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

Phase 3

Terminated

• Conditions: Postmenopausal
• Interventions: 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)

• Registration Number: NCT00667667
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-28
• Primary Completion: 2009-06
• Study Completion: 2009-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	vertical vibration device (Vibrafit whole body vibration platform)	vertical vibration device (using Vibrafit whole body vibration platforms)
2	side alternating vibration device (Board 3000 whole body vibration platform)	side-alternating vibration device (using Board 3000 whole body vibration platforms)
3	stretching and wellness (control group)	wellness-control group

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density	Baseline, 12 months

Secondary Outcome Measures

Name	Time	Method
muscle strength	baseline, 12 months
Quality of life	baseline, 12 month
falls	daily over 12 month

Trial Locations

Locations (1)

Institute of Medical Physics, University of Erlangen-Nurnberg; 🇩🇪 Erlangen, Germany