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

Primary Purpose

Down Syndrome

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Down Syndrome

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

GENUD Research Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

DS-WBV

DS-NONWBV

NONDS-WBV

NONDS-NONWBV

Arm Description

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).

This group will continue with their day-to-day lifestyle during the course of the project.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02380638

First Posted

February 20, 2015

Last Updated

February 27, 2015

Sponsor

Universidad de Zaragoza

1. Study Identification

Unique Protocol Identification Number

NCT02380638

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Zaragoza

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Down Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DS-WBV

Arm Type

Experimental

Arm Description

Arm Title

DS-NONWBV

Arm Type

No Intervention

Arm Description

This group will continue with their day-to-day lifestyle during the course of the project.

Arm Title

NONDS-WBV

Arm Type

Experimental

Arm Description

Arm Title

NONDS-NONWBV

Arm Type

No Intervention

Arm Description

This group will continue with their day-to-day lifestyle during the course of the project.

Intervention Type

Device

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José A. Casajús, MD, PhD

Organizational Affiliation

GENUD Research Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

GENUD Research Group

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

12. IPD Sharing Statement

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

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