Clinical trial NCT02545764: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Lower Extremity Biomechanics
Keywords: Gait Analysis
Knee Adduction Moment
Physiotherapy
Obesity
Lead sponsor: St. Pölten University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: University of Vienna
name: Medical University of Vienna
name: Danube University Krems
First posted: 2015-09-10
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall peak external frontal knee moment and impulse
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Physical examination
timeFrame: Baseline and 12 weeks
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline and 12 weeks
measure: Gait pattern
timeFrame: Baseline and 12 weeks
measure: Adherence to the training programme
timeFrame: Participants will be followed for the duration of the intervention (12 weeks)
measure: Ratings of knee related pain
timeFrame: Participants will be followed for the duration of the intervention (12 weeks)
Other outcomes:
measure: Cardiopulmonary testing
timeFrame: Baseline and 12 weeks
measure: Anthropometric measures
timeFrame: Baseline and 12 weeks
measure: Body Composition
timeFrame: Baseline and 12 weeks
measure: Nutritional status
timeFrame: Baseline and 12 weeks
measure: Psychological status
timeFrame: Baseline and 12 weeks
measure: Blood samples
timeFrame: Baseline and 12 weeks
Locations:
city: Vienna
country: Austria
facility: Department of Paediatrics and Adolescent Medicine, Medical University of Vienna
Study officials:
References:
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.
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.
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.