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Clinical Trials/NCT00667667
NCT00667667
Terminated
Phase 3

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

University of Erlangen-Nürnberg Medical School1 site in 1 country108 target enrollmentStarted: April 2008Last updated:
ConditionsPostmenopausal

Overview

Phase
Phase 3
Status
Terminated
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
108
Locations
1
Primary Endpoint
Bone Mineral Density

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
60 Years to 75 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Bone Mineral Density

Time Frame: Baseline, 12 months

Secondary Outcomes

  • Quality of life(baseline, 12 month)
  • falls(daily over 12 month)
  • muscle strength(baseline, 12 months)

Investigators

Sponsor
University of Erlangen-Nürnberg Medical School
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wolfgang Kemmler

Principal Investigator

University of Erlangen-Nürnberg Medical School

Study Sites (1)

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