- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05724303
The Effects of Integrative Neuromuscular Training on Physical Function in Overweight Children
February 10, 2023 updated by: St. Mary's University, Twickenham
The Effects of Integrative Neuromuscular Training on Physical Activity, Gait, Strength, and Body Composition in Overweight and Obese Children
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jourdana Durrell
- Phone Number: 07932743222
- Email: jourdana.durrell@stmarys.ac.uk
Study Locations
-
-
London
-
London Borough Of Ealing, London, United Kingdom, UB2 4HT
- Recruiting
- Three Bridges
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 11 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control group
|
|
|
EXPERIMENTAL: Training group
8-week neuromuscular training program
|
Training program consisting of two neuromuscular training sessions per week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in body fat percentage
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
Bioelectrical impedance analysis of fat mass relative to body mass
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in fat free mass
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
Bioelectrical impedance analysis of fat free mass relative to body mass
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in body mass index (BMI)
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
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.
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in Hip 3d gait analysis
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
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.
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in Knee 3d gait analysis
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
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.
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in Ankle 3d gait analysis
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
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.
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in Foot 3d gait analysis
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
Angle of the forefoot, midfoot, rearfoot and shank during the stance phase when walking at a self-selected pace.
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in lower limb strength relative to body mass
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
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
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in lower limb strength relative to fat free mass
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
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
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in physical functioning: six-minute timed walk
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
Distance walked at a self-selected speed for six minutes
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in physical functioning: sit-to-stand test
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
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.
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in physical functioning: timed up and go test
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
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
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in physical functioning: single leg stand eyes open
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
Maximal time to maintain balance on one leg with hands on hip and free leg bent to 90degrees flexion
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in physical functioning: single leg stand eyed closed
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
Maximal time to maintain balance on one leg with eyes closed, hands on hip and free leg bent to 90degrees flexion
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in physical activity: percentage of time spent in sedentary activity levels
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
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.
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in physical activity: percentage of time spent in moderate to vigorous activity levels
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
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.
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
|
Change in motivation towards physical activity
Time Frame: From baseline to end of 8-week training program and to end of 8-week follow-up
|
Behavioural Regulation in Exercise Questionnaire to measure motivation towards physical activity
|
From baseline to end of 8-week training program and to end of 8-week follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
February 24, 2023
Primary Completion (ANTICIPATED)
June 28, 2024
Study Completion (ANTICIPATED)
June 28, 2024
Study Registration Dates
First Submitted
December 15, 2022
First Submitted That Met QC Criteria
February 10, 2023
First Posted (ACTUAL)
February 13, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2023
Last Update Submitted That Met QC Criteria
February 10, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- StMarysUC8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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