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Effect of Whole Body Vibration on Bone and Fall Related Parameters

This study has been completed.
Sponsor:
Collaborators:
Institute of Biometrie and Medical Statistics
Netzwerk-Knochengesundheit
Siemens-Betriebskrankenkasse
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00292916
First received: February 15, 2006
Last updated: July 27, 2007
Last verified: July 2007
History of Changes
  Purpose

The effect of whole body vibration (WBV) on bone strength and fall frequency in older adults is still vague. Although there is some evidence that WBV may impact Bone Mineral Density in very frail elderly, there is a lack of data concerning the effect of WBV in community-living elderly woman. We hypothesize that WBV significantly affects bone parameters as assessed by DXA, QCT, US and bone markers with parallel positive changes of fall related risk factors (power, strength, balance, and reaction time). We further hypothesize that the effects of WBV were superior to conventional resistance exercise.


Condition Intervention Phase
Atrophy
 Behavioral: whole body vibration
Behavioral: resistance exercise
Behavioral: "wellness"
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Effect of Whole Body Vibration on Bone and Fall Related Parameters - the Erlangen Longitudinal Vibration Study (ELVIS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • BMD after 6, 12 and 18 months
  • strength
  • power

Secondary Outcome Measures:
  • balance
  • bone markers

Estimated Enrollment: 150
Study Start Date: January 2006
Estimated Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • community living elderly females >/=65 years
  • live expectation > 2 years

Exclusion Criteria:

  • secondary osteoporosis
  • CVD-events including stroke
  • participation in other studies
  • medication and illness affecting bone metabolism within the last 2 years
  • medication with impact on falls
  • low physical performance (<50 Watt during ergometry)
  • excessive alcohol-intake
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292916

Locations
Germany
Institute of Medical Physics
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg
Institute of Biometrie and Medical Statistics
Netzwerk-Knochengesundheit
Siemens-Betriebskrankenkasse
Investigators
Study Chair: Willi A Kalender, PhD University of Erlangen-Nürnberg Medical School
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00292916     History of Changes
Other Study ID Numbers: D-ER-OFZ-200501-Vib
Study First Received: February 15, 2006
Last Updated: July 27, 2007
Health Authority: Germany: Bayrisches Staatsministerium für Wissenschaft, Forschung und Kunst

Keywords provided by University of Erlangen-Nürnberg Medical School:
whole body vibration
exercise
elderly woman
 Bone Mineral Density
falls
higher age

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 17, 2013