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

February 27, 2015 updated by: José A. Casajús, Universidad de Zaragoza

Effects of Whole-body Vibration Training on Bone Mass and Bone Metabolism in Adolescents With Down Syndrome / Efectos Del Entrenamiento Vibratorio en la Masa ósea y el Metabolismo óseo de Adolescentes Con síndrome de Down

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • GENUD Research group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DS-WBV
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).
Device: Whole-body vibration training (Power Plate®) on bone mass and bone metabolism in adolescents with and without Down syndrome.
No Intervention: DS-NONWBV
This group will continue with their day-to-day lifestyle during the course of the project.
Experimental: NONDS-WBV
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).
Device: Whole-body vibration training (Power Plate®) on bone mass and bone metabolism in adolescents with and without Down syndrome.
No Intervention: NONDS-NONWBV
This group will continue with their day-to-day lifestyle during the course of the project.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Zaragoza

Investigators

  • Principal Investigator: José A. Casajús, MD, PhD, GENUD Research group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

February 27, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEP2009-09183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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