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

Pediatric Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545764
• Other study ID #: LS13-009
• Status: Completed
• Phase: N/A
• Start date: September 2015

Study information

• Verified date: July 2018
• Source: St. Pölten University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Extremity Biomechanics
• Pediatric Obesity

Intervention

Other:
• Strength and neuromuscular exercise programme
12 weeks strength and neuromuscular exercise programme for the lower extremity

Locations

Country	Name	City	State
Austria	Department of Paediatrics and Adolescent Medicine, Medical University of Vienna	Vienna

Sponsors (4)

Lead Sponsor	Collaborator
St. Pölten University of Applied Sciences	Danube University Krems, Medical University of Vienna, University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiopulmonary testing	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.	Baseline and 12 weeks
Other	Anthropometric measures	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.	Baseline and 12 weeks
Other	Body Composition	Body composition parameters will include, fat mass, fat free mass, total body water, body cell mass, extracellular mass and lean body mass.	Baseline and 12 weeks
Other	Nutritional status	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.	Baseline and 12 weeks
Other	Psychological status	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.	Baseline and 12 weeks
Other	Blood samples	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.	Baseline and 12 weeks
Primary	Overall peak external frontal knee moment and impulse	Assessed by 3D gait analysis during walking	Baseline and 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)