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Effect of Whole Body Vibration on Bone and Fall Related Parameters

Primary Purpose

Atrophy

Status

Terminated

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

whole body vibration

resistance exercise

"wellness"

About this trial

This is an interventional prevention trial for Atrophy focused on measuring whole body vibration, exercise, elderly woman, Bone Mineral Density, falls, higher age

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: community living elderly females >/=65 years live expectation > 2 years Exclusion Criteria: secondary osteoporosis CVD-events including stroke participation in other studies medication and illness affecting bone metabolism within the last 2 years medication with impact on falls low physical performance (<50 Watt during ergometry) excessive alcohol-intake

Sites / Locations

Institute of Medical Physics

Outcomes

Primary Outcome Measures

BMD after 6, 12 and 18 months

strength

power

Secondary Outcome Measures

balance

bone markers

Full Information

NCT ID

NCT00292916

First Posted

February 15, 2006

Last Updated

May 27, 2015

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Institute of Biometrie and Medical Statistics, Netzwerk-Knochengesundheit, Siemens-Betriebskrankenkasse

1. Study Identification

Unique Protocol Identification Number

NCT00292916

Brief Title

Effect of Whole Body Vibration on Bone and Fall Related Parameters

Official Title

Effect of Whole Body Vibration on Bone and Fall Related Parameters - the Erlangen Longitudinal Vibration Study (ELVIS)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Terminated

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Institute of Biometrie and Medical Statistics, Netzwerk-Knochengesundheit, Siemens-Betriebskrankenkasse

4. Oversight

5. Study Description

Brief Summary

The effect of whole body vibration (WBV) on bone strength and fall frequency in older adults is still vague. Although there is some evidence that WBV may impact Bone Mineral Density in very frail elderly, there is a lack of data concerning the effect of WBV in community-living elderly woman. We hypothesize that WBV significantly affects bone parameters as assessed by DXA, QCT, US and bone markers with parallel positive changes of fall related risk factors (power, strength, balance, and reaction time). We further hypothesize that the effects of WBV were superior to conventional resistance exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrophy

Keywords

whole body vibration, exercise, elderly woman, Bone Mineral Density, falls, higher age

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

150 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

whole body vibration

Intervention Type

Behavioral

Intervention Name(s)

resistance exercise

Intervention Type

Behavioral

Intervention Name(s)

"wellness"

Primary Outcome Measure Information:

Title

BMD after 6, 12 and 18 months

Title

strength

Title

power

Secondary Outcome Measure Information:

Title

balance

Title

bone markers

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Willi A Kalender, PhD

Organizational Affiliation

University of Erlangen-Nürnberg Medical School

Official's Role

Study Chair

Facility Information:

Facility Name

Institute of Medical Physics

City

Erlangen

ZIP/Postal Code

91052

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

16307280

Citation

Kemmler W, Engelke K, Baumann H, Beeskow C, von Stengel S, Weineck J, Kalender WA. Bone status in elite male runners. Eur J Appl Physiol. 2006 Jan;96(1):78-85. doi: 10.1007/s00421-005-0060-1. Epub 2005 Oct 26.

Results Reference

background

PubMed Identifier

16096715

Citation

Engelke K, Kemmler W, Lauber D, Beeskow C, Pintag R, Kalender WA. Exercise maintains bone density at spine and hip EFOPS: a 3-year longitudinal study in early postmenopausal women. Osteoporos Int. 2006 Jan;17(1):133-42. doi: 10.1007/s00198-005-1938-9. Epub 2005 Aug 12.

Results Reference

background

PubMed Identifier

15746294

Citation

Stengel SV, Kemmler W, Pintag R, Beeskow C, Weineck J, Lauber D, Kalender WA, Engelke K. Power training is more effective than strength training for maintaining bone mineral density in postmenopausal women. J Appl Physiol (1985). 2005 Jul;99(1):181-8. doi: 10.1152/japplphysiol.01260.2004. Epub 2005 Mar 3.

Results Reference

background

PubMed Identifier

15615501

Citation

Kemmler W, Weineck J, Kalender WA, Engelke K. The effect of habitual physical activity, non-athletic exercise, muscle strength, and VO2max on bone mineral density is rather low in early postmenopausal osteopenic women. J Musculoskelet Neuronal Interact. 2004 Sep;4(3):325-34.

Results Reference

background

PubMed Identifier

20980923

Citation

Von Stengel S, Kemmler W, Bebenek M, Engelke K, Kalender WA. Effects of whole-body vibration training on different devices on bone mineral density. Med Sci Sports Exerc. 2011 Jun;43(6):1071-9. doi: 10.1249/MSS.0b013e318202f3d3.

Results Reference

derived

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Effect of Whole Body Vibration on Bone and Fall Related Parameters

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