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Completed

NCT Number: NCT02380638

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

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GENUD Research Group

Zaragoza, 50009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2015
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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