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Effect of Whole Body Vibration on Bone and Fall Related Parameters

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292916
First Posted: February 16, 2006
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Institute of Biometrie and Medical Statistics
Netzwerk-Knochengesundheit
Siemens-Betriebskrankenkasse
Information provided by (Responsible Party):
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
  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
Intervention Model: Parallel Assignment
Masking: Single
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:


Further study details as provided by Wolfgang Kemmler, 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
Study Completion Date: July 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes 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
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): NCT00292916


Locations
Germany
Institute of Medical Physics
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wolfgang Kemmler, Principal Investigator, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00292916     History of Changes
Other Study ID Numbers: D-ER-OFZ-200501-Vib
First Submitted: February 15, 2006
First Posted: February 16, 2006
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Wolfgang Kemmler, 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