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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Down Syndrome

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DS-WBV<br>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.<br> <br> |
| No Intervention: DS-NONWBV<br>This group will continue with their day-to-day lifestyle during the course of the project. | |
| Experimental: NONDS-WBV<br>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.<br> <br> |
| No Intervention: NONDS-NONWBV<br>This group will continue with their day-to-day lifestyle during the course of the project. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |