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

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

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

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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