NCT02545764

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

August 28, 2015

Last Update Submit

July 16, 2018

Conditions

Pediatric ObesityLower Extremity Biomechanics

Keywords

Gait AnalysisKnee Adduction MomentPhysiotherapyObesity

Outcome Measures

Primary Outcomes (1)

  • Overall peak external frontal knee moment and impulse

    Assessed by 3D gait analysis during walking

    Baseline and 12 weeks

Secondary Outcomes (5)

  • Physical examination

    Baseline and 12 weeks

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Baseline and 12 weeks

  • Gait pattern

    Baseline and 12 weeks

  • Adherence to the training programme

    Participants will be followed for the duration of the intervention (12 weeks)

  • Ratings of knee related pain

    Participants will be followed for the duration of the intervention (12 weeks)

Other Outcomes (6)

  • Cardiopulmonary testing

    Baseline and 12 weeks

  • Anthropometric measures

    Baseline and 12 weeks

  • Body Composition

    Baseline and 12 weeks

  • +3 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Strength and neuromuscular exercise programme

Other: Strength and neuromuscular exercise programme

Control

NO INTERVENTION

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

Interventions

Strength and neuromuscular exercise programmeOTHER

12 weeks strength and neuromuscular exercise programme for the lower extremity

Intervention

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Paediatrics and Adolescent Medicine, Medical University of Vienna

Vienna, Austria

Location

Related Publications (3)

  • 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.

    PMID: 30898093DERIVED

  • 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.

    PMID: 30851623DERIVED

  • 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.

    PMID: 26700568DERIVED

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 10, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2017

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

AU(1)