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Effect of Whole Body Vibration on Bone and Fall Related Parameters

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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

Tracking Information
First Submitted Date  ICMJE February 15, 2006
First Posted Date  ICMJE February 16, 2006
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2006)
  • BMD after 6, 12 and 18 months
  • strength
  • power
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2006)
  • BMD after 12 and 18 months
  • strength
  • power
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2006)
  • balance
  • bone markers
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Whole Body Vibration on Bone and Fall Related Parameters
Official Title  ICMJE Effect of Whole Body Vibration on Bone and Fall Related Parameters - the Erlangen Longitudinal Vibration Study (ELVIS)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Condition  ICMJE Atrophy
Intervention  ICMJE
  • Behavioral: whole body vibration
  • Behavioral: resistance exercise
  • Behavioral: "wellness"
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: February 15, 2006)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00292916
Other Study ID Numbers  ICMJE D-ER-OFZ-200501-Vib
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Erlangen-Nürnberg Medical School
Original Study Sponsor  ICMJE University of Erlangen-Nürnberg
Collaborators  ICMJE
  • Institute of Biometrie and Medical Statistics
  • Netzwerk-Knochengesundheit
  • Siemens-Betriebskrankenkasse
Investigators  ICMJE
Study Chair: Willi A Kalender, PhD University of Erlangen-Nürnberg Medical School
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP