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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postmenopausal

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>vertical vibration device (using Vibrafit whole body vibration platforms) | Device: vertical vibration device (Vibrafit whole body vibration platform)<br>* 3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with vertical device<br>|
| Active Comparator: 2<br>side-alternating vibration device (using Board 3000 whole body vibration platforms) | Device: side alternating vibration device (Board 3000 whole body vibration platform)<br>* 3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with side alternating device<br>|
| Sham Comparator: 3<br>wellness-control group | Behavioral: stretching and wellness (control group)<br>* 2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density |  | Baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength |  | baseline, 12 months | 
| Quality of life |  | baseline, 12 month | 
| falls |  | daily over 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whole body vibration, exercise, postmenopausal, BMD, bone, elderly females, Caucasian race