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

University of Erlangen-Nürnberg Medical School

Status and phase: Terminated; Phase 3

Conditions: Postmenopausal

Treatments: Behavioral: stretching and wellness (control group); Device: side alternating vibration device (Board 3000 whole body vibration platform); Device: vertical vibration device (Vibrafit whole body vibration platform)

Study type: Interventional

Funder types: Other

Identifiers

NCT00667667

OFZ-Elvis-II

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: Female

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

1

Active Comparator group

Description:

vertical vibration device (using Vibrafit whole body vibration platforms)

Treatment:

Device: vertical vibration device (Vibrafit whole body vibration platform)

2

Active Comparator group

Description:

side-alternating vibration device (using Board 3000 whole body vibration platforms)

Treatment:

Device: side alternating vibration device (Board 3000 whole body vibration platform)

3

Sham Comparator group

Description:

wellness-control group

Treatment:

Behavioral: stretching and wellness (control group)