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

Postmenopausal Clinical Trial

Official title:

Effect of Whole Body Vibration Training on Two Different Devices on Osteoporotic Risk Factors in Postmenopausal Women. A Randomized Controlled Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00667667
• Other study ID #: OFZ-Elvis-II
• Status: Terminated
• Phase: Phase 3
• First received: April 24, 2008
• Last updated: May 27, 2015
• Start date: April 2008
• Est. completion date: November 2009

Study information

• Verified date: May 2015
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: November 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postmenopausal

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Institute of Medical Physics, University of Erlangen-Nurnberg	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Elsbeth-Bonhoff-Stiftung, Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Kemmler W, Lauber D, Weineck J, Hensen J, Kalender W, Engelke K. Benefits of 2 years of intense exercise on bone density, physical fitness, and blood lipids in early postmenopausal osteopenic women: results of the Erlangen Fitness Osteoporosis Prevention Study (EFOPS). Arch Intern Med. 2004 May 24;164(10):1084-91. — View Citation

Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. Epub 2005 Mar 3. — View Citation

von Stengel S, Kemmler W, Kalender WA, Engelke K, Lauber D. Differential effects of strength versus power training on bone mineral density in postmenopausal women: a 2-year longitudinal study. Br J Sports Med. 2007 Oct;41(10):649-55; discussion 655. Epub 2007 Jun 5. Erratum in: Br J Sports Med. 2007 Dec;41(12):926. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density		Baseline, 12 months	No
Secondary	muscle strength		baseline, 12 months	No
Secondary	Quality of life		baseline, 12 month	No
Secondary	falls		daily over 12 month	No

External Links

•   homepage of the Institute of Medical Physics