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

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ClinicalTrials.gov Identifier: NCT02380638
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
José A. Casajús, Universidad de Zaragoza

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. Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

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.



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. [ Time Frame: 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. [ Time Frame: Changes from baseline in bone structure at 6 months and changes from baseline in bone structure at 15 months ]


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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380638


Locations
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Spain
GENUD Research Group
Zaragoza, Spain, 50009
Sponsors and Collaborators
Universidad de Zaragoza
Investigators
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Principal Investigator: José A. Casajús, MD, PhD GENUD Research Group

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Responsible Party: José A. Casajús, MD, PhD., Universidad de Zaragoza
ClinicalTrials.gov Identifier: NCT02380638     History of Changes
Other Study ID Numbers: DEP2009-09183
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn