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

Primary Purpose

Pediatric Obesity, Lower Extremity Biomechanics

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Strength and neuromuscular exercise programme
Sponsored by
St. Pölten University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Gait Analysis, Knee Adduction Moment, Physiotherapy, Obesity

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Strength and neuromuscular exercise programme

Control group will receive opportunity for the training programme after data capturing is finished

Outcomes

Primary Outcome Measures

Overall peak external frontal knee moment and impulse
Assessed by 3D gait analysis during walking

Secondary Outcome Measures

Physical examination
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.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Austria-German version of the Knee Injury and Osteoarthritis Outcome Score will be used to assess the participants' opinion about their knee.
Gait pattern
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.
Adherence to the training programme
Adherence will be considered as the percentage of actually completed sessions during the intervention period among the number of intended exercise sessions.
Ratings of knee related pain
Ratings of knee related pain will be assessed using a 7-point ordinal scale.

Full Information

First Posted
August 28, 2015
Last Updated
July 16, 2018
Sponsor
St. Pölten University of Applied Sciences
Collaborators
University of Vienna, Medical University of Vienna, Danube University Krems
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1. Study Identification

Unique Protocol Identification Number
NCT02545764
Brief Title
Training Induced Reduction of Lower-limb Joint Loads During Locomotion in Obese Children
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Pölten University of Applied Sciences
Collaborators
University of Vienna, Medical University of Vienna, Danube University Krems

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Lower Extremity Biomechanics
Keywords
Gait Analysis, Knee Adduction Moment, Physiotherapy, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Strength and neuromuscular exercise programme
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group will receive opportunity for the training programme after data capturing is finished
Intervention Type
Other
Intervention Name(s)
Strength and neuromuscular exercise programme
Intervention Description
12 weeks strength and neuromuscular exercise programme for the lower extremity
Primary Outcome Measure Information:
Title
Overall peak external frontal knee moment and impulse
Description
Assessed by 3D gait analysis during walking
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Physical examination
Description
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.
Time Frame
Baseline and 12 weeks
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
The Austria-German version of the Knee Injury and Osteoarthritis Outcome Score will be used to assess the participants' opinion about their knee.
Time Frame
Baseline and 12 weeks
Title
Gait pattern
Description
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.
Time Frame
Baseline and 12 weeks
Title
Adherence to the training programme
Description
Adherence will be considered as the percentage of actually completed sessions during the intervention period among the number of intended exercise sessions.
Time Frame
Participants will be followed for the duration of the intervention (12 weeks)
Title
Ratings of knee related pain
Description
Ratings of knee related pain will be assessed using a 7-point ordinal scale.
Time Frame
Participants will be followed for the duration of the intervention (12 weeks)
Other Pre-specified Outcome Measures:
Title
Cardiopulmonary testing
Description
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.
Time Frame
Baseline and 12 weeks
Title
Anthropometric measures
Description
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.
Time Frame
Baseline and 12 weeks
Title
Body Composition
Description
Body composition parameters will include, fat mass, fat free mass, total body water, body cell mass, extracellular mass and lean body mass.
Time Frame
Baseline and 12 weeks
Title
Nutritional status
Description
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.
Time Frame
Baseline and 12 weeks
Title
Psychological status
Description
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.
Time Frame
Baseline and 12 weeks
Title
Blood samples
Description
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.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Paediatrics and Adolescent Medicine, Medical University of Vienna
City
Vienna
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
30898093
Citation
Kreissl A, Jorda A, Truschner K, Skacel G, Greber-Platzer S. Clinically relevant body composition methods for obese pediatric patients. BMC Pediatr. 2019 Mar 21;19(1):84. doi: 10.1186/s12887-019-1454-2.
Results Reference
derived
PubMed Identifier
30851623
Citation
Horsak B, Schwab C, Baca A, Greber-Platzer S, Kreissl A, Nehrer S, Keilani M, Crevenna R, Kranzl A, Wondrasch B. Effects of a lower extremity exercise program on gait biomechanics and clinical outcomes in children and adolescents with obesity: A randomized controlled trial. Gait Posture. 2019 May;70:122-129. doi: 10.1016/j.gaitpost.2019.02.032. Epub 2019 Feb 27.
Results Reference
derived
PubMed Identifier
26700568
Citation
Horsak B, Artner D, Baca A, Pobatschnig B, Greber-Platzer S, Nehrer S, Wondrasch B. The effects of a strength and neuromuscular exercise programme for the lower extremity on knee load, pain and function in obese children and adolescents: study protocol for a randomised controlled trial. Trials. 2015 Dec 23;16:586. doi: 10.1186/s13063-015-1091-5.
Results Reference
derived

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

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