Training Induced Reduction of Lower-limb Joint Loads During Locomotion in Obese Children

July 16, 2018 updated by: St. Pölten University of Applied Sciences

The Effects of a Strength and Neuromuscular Exercise Programme for the Lower Extremity on Knee Load, Pain and Function in Obese Children and Adolescents: a Randomised, Single-blinded Controlled Trial

Childhood obesity is one of the most critical and accelerating health challenges throughout the world. It is a major risk factor for developing varus/valgus misalignments of the knee joint. The combination of misalignment at the knee and excess body mass may result in increased joint stress and damage to articular cartilage. A training programme, which aims at developing a more neutral alignment of the trunk and lower limbs during movement tasks may be able to reduce knee loading during locomotion. Despite the large number of guidelines for muscle strength training and neuromuscular exercises that exists, most are not specifically designed to target the obese children and adolescent demographic.

The purpose of this study is to evaluate a training programme which combines strength and neuromuscular exercises specifically designed to the needs and limitations of obese children and adolescents and analyse the effects of the training programme from a biomechanical and clinical point of view.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

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 Locations

  • Austria
      • Vienna, Austria
        • Department of Paediatrics and Adolescent Medicine, Medical University of Vienna

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

6 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female
  • Age: 10 -18 years
  • BMI greater than the 97th percentile
  • Availability: can participate in two exercises session per week for a period of 12 weeks

Exclusion Criteria:

  • Present syndromes
  • Chronic joint diseases, osteoarthritic surgery or
  • Neuro-motor diseases

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Strength and neuromuscular exercise programme
Other: Strength and neuromuscular exercise programme
12 weeks strength and neuromuscular exercise programme for the lower extremity
No Intervention: Control
Control group will receive opportunity for the training programme after data capturing is finished

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall peak external frontal knee moment and impulse
Time Frame: Baseline and 12 weeks
Assessed by 3D gait analysis during walking
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical examination
Time Frame: Baseline and 12 weeks
Changes of function and strength of the targeted muscle groups will be assessed by a physical therapist. Therefore, a hand-dynamometer to investigate differences in muscle strength will be used.
Baseline and 12 weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline and 12 weeks
The Austria-German version of the Knee Injury and Osteoarthritis Outcome Score will be used to assess the participants' opinion about their knee.
Baseline and 12 weeks
Gait pattern
Time Frame: Baseline and 12 weeks
Kinematics and external joint moments for the sagittal and frontal plane for hip, knee and ankle joints as well as spatio-temporal parameters will be assessed by 3D gait analysis during walking and stair climbing.
Baseline and 12 weeks
Adherence to the training programme
Time Frame: Participants will be followed for the duration of the intervention (12 weeks)
Adherence will be considered as the percentage of actually completed sessions during the intervention period among the number of intended exercise sessions.
Participants will be followed for the duration of the intervention (12 weeks)
Ratings of knee related pain
Time Frame: Participants will be followed for the duration of the intervention (12 weeks)
Ratings of knee related pain will be assessed using a 7-point ordinal scale.
Participants will be followed for the duration of the intervention (12 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiopulmonary testing
Time Frame: Baseline and 12 weeks
The influence of the training programme on aerobic fitness will be assessed by submitting the participants to a symptom-limited cardiopulmonary exercise testing on a cycle ergometer.
Baseline and 12 weeks
Anthropometric measures
Time Frame: Baseline and 12 weeks
The anthropometric evaluation will include the measurement of height, weight, waist circumference, hip circumference, waist-to-hip ratio and calculation of the body mass index.
Baseline and 12 weeks
Body Composition
Time Frame: Baseline and 12 weeks
Body composition parameters will include, fat mass, fat free mass, total body water, body cell mass, extracellular mass and lean body mass.
Baseline and 12 weeks
Nutritional status
Time Frame: Baseline and 12 weeks
The nutritional status will be assessed using the 24-hour recall method. This method records the daily, self-reported consumption of food-intake. In combination with a standardized nutritional food programme (EBISpro) the intake of macro- and micronutrients will be estimated.
Baseline and 12 weeks
Psychological status
Time Frame: Baseline and 12 weeks
The AD-EVA test inventory as well as the Child Behavior Checklist (CBCL/4 -18 ) will be used to determine the psychological status of the participants.
Baseline and 12 weeks
Blood samples
Time Frame: Baseline and 12 weeks
Quantification of routine blood sampling in obese patients and growth hormones and inflammation will be performed from venous blood samples in the Laboratory of the Department of Pediatrics and Adolescent Medicine at the Medical University of Vienna.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Pölten University of Applied Sciences

Collaborators

Medical University of Vienna
University of Vienna
Danube University Krems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimate)

September 10, 2015

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LS13-009

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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