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Completed

NCT Number: NCT02545764

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

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.

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Key information

Conditions

Pediatric Obesity Body Weight Lower Extremity Biomechanics Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Paediatrics and Adolescent Medicine, Medical University of Vienna

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strength and neuromuscular exercise programme

Other

12 weeks strength and neuromuscular exercise programme for the lower extremity

Primary outcomes

  1. Overall peak external frontal knee moment and impulse

    Time frame: Baseline and 12 weeks

    Assessed by 3D gait analysis during walking

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

St. Pölten University of Applied Sciences

Other

Collaborators

  • Danube University Krems
  • Medical University of Vienna
  • University of Vienna

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
First posted
Sep 10, 2015
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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