The Effects of Strength and Balance Training on Physical Function in Overweight Children
Primary Purpose
Obesity, Childhood
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Eight-week in-school strength and balance training program
Sponsored by
About this trial
This is an interventional basic science trial for Obesity, Childhood
Eligibility Criteria
Inclusion Criteria: Overweight or obese Exclusion Criteria: -
Sites / Locations
- Orchard Primary schoolRecruiting
- Isleworth Town Primary SchoolRecruiting
- Beavers Primary SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training group
Control
Arm Description
Eight-week in-school strength and balance training program
No intervention, normal activities.
Outcomes
Primary Outcome Measures
Change in Body Mass Index Z-Score
Body mass index will be calculated as body mass (kg) / height (m)2. Body mass will be measured using weighing scales and height by stadiometer whilst participants are barefooted with simple clothing (shorts and t-shirt). Z-scores denote the standard deviations that BMI for gender and height are from the mean of United Kingdom child reference curves. A higher z-score means greater BMI than the mean for child gender and height.
Change in body fat percentage
Bioelectrical impedance will be used to determine whole-body impedance. Population-specific equations will be applied to estimate body fat (kg). The percentage of body fat will be calculated as (Fat Mass (kg)/Body Mass(kg))*100.
Change in fat free mass (kg)
Bioelectrical impedance will be used to determine whole-body impedance. Population-specific equations will be applied to estimate body fat (kg). Fat-free mass will be calculated as Body Mass (kg) - fat mass (kg).
Change in lower limb 3D gait.
Joint angles, moments, and power waveforms of hip, knee and ankle in three dimensions during the stance phase of self-paced walking. Change in lower limb 3D gait will be determined via a previously validated marker set for obese children, time normalised to 100% of stance phase, and moment and power will be dimensionless normalised to body mass and leg length.
Change in 3D foot in gait.
The angle of the forefoot, midfoot, rearfoot and shank in three dimensions during the stance phase of self-paced walking. Change in foot 3D gait will be determined via a previously validated marker set for obese children, and time normalised to 100% of the stance phase.
Change in lower limb muscular strength relative to body mass.
Isokinetic dynamometry will be used to determine the maximal strength of hip extension, hip flexion, hip adduction, hip abduction, knee extension, knee flexion, ankle plantarflexion, and ankle dorsiflexion. Maximal moments will be allometrically scaled to body mass.
Change in lower limb muscular strength relative to fat free mass.
Isokinetic dynamometry will be used to determine the maximal strength of hip extension, hip flexion, hip adduction, hip abduction, knee extension, knee flexion, ankle plantarflexion, and ankle dorsiflexion. Maximal moments will be allometrically scaled to fat-free mass.
Change in six minute walk distance.
The maximal distance walked in six minutes will be recorded in meters.
Change in sit to stand repetitions
The maximal number of times participants are able to stand up and sit down in one minute. The stool used will be adjusted so the participant's knee is at 90 degrees when seated, and arms will be placed across the chest.
Change in timed up and go time
The time (seconds) it takes participants to stand from seated (knees 90 degrees), arms across chest, walk 3m turn and go back to seating.
Change in single leg stance time
The maximum amount of time participants are able to maintain stance on their dominant limb with the non-dominant limb flexed 90 degrees and hands held on the waist. The test is stopped when the non-dominant limb touches the ground, participants move their hands or dominant limb to maintain balance.
Change in single leg stance time with eye closed
The maximum amount of time participants are able to maintain stance on their dominant limb with the non-dominant limb flexed 90 degrees and hands held on the waist and with their eyes closed. The test is stopped when the non-dominant limb touches the ground, participants move their hands or dominant limb to maintain balance.
Change in percentage of time spent in sedentary activity.
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Child-specific cutoff equations will be used to determine times of sedentary behaviour. Total time in mins will be divided by total wear time to get percentage of time in sedentary activity.
Change in percentage of time spent in moderate to vigorous activity.
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Child-specific cutoff equations will be used to determine times spent in moderate to vigorous physical activity. Total time in mins will be divided by total wear time to get the percentage of time in moderate to vigorous activity.
Change in total vector magnitude counts
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Vector magnitude counts are a total raw measure of movement.
Change in quality of life score.
Previously validated Paediatric Quality of Life (PedsQL; physical function section only) will be completed on a 5-point Likert scale and scored. Items are reversed, scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. If more than 50% of the items in the scale are missing, the scale scores should not be computed; mean score = Sum of the items over the number of items answered. A higher score denotes a better quality of life whilst a lower score suggests a poorer quality of life.
