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Effect of Whole Body Vibration on Bone and Fall Related Parameters

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.
 
ClinicalTrials.gov Identifier: NCT00292916
Recruitment Status : Terminated
First Posted : February 16, 2006
Last Update Posted : May 28, 2015
Sponsor:
Collaborators:
Institute of Biometrie and Medical Statistics
Netzwerk-Knochengesundheit
Siemens-Betriebskrankenkasse
Information provided by (Responsible Party):
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Atrophy Behavioral: whole body vibration Behavioral: resistance exercise Behavioral: "wellness" Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
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)
Study Start Date : January 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. BMD after 6, 12 and 18 months
  2. strength
  3. power

Secondary Outcome Measures :
  1. balance
  2. bone markers

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
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
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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
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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
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Study Chair: Willi A Kalender, PhD University of Erlangen-Nürnberg Medical School
More Information
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Publications:

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

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Responsible Party: Wolfgang Kemmler, Principal Investigator, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00292916    
Other Study ID Numbers: D-ER-OFZ-200501-Vib
First Posted: February 16, 2006    Key Record Dates
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:
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Atrophy
Pathological Conditions, Anatomical