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Clinical Trials/NCT02380638
NCT02380638
Completed
N/A

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

Universidad de Zaragoza1 site in 1 country58 target enrollmentJanuary 2010
ConditionsDown Syndrome

Overview

Phase
N/A
Intervention
Not specified
Conditions
Down Syndrome
Sponsor
Universidad de Zaragoza
Enrollment
58
Locations
1
Primary Endpoint
Changes from baseline in body composition assessed with dual energy X-ray at different time points, 6 months and 15 months.
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
December 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

José A. Casajús

MD, PhD.

Universidad de Zaragoza

Eligibility Criteria

Inclusion Criteria

  • Both groups: Ages 10 -
  • 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.

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Study Sites (1)

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