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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00667667
First Posted: April 28, 2008
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.
Collaborator:
Elsbeth-Bonhoff-Stiftung, Berlin
Information provided by (Responsible Party):
Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
  Purpose

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.


Condition Intervention Phase
Postmenopausal Device: vertical vibration device (Vibrafit whole body vibration platform) Device: side alternating vibration device (Board 3000 whole body vibration platform) Behavioral: stretching and wellness (control group) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Whole Body Vibration Training on Two Different Devices on Osteoporotic Risk Factors in Postmenopausal Women. A Randomized Controlled Trial.

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

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: Baseline, 12 months ]

Secondary Outcome Measures:
  • muscle strength [ Time Frame: baseline, 12 months ]
  • Quality of life [ Time Frame: baseline, 12 month ]
  • falls [ Time Frame: daily over 12 month ]

Enrollment: 108
Study Start Date: April 2008
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
vertical vibration device (using Vibrafit whole body vibration platforms)
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
Active Comparator: 2
side-alternating vibration device (using Board 3000 whole body vibration platforms)
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
Sham Comparator: 3
wellness-control group
Behavioral: stretching and wellness (control group)
2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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): NCT00667667


Locations
Germany
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Elsbeth-Bonhoff-Stiftung, Berlin
Investigators
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
  More Information