Effects of Whole Body Vibration on Postmenopausal Risk-Factors in Elderly Women - Full Text View

Sponsors and Collaborators:	University of Erlangen-Nürnberg Elsbeth-Bonhoff-Stiftung, Berlin
Information provided by:	University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier:	NCT00667667

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 we 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 we 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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Exercise and Physical Fitness Minerals

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	108
Study Start Date:	April 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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
3: Sham Comparator 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

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
Study Chair:	Wolfgang K Kemmler, PhD	Instiute of Medical Physics
Study Director:	Willi A Kalender, Prof., PhD	University of Erlangen-Nürnberg

More Information

Additional Information:

homepage of the Institute of Medical Physics This link exits the ClinicalTrials.gov site

Publications:

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.

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. 2005 Jul;99(1):181-8. Epub 2005 Mar 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.

Responsible Party:	Institute of Medical Physics ( Simon von Stengel )
Study ID Numbers:	OFZ-Elvis-II
Study First Received:	April 24, 2008
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00667667 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Germany: Federal Ministry of Education and Research

Keywords provided by University of Erlangen-Nürnberg:

whole body vibration
exercise
postmenopausal
BMD

bone
elderly females
Caucasian race

ClinicalTrials.gov processed this record on September 02, 2009