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

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380638
• Other study ID #: DEP2009-09183
• Status: Completed
• Phase: N/A
• First received: February 20, 2015
• Last updated: February 27, 2015
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: February 2015
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: CEICA Gobierno de Aragón
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 19 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Spain	GENUD Research Group	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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