, the somatosensory system has been compromised and the participant must use vision and the vestibular system to balance. In condition four, vision has been removed and the somatosensory system has been compromised.
Each trial is timed using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall or (d) maintains balance for 30 seconds.
Time Frame
1 year after ended treatment
Title
Facilitators and Barriers to Physical Activity, semi-structured in-depth interviews (explorative outcome)
Description
We will interview at least 20 children and their parents from the intervention and control group purposely sampled to represent children with high and low physical activity levels, from all centers, representatives for age, diagnosis and sex.
Time Frame
within 6-months after treatment initiation
Title
Physical Activity behaviour (explorative outcome)
Description
Physical activity and sedentary time are assessed by accelerometers worn for 7 days during and after treatment. The accelerometers (ActiGraph™ model GT3X+, ActiGraph LLC, Pensacola FL, USA) measures accelerations of ±6 G. The sample rate will be set to measure raw signals at 100 Hz, translated into metabolic energy equivalents of light, moderate and vigorous physical activity and sedentary time.
Time Frame
1 year after ended treatment.
Title
Physical Activity behaviour (explorative outcome)
Description
Physical activity and sedentary time are assessed by accelerometers worn for 7 days during and after treatment. The accelerometers (ActiGraph™ model GT3X+, ActiGraph LLC, Pensacola FL, USA) measures accelerations of ±6 G. The sample rate will be set to measure raw signals at 100 Hz, translated into metabolic energy equivalents of light, moderate and vigorous physical activity and sedentary time.
Time Frame
1 month after ended treatment.
Title
Physical Activity behaviour (explorative outcome)
Description
Physical activity and sedentary time are assessed by accelerometers worn for 7 days during and after treatment. The accelerometers (ActiGraph™ model GT3X+, ActiGraph LLC, Pensacola FL, USA) measures accelerations of ±6 G. The sample rate will be set to measure raw signals at 100 Hz, translated into metabolic energy equivalents of light, moderate and vigorous physical activity and sedentary time.
Time Frame
6-months after inclusion (primary endpoint).
Title
Physical Activity behaviour (explorative outcome)
Description
Physical activity and sedentary time are assessed by accelerometers worn for 7 days during and after treatment. The accelerometers (ActiGraph™ model GT3X+, ActiGraph LLC, Pensacola FL, USA) measures accelerations of ±6 G. The sample rate will be set to measure raw signals at 100 Hz, translated into metabolic energy equivalents of light, moderate and vigorous physical activity and sedentary time.
Time Frame
3-months after inclusion
Title
Physical Activity behaviour (explorative outcome)
Description
Physical activity and sedentary time are assessed by accelerometers worn for 7 days during and after treatment. The accelerometers (ActiGraph™ model GT3X+, ActiGraph LLC, Pensacola FL, USA) measures accelerations of ±6 G. The sample rate will be set to measure raw signals at 100 Hz, translated into metabolic energy equivalents of light, moderate and vigorous physical activity and sedentary time.
Time Frame
Within 2 weeks of treatment initiation
Title
Risk factors of metabolic syndrome: Body Mass Index
Description
Weight and Height is combined to report BMI in kg/m^2
Time Frame
within 2 weeks of treatment initiation
Title
Risk factors of metabolic syndrome: Body Mass Index
Description
Weight and Height is combined to report BMI in kg/m^2
Time Frame
6 months after inclusion (before a treatment block)
Title
Risk factors of metabolic syndrome: Body Mass Index
Description
Weight and Height is combined to report BMI in kg/m^2
Time Frame
1 month after ended treatment
Title
Risk factors of metabolic syndrome: Body Mass Index
Description
Weight and Height is combined to report BMI in kg/m^2
Time Frame
1 year after end of treatment (primary endpoint)
Title
Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol
Description
Blood samples is reported in mmol/L
Time Frame
within 2 weeks of treatment initiation
Title
Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol
Description
Blood samples is reported in mmol/L
Time Frame
6 months after inclusion (before a treatment block)
Title
Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol
Description
Blood samples is reported in mmol/L
Time Frame
1 month after ended treatment
Title
Risk factors of metabolic syndrome: total cholesterol and low-density lipoprotein (LDL) cholesterol
Description
Blood samples is reported in mmol/L
Time Frame
1 year after end of treatment (primary endpoint)
Title
Risk factors of metabolic syndrome: Oral Glucose Tolerance Test
Description
An Oral Glucose Tolerance Test is performed in the morning following an overnight fast initiated at 10:00 pm the previous evening. Participants will receive 1.75 g/kg of dextrose (maximum of 75 g). Blood will be sampled for serum insulin and plasma glucose at fasting and at 30, 60, 90 and 120 minutes after dextrose administration. Insulin concentrations is determined using an immunochemiluminometric assay. The insulin assay uses a monoclonal anti-insulin antibody and was run on an Immulite2000 machine (Diagnostic Product Corporation, Los Angeles, California).
Time Frame
within 2 weeks of treatment initiation
Title
Risk factors of metabolic syndrome: Oral Glucose Tolerance Test
Description
An Oral Glucose Tolerance Test is performed in the morning following an overnight fast initiated at 10:00 pm the previous evening. Participants will receive 1.75 g/kg of dextrose (maximum of 75 g). Blood will be sampled for serum insulin and plasma glucose at fasting and at 30, 60, 90 and 120 minutes after dextrose administration. Insulin concentrations is determined using an immunochemiluminometric assay. The insulin assay uses a monoclonal anti-insulin antibody and was run on an Immulite2000 machine (Diagnostic Product Corporation, Los Angeles, California).
