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

• Sponsor: University of Erlangen-Nürnberg Medical School (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00667667
• Collaborator: Elsbeth-Bonhoff-Stiftung, Berlin (Other)
• Enrollment: 108
• Location: 1
• Arms: 3
• Duration (Months): 19
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	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 Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• 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.
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Bone Mineral Density [Baseline, 12 months]

Secondary Outcome Measures

1. muscle strength [baseline, 12 months]

2. Quality of life [baseline, 12 month]

3. falls [daily over 12 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• homepage of the Institute of Medical Physics

Publications

• 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.
• 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.
• 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.

• Responsible Party: Wolfgang Kemmler, Principal Investigator, University of Erlangen-Nürnberg Medical School
• ClinicalTrials.gov Identifier: NCT00667667
• Other Study ID Numbers: OFZ-Elvis-II
• First Posted: Apr 28, 2008
• Last Update Posted: May 28, 2015
• Last Verified: May 1, 2015

• Keywords provided by Wolfgang Kemmler, Principal Investigator, University of Erlangen-Nürnberg Medical School: whole body vibration; exercise; postmenopausal; BMD; bone; elderly females; Caucasian race

Study Results

No Results Posted as of May 28, 2015