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Effects of Whole Body Vibration on Postmenopausal Risk-factors in Elderly Women

This study has been completed.
Sponsor:
Collaborator:
Elsbeth-Bonhoff-Stiftung, Berlin
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00667667
First received: April 24, 2008
Last updated: December 3, 2009
Last verified: December 2009

April 24, 2008
December 3, 2009
April 2008
June 2009   (final data collection date for primary outcome measure)
Bone Mineral Density [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00667667 on ClinicalTrials.gov Archive Site
  • muscle strength [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: baseline, 12 month ] [ Designated as safety issue: No ]
  • falls [ Time Frame: daily over 12 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Whole Body Vibration on Postmenopausal Risk-factors in Elderly Women
Effect of Whole Body Vibration Training on Two Different Devices on Osteoporotic Risk Factors in Postmenopausal Women. A Randomized Controlled Trial.

There is general agreement that physical exercise can positively influence osteoporotic fracture risk along two pathways: first by reducing the risk of falls via an improvement of fall related neuromuscular abilities; second by increasing bone strength.

Whole body vibration (WBV) training has recently been proposed as a new approach for prevention and treatment of osteoporosis. Animal studies have shown evidence that WBV may be an effective method to improve bone mass, architecture and strength. However, the results of human WBV training studies are rather heterogeneous.

In the Erlangen Longitudinal Vibration Study II (ELVIS II), a randomized, controlled 12 month lasting study the investigators determine the effect of a thrice weekly WBV training on two different devices on the osteoporotic risk factors: bone mineral density, falls and neuromuscular performance. Particular the investigators compare a bipedal vertical oscillating Plate with a plate which rotates around a central axis leading to a side-alternating loaning.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Postmenopausal
  • Device: vertical vibration device (Vibrafit whole body vibration platform)
    3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with vertical device
  • Device: side alternating vibration device (Board 3000 whole body vibration platform)
    3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with side alternating device
  • Behavioral: stretching and wellness (control group)
    2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months
  • Active Comparator: 1
    vertical vibration device (using Vibrafit whole body vibration platforms)
    Intervention: Device: vertical vibration device (Vibrafit whole body vibration platform)
  • Active Comparator: 2
    side-alternating vibration device (using Board 3000 whole body vibration platforms)
    Intervention: Device: side alternating vibration device (Board 3000 whole body vibration platform)
  • Sham Comparator: 3
    wellness-control group
    Intervention: Behavioral: stretching and wellness (control group)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
November 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • females 60 - 75 years old
  • caucasian race

Exclusion Criteria:

  • CHD-diseases
  • thrombosis, embolism
  • fractures at lumbar spine or hip
  • secondary osteoporosis
  • hyperparathyroidism
  • medication, diseases with impact on muscle or bone
  • hip or knee implant
Female
60 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00667667
OFZ-Elvis-II
No
Simon von Stengel, Institute of Medical Physics
University of Erlangen-Nürnberg
Elsbeth-Bonhoff-Stiftung, Berlin
Principal Investigator: Simon O von Stengel, PhD University of Erlangen-Nürnberg Medical School
Study Chair: Wolfgang K Kemmler, PhD Instiute of Medical Physics
Study Director: Willi A Kalender, Prof., PhD University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
December 2009

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