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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   60 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667667

Locations
Germany
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, Germany, 91052
Sponsors and Collaborators
University of Erlangen-Nürnberg
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

Additional Information:
Publications:
Responsible Party: Simon von Stengel, Institute of Medical Physics
ClinicalTrials.gov Identifier: NCT00667667     History of Changes
Other Study ID Numbers: OFZ-Elvis-II
Study First Received: April 24, 2008
Last Updated: December 3, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research

Keywords provided by University of Erlangen-Nürnberg Medical School:
whole body vibration
exercise
postmenopausal
BMD
bone
elderly females
Caucasian race

ClinicalTrials.gov processed this record on July 22, 2014