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

• Sponsor: Universidad de Zaragoza (Other)
• Overall Status: Completed
• CT.gov ID: NCT02380638
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 4
• Duration (Months): 35
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome	Device: Whole-body vibration training (Power Plate®) on bone mass and bone metabolism in adolescents with and without Down syndrome.	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GENUD Research Group	Zaragoza		Spain	50009

Sponsors and Collaborators

• Universidad de Zaragoza

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: José A. Casajús, MD, PhD., Universidad de Zaragoza
• ClinicalTrials.gov Identifier: NCT02380638
• Other Study ID Numbers: DEP2009-09183
• First Posted: Mar 5, 2015
• Last Update Posted: Mar 5, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Down Syndrome; Syndrome

Study Results

No Results Posted as of Mar 5, 2015