Effects of Whole-body Vibration Training on Body Composition in Adolescents With and Without Down Syndrome

Not Applicable

Completed

• Conditions: Down Syndrome
• Interventions: Device: Whole-body vibration training (Power Plate®) on bone mass and bone metabolism in adolescents with and without Down syndrome.

• Registration Number: NCT02380638
• Lead Sponsor: Universidad de Zaragoza

Brief Summary

The main aims of the present project include 1) to study the longitudinal effects of whole-body vibratory exercise on bone metabolism in adolescents with and without DS and 2) to evaluate whether a low frequency vibratory training program consisting of 3 sessions per week for 9 months (each vibratory session last approximately 10 minutes and includes 5-6 bouts of 1 min with 1 min rest between bouts) can improve bone development in these populations. Finally, and additional aim of the project is 3) to determine how long these effects may last after the end of the intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Status Verified: 2015-02
• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-02-27
• Last Update Submitted: 2015-02-27
• Study First Posted: 2015-03-05
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Both groups: Ages 10 - 19.
• Both groups: Parental/guardian permission (informed consent) and if appropriate, child verbal assent.
• Down syndrome group only: Diagnosis of Down syndrome.

Exclusion Criteria

• Taking medication affecting bone.
• Non-caucasian.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DS-WBV	Whole-body vibration training (Power Plate®) on bone mass and bone metabolism in adolescents with and without Down syndrome.	Exercise with Whole-body vibration (WBV) platform (Power Plate®). The participants will perform squat on a vibratory platform (3 times per week; 10 repetitions 30 to 60 seconds; Frequency: 25-30 Hz; Amplitude: 2 mm).
NONDS-WBV	Whole-body vibration training (Power Plate®) on bone mass and bone metabolism in adolescents with and without Down syndrome.	Exercise with Whole-body vibration (WBV) platform (Power Plate®). The participants will perform squat on a vibratory platform (3 times per week; 10 repetitions 30 to 60 seconds; Frequency: 25-30 Hz; Amplitude: 2 mm).

Primary Outcome Measures

Name	Time	Method
Changes from baseline in body composition assessed with dual energy X-ray at different time points, 6 months and 15 months.	Changes from baseline in body composition at 6 months and changes from baseline in body composition at 15 months

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in bone structure evaluated with peripheral quantitative computed tomography at different time points, 6 months and 15 months.	Changes from baseline in bone structure at 6 months and changes from baseline in bone structure at 15 months

Trial Locations

Locations (1)

GENUD Research Group; 🇪🇸 Zaragoza, Spain