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

May 27, 2015 updated by: Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School

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

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Erlangen, Germany, 91052
        • Institute of Medical Physics, University of Erlangen-Nurnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: 1
vertical vibration device (using Vibrafit whole body vibration platforms)
3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with vertical device
Active Comparator: 2
side-alternating vibration device (using Board 3000 whole body vibration platforms)
3 sessions/week 15 min each, leg exercises performed on whole body vibration platforms with side alternating device
Sham Comparator: 3
wellness-control group
2x10 weeks with 1 session/week of low volume, low intensity wellness training over 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone Mineral Density
Time Frame: Baseline, 12 months
Baseline, 12 months

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
daily over 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • OFZ-Elvis-II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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