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

Study Overview
=================
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.

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

Conditions
-----------------
Pediatric Obesity, Lower Extremity Biomechanics

Intervention / Treatment
-----------------
* Other: Strength and neuromuscular exercise programme


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Strength and neuromuscular exercise programme | Other: Strength and neuromuscular exercise programme<br>* 12 weeks strength and neuromuscular exercise programme for the lower extremity<br>|
| No Intervention: Control<br>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 | Assessed by 3D gait analysis during walking | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 12 weeks | 
| 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. | Baseline and 12 weeks | 
| 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. | Baseline and 12 weeks | 
| 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. | Participants will be followed for the duration of the intervention (12 weeks) | 
| Ratings of knee related pain | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gait Analysis, Knee Adduction Moment, Physiotherapy, Obesity