Time Frame
6 months after inclusion (before a treatment block)
Title
Risk factors of metabolic syndrome: Oral Glucose Tolerance Test
Description
An Oral Glucose Tolerance Test is performed in the morning following an overnight fast initiated at 10:00 pm the previous evening. Participants will receive 1.75 g/kg of dextrose (maximum of 75 g). Blood will be sampled for serum insulin and plasma glucose at fasting and at 30, 60, 90 and 120 minutes after dextrose administration. Insulin concentrations is determined using an immunochemiluminometric assay. The insulin assay uses a monoclonal anti-insulin antibody and was run on an Immulite2000 machine (Diagnostic Product Corporation, Los Angeles, California).
Time Frame
1 month after ended treatment
Title
Risk factors of metabolic syndrome: Oral Glucose Tolerance Test
Description
An Oral Glucose Tolerance Test is performed in the morning following an overnight fast initiated at 10:00 pm the previous evening. Participants will receive 1.75 g/kg of dextrose (maximum of 75 g). Blood will be sampled for serum insulin and plasma glucose at fasting and at 30, 60, 90 and 120 minutes after dextrose administration. Insulin concentrations is determined using an immunochemiluminometric assay. The insulin assay uses a monoclonal anti-insulin antibody and was run on an Immulite2000 machine (Diagnostic Product Corporation, Los Angeles, California).
Time Frame
1 year after end of treatment (primary endpoint)
Title
Risk factors of metabolic syndrome: hip circumference
Description
Hip circumference (in CM) at a level parallel to the floor, at the largest circumference of the buttocks following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
within 2 weeks of treatment initiation
Title
Risk factors of metabolic syndrome: hip circumference
Description
Hip circumference (in CM) at a level parallel to the floor, at the largest circumference of the buttocks following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
6 months after inclusion (before a treatment block)
Title
Risk factors of metabolic syndrome: hip circumference
Description
Hip circumference (in CM) at a level parallel to the floor, at the largest circumference of the buttocks following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
1 month after ended treatment
Title
Risk factors of metabolic syndrome: hip circumference
Description
Hip circumference (in CM) at a level parallel to the floor, at the largest circumference of the buttocks following standards described by the World Health Organization. Metabolic syndrome is based on age-based criterias defined by the International Diabetes Foundation (3).
Time Frame
1 year after end of treatment (primary endpoint)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All malign and benign disorders treated with chemotherapy and/or irradiation
Exclusion Criteria:
Severe mental and/or physical disability, i.e. participants where all types of physical training and testing of physical function are contraindicated
terminal illness
unable to communicate in Danish
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanne B. Larsen, As. Prof.
Phone
0045 35459647
Email
hanne.baekgaard.larsen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus G. Müller, Prof.
Phone
0045 35459647
Email
klaus.muller@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne B. Larsen, As. Prof
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Hasle, Prof.
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanne B Larsen, RN, Msc Soc
Phone
+ 45 22284269
Email
hanne@baekgaard.com
First Name & Middle Initial & Last Name & Degree
Hanne B Larsen, RN, Msc Soc
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sine Lykkedegn, MD, Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24229362
Citation
Thorsteinsson T, Helms AS, Adamsen L, Andersen LB, Andersen KV, Christensen KB, Hasle H, Heilmann C, Hejgaard N, Johansen C, Madsen M, Madsen SA, Simovska V, Strange B, Thing LF, Wehner PS, Schmiegelow K, Larsen HB. Study protocol: Rehabilitation including Social and Physical activity and Education in Children and Teenagers with Cancer (RESPECT). BMC Cancer. 2013 Nov 14;13:544. doi: 10.1186/1471-2407-13-544.
Results Reference
background
PubMed Identifier
27631396
Citation
Fiuza-Luces C, Padilla JR, Soares-Miranda L, Santana-Sosa E, Quiroga JV, Santos-Lozano A, Pareja-Galeano H, Sanchis-Gomar F, Lorenzo-Gonzalez R, Verde Z, Lopez-Mojares LM, Lassaletta A, Fleck SJ, Perez M, Perez-Martinez A, Lucia A. Exercise Intervention in Pediatric Patients with Solid Tumors: The Physical Activity in Pediatric Cancer Trial. Med Sci Sports Exerc. 2017 Feb;49(2):223-230. doi: 10.1249/MSS.0000000000001094.
Results Reference
background
PubMed Identifier
17850473
Citation
Zimmet P, Alberti KG, Kaufman F, Tajima N, Silink M, Arslanian S, Wong G, Bennett P, Shaw J, Caprio S; IDF Consensus Group. The metabolic syndrome in children and adolescents - an IDF consensus report. Pediatr Diabetes. 2007 Oct;8(5):299-306. doi: 10.1111/j.1399-5448.2007.00271.x. No abstract available.
Results Reference
background
PubMed Identifier
35359909
Citation
Schmidt-Andersen P, Fridh MK, Muller KG, Anna Pouplier, Hjalgrim LL, Faigenbaum AD, Schmiegelow K, Hasle H, Lykkedegn S, Zhang H, Christensen J, Larsen HB. Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer (INTERACT): Study Protocol for a Multicenter, Two-Arm Parallel-Group Randomized Controlled Superiority Trial. Front Pediatr. 2022 Mar 14;10:833850. doi: 10.3389/fped.2022.833850. eCollection 2022.
Results Reference
derived
Learn more about this trial
Integrative Neuromuscular Training in Adolescents and Children Treated for Cancer
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