Change in pain reported now
Previously validated paediatric pain questionnaire visual analogue scale for present pain. 10cm (100mm) visual analogue scales from 0 (Not hurting / No discomfort / No pain) to 10 (100) (Hurting a whole lot / Very uncomfortable / Severe pain). The value will be presented as mm from 0. A higher value means greater pain is present.
Change in worst pain
Previously validated paediatric pain questionnaire visual analogue scale for worst pain in last seven days.10cm (100mm) visual analogue scales from 0 (Not hurting / No discomfort / No pain) to 10 (100) (Hurting a whole lot / Very uncomfortable / Severe pain). The value will be presented as mm from 0. A higher value means greater pain is present.
Change in physical activity enjoyment scale
Previously validated 16-item 5-point Likert scale from 1 (I disagree a lot) to 5 (I agree a lot). Negatively worded sites are reverse scored, and the overall enjoyment for physical activity score is determined by summing all items. A higher score means greater enjoyment of physical activity.
Change in basic psychological needs in exercise scale score
Previously validated 18-item 5-point Likert scale from 1 (I disagree a lot) to 5 (I agree a lot). An average score for each subdivision of autonomy, competence, relatedness and teacher relatedness is calculated. A higher score means positive support felt for each subdivision.
Secondary Outcome Measures
Full Information
NCT ID
NCT05665621
First Posted
December 16, 2022
Last Updated
February 27, 2023
Sponsor
St. Mary's University, Twickenham
1. Study Identification
Unique Protocol Identification Number
NCT05665621
Brief Title
The Effects of Strength and Balance Training on Physical Function in Overweight Children
Official Title
The Effect of Strength and Combined Balance Training Intervention Programme on Physical Function, Physical Activity, and Musculoskeletal Health in Children With Overweight and Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Anticipated)
Primary Completion Date
August 13, 2023 (Anticipated)
Study Completion Date
August 13, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Mary's University, Twickenham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This intervention study aims to examine the efficacy of a school-based exercise programme to improve strength and balance in overweight and obese 7-11-year-olds in the United Kingdom. The main question[s] it aims to answer are:
Is the school-based exercise programme effective in improving lower limb muscular strength and balance control?
How do increases in strength and balance skills impact physical function, the risk to musculoskeletal health, and physical activity? Participants will attend baseline, post-intervention, and follow-up testing that includes assessment of strength, balance, 3D gait, plantar pressure, physical function and physical activity. The intervention group will take part in physical activity sessions in their school for 1 hour twice a week for a total of 8 weeks.
Researchers will compare the intervention group to a control group that will take part in no-activity sessions and carry out their normal school and seasonal activities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training group
Arm Type
Experimental
Arm Description
Eight-week in-school strength and balance training program
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention, normal activities.
Intervention Type
Other
Intervention Name(s)
Eight-week in-school strength and balance training program
Intervention Description
Training program consisting of two 1-hour strength and balance training sessions per week.
Primary Outcome Measure Information:
Title
Change in Body Mass Index Z-Score
Description
Body mass index will be calculated as body mass (kg) / height (m)2. Body mass will be measured using weighing scales and height by stadiometer whilst participants are barefooted with simple clothing (shorts and t-shirt). Z-scores denote the standard deviations that BMI for gender and height are from the mean of United Kingdom child reference curves. A higher z-score means greater BMI than the mean for child gender and height.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in body fat percentage
Description
Bioelectrical impedance will be used to determine whole-body impedance. Population-specific equations will be applied to estimate body fat (kg). The percentage of body fat will be calculated as (Fat Mass (kg)/Body Mass(kg))*100.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in fat free mass (kg)
Description
Bioelectrical impedance will be used to determine whole-body impedance. Population-specific equations will be applied to estimate body fat (kg). Fat-free mass will be calculated as Body Mass (kg) - fat mass (kg).
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in lower limb 3D gait.
Description
Joint angles, moments, and power waveforms of hip, knee and ankle in three dimensions during the stance phase of self-paced walking. Change in lower limb 3D gait will be determined via a previously validated marker set for obese children, time normalised to 100% of stance phase, and moment and power will be dimensionless normalised to body mass and leg length.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in 3D foot in gait.
Description
The angle of the forefoot, midfoot, rearfoot and shank in three dimensions during the stance phase of self-paced walking. Change in foot 3D gait will be determined via a previously validated marker set for obese children, and time normalised to 100% of the stance phase.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in lower limb muscular strength relative to body mass.
