- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00667667
Effects of Whole Body Vibration on Postmenopausal Risk-factors in Elderly Women
Effect of Whole Body Vibration Training on Two Different Devices on Osteoporotic Risk Factors in Postmenopausal Women. A Randomized Controlled Trial.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Erlangen, Germany, 91052
- Institute of Medical Physics, University of Erlangen-Nurnberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 1
vertical vibration device (using Vibrafit whole body vibration platforms)
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3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with vertical device
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Active Comparator: 2
side-alternating vibration device (using Board 3000 whole body vibration platforms)
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3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with side alternating device
|
|
Sham Comparator: 3
wellness-control group
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2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Bone Mineral Density
Time Frame: Baseline, 12 months
|
Baseline, 12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
muscle strength
Time Frame: baseline, 12 months
|
baseline, 12 months
|
|
Quality of life
Time Frame: baseline, 12 month
|
baseline, 12 month
|
|
falls
Time Frame: daily over 12 month
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daily over 12 month
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Collaborators and Investigators
Collaborators
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
Publications and helpful links
General 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. doi: 10.1001/archinte.164.10.1084.
- 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. doi: 10.1136/bjsm.2006.033480. 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 (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OFZ-Elvis-II
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