The Effects of Integrative Neuromuscular Training on Physical Function in Overweight Children
Primary Purpose
Obesity, Childhood Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
8-week neuromuscular training program
Sponsored by
About this trial
This is an interventional basic science trial for Obesity
Eligibility Criteria
Inclusion Criteria: children aged 8-11 years old overweight/obese children Exclusion Criteria: children who have not given consent or had parental consent to participate children who fall outside of the selected age range children who have a physical or mental impairment that will affect their ability to participate in the procedures in the laboratory and intervention settings
Sites / Locations
- Three BridgesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training group
Control group
Arm Description
8-week neuromuscular training program
Outcomes
Primary Outcome Measures
Change in body fat percentage
Bioelectrical impedance analysis of fat mass relative to body mass
Change in fat free mass
Bioelectrical impedance analysis of fat free mass relative to body mass
Change in body mass index (BMI)
BMI calculated with height measured barefoot on weight scales and height measured barefoot on Stadiometer and Z-score based on standard measures for age and gender. A reduction in BMI is a positive change.
Change in Hip 3d gait analysis
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Change in Knee 3d gait analysis
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Change in Ankle 3d gait analysis
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Change in Foot 3d gait analysis
Angle of the forefoot, midfoot, rearfoot and shank during the stance phase when walking at a self-selected pace.
Change in lower limb strength relative to body mass
Lower limb strength measured on Isokinetic Dynamometer in hip flexion/extension, hip abduction/adduction, knee flexion/extension, ankle plantarflexion/dorsiflexion. Maximal moments allometrically scaled to body mass
Change in lower limb strength relative to fat free mass
Lower limb strength measured on Isokinetic Dynamometer in hip flexion/extension, hip abduction/adduction, knee flexion/extension, ankle plantarflexion/dorsiflexion. Maximal moments allometrically scaled to fat free mass
Change in physical functioning: six-minute timed walk
Distance walked at a self-selected speed for six minutes
Change in physical functioning: sit-to-stand test
The amount of repetitions of moving from a sitting position with knees at 90 degrees flexion to an upright standing position and return in one minute. Arms fixed across chest.
Change in physical functioning: timed up and go test
Time taken to rise from a seated position with knees at 90 degrees flexion and arms across chest, walk 3m and return back to seated position
Change in physical functioning: single leg stand eyes open
Maximal time to maintain balance on one leg with hands on hip and free leg bent to 90degrees flexion
Change in physical functioning: single leg stand eyed closed
Maximal time to maintain balance on one leg with eyes closed, hands on hip and free leg bent to 90degrees flexion
Change in physical activity: percentage of time spent in sedentary activity levels
Accelerometer data captured and time spent in sedentary level expressed as a percentage of time worn. Accelerometers worn on right side waist for one week.
Change in physical activity: percentage of time spent in moderate to vigorous activity levels
Accelerometer data captured and time spent in moderate to vigorous level expressed as a percentage of time worn. Accelerometers worn on right side waist for one week.
Change in motivation towards physical activity
Behavioural Regulation in Exercise Questionnaire to measure motivation towards physical activity
Secondary Outcome Measures
Full Information
NCT ID
NCT05724303
First Posted
December 15, 2022
Last Updated
February 10, 2023
Sponsor
St. Mary's University, Twickenham
1. Study Identification
Unique Protocol Identification Number
NCT05724303
Brief Title
The Effects of Integrative Neuromuscular Training on Physical Function in Overweight Children
Official Title
The Effects of Integrative Neuromuscular Training on Physical Activity, Gait, Strength, and Body Composition in Overweight and Obese Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Anticipated)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
June 28, 2024 (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
5. Study Description
Brief Summary
Childhood obesity is an ongoing and increasing issue, resulting in changes in body mass which cause biomechanical alterations in the lower limbs. Exercise interventions have been effectiveness at causing positive changes to the lower limbs gait, strength and functioning but children often report lack of enjoyment from the sessions which inhibits long term changes. This intervention takes a neuromuscular exercise approach whilst considering the psychological needs of children to motivate them to participate in the intervention and physical activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training group
Arm Type
Experimental
Arm Description
8-week neuromuscular training program
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
8-week neuromuscular training program
Intervention Description
Training program consisting of two neuromuscular training sessions per week
Primary Outcome Measure Information:
Title
Change in body fat percentage
Description
Bioelectrical impedance analysis of fat mass relative to body mass
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in fat free mass
Description
Bioelectrical impedance analysis of fat free mass relative to body mass
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in body mass index (BMI)
Description
BMI calculated with height measured barefoot on weight scales and height measured barefoot on Stadiometer and Z-score based on standard measures for age and gender. A reduction in BMI is a positive change.
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in Hip 3d gait analysis
Description
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in Knee 3d gait analysis
Description
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in Ankle 3d gait analysis
Description
3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in Foot 3d gait analysis
Description
Angle of the forefoot, midfoot, rearfoot and shank during the stance phase when walking at a self-selected pace.
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in lower limb strength relative to body mass
Description
Lower limb strength measured on Isokinetic Dynamometer in hip flexion/extension, hip abduction/adduction, knee flexion/extension, ankle plantarflexion/dorsiflexion. Maximal moments allometrically scaled to body mass
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in lower limb strength relative to fat free mass
Description
Lower limb strength measured on Isokinetic Dynamometer in hip flexion/extension, hip abduction/adduction, knee flexion/extension, ankle plantarflexion/dorsiflexion. Maximal moments allometrically scaled to fat free mass
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in physical functioning: six-minute timed walk
Description
Distance walked at a self-selected speed for six minutes
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in physical functioning: sit-to-stand test
Description
The amount of repetitions of moving from a sitting position with knees at 90 degrees flexion to an upright standing position and return in one minute. Arms fixed across chest.
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in physical functioning: timed up and go test
Description
Time taken to rise from a seated position with knees at 90 degrees flexion and arms across chest, walk 3m and return back to seated position
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in physical functioning: single leg stand eyes open
Description
Maximal time to maintain balance on one leg with hands on hip and free leg bent to 90degrees flexion
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in physical functioning: single leg stand eyed closed
Description
Maximal time to maintain balance on one leg with eyes closed, hands on hip and free leg bent to 90degrees flexion
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in physical activity: percentage of time spent in sedentary activity levels
Description
Accelerometer data captured and time spent in sedentary level expressed as a percentage of time worn. Accelerometers worn on right side waist for one week.
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in physical activity: percentage of time spent in moderate to vigorous activity levels
Description
Accelerometer data captured and time spent in moderate to vigorous level expressed as a percentage of time worn. Accelerometers worn on right side waist for one week.
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
Title
Change in motivation towards physical activity
Description
Behavioural Regulation in Exercise Questionnaire to measure motivation towards physical activity
Time Frame
From baseline to end of 8-week training program and to end of 8-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
children aged 8-11 years old
overweight/obese children
Exclusion Criteria:
children who have not given consent or had parental consent to participate
children who fall outside of the selected age range
children who have a physical or mental impairment that will affect their ability to participate in the procedures in the laboratory and intervention settings
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jourdana Durrell
Phone
07932743222
Email
jourdana.durrell@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
Three Bridges
City
London Borough Of Ealing
State/Province
London
ZIP/Postal Code
UB2 4HT
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Integrative Neuromuscular Training on Physical Function in Overweight Children
We'll reach out to this number within 24 hrs