Description
Isokinetic dynamometry will be used to determine the maximal strength of hip extension, hip flexion, hip adduction, hip abduction, knee extension, knee flexion, ankle plantarflexion, and ankle dorsiflexion. Maximal moments will be allometrically scaled to body mass.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in lower limb muscular strength relative to fat free mass.
Description
Isokinetic dynamometry will be used to determine the maximal strength of hip extension, hip flexion, hip adduction, hip abduction, knee extension, knee flexion, ankle plantarflexion, and ankle dorsiflexion. Maximal moments will be allometrically scaled to fat-free mass.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in six minute walk distance.
Description
The maximal distance walked in six minutes will be recorded in meters.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in sit to stand repetitions
Description
The maximal number of times participants are able to stand up and sit down in one minute. The stool used will be adjusted so the participant's knee is at 90 degrees when seated, and arms will be placed across the chest.
Time Frame
Baseline to end of 8-week intervention and to end of 8-week follow up period.
Title
Change in timed up and go time
Description
The time (seconds) it takes participants to stand from seated (knees 90 degrees), arms across chest, walk 3m turn and go back to seating.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in single leg stance time
Description
The maximum amount of time participants are able to maintain stance on their dominant limb with the non-dominant limb flexed 90 degrees and hands held on the waist. The test is stopped when the non-dominant limb touches the ground, participants move their hands or dominant limb to maintain balance.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in single leg stance time with eye closed
Description
The maximum amount of time participants are able to maintain stance on their dominant limb with the non-dominant limb flexed 90 degrees and hands held on the waist and with their eyes closed. The test is stopped when the non-dominant limb touches the ground, participants move their hands or dominant limb to maintain balance.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in percentage of time spent in sedentary activity.
Description
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Child-specific cutoff equations will be used to determine times of sedentary behaviour. Total time in mins will be divided by total wear time to get percentage of time in sedentary activity.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in percentage of time spent in moderate to vigorous activity.
Description
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Child-specific cutoff equations will be used to determine times spent in moderate to vigorous physical activity. Total time in mins will be divided by total wear time to get the percentage of time in moderate to vigorous activity.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in total vector magnitude counts
Description
Tri-axial accelerometry will be used to determine physical activity over three days (including one weekend day). Vector magnitude counts are a total raw measure of movement.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in quality of life score.
Description
Previously validated Paediatric Quality of Life (PedsQL; physical function section only) will be completed on a 5-point Likert scale and scored. Items are reversed, scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. If more than 50% of the items in the scale are missing, the scale scores should not be computed; mean score = Sum of the items over the number of items answered. A higher score denotes a better quality of life whilst a lower score suggests a poorer quality of life.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in pain reported now
Description
Previously validated paediatric pain questionnaire visual analogue scale for present pain. 10cm (100mm) visual analogue scales from 0 (Not hurting / No discomfort / No pain) to 10 (100) (Hurting a whole lot / Very uncomfortable / Severe pain). The value will be presented as mm from 0. A higher value means greater pain is present.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in worst pain
Description
Previously validated paediatric pain questionnaire visual analogue scale for worst pain in last seven days.10cm (100mm) visual analogue scales from 0 (Not hurting / No discomfort / No pain) to 10 (100) (Hurting a whole lot / Very uncomfortable / Severe pain). The value will be presented as mm from 0. A higher value means greater pain is present.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in physical activity enjoyment scale
Description
Previously validated 16-item 5-point Likert scale from 1 (I disagree a lot) to 5 (I agree a lot). Negatively worded sites are reverse scored, and the overall enjoyment for physical activity score is determined by summing all items. A higher score means greater enjoyment of physical activity.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Title
Change in basic psychological needs in exercise scale score
Description
Previously validated 18-item 5-point Likert scale from 1 (I disagree a lot) to 5 (I agree a lot). An average score for each subdivision of autonomy, competence, relatedness and teacher relatedness is calculated. A higher score means positive support felt for each subdivision.
Time Frame
Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Overweight or obese
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Le Warne, MRes
Phone
020 8240 4034
Email
megan.lewarne@stmarys.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Mahaffey, PhD
Organizational Affiliation
St. Mary's University, Twickenham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orchard Primary school
City
Hounslow
State/Province
Greater London
ZIP/Postal Code
TW4 5JW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Isleworth Town Primary School
City
Isleworth
State/Province
Greater London
ZIP/Postal Code
TW7 6AB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Beavers Primary School
City
Hounslow
State/Province
London
ZIP/Postal Code
TW4 6HR
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Strength and Balance Training on Physical Function in Overweight Children
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