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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Control group
EXPERIMENTAL: Training group
8-week neuromuscular training program
Other: 8-week neuromuscular training program
Training program consisting of two neuromuscular training sessions per week

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Mary's University, Twickenham

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2023

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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