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"
Sponsored by
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
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
Accepts Healthy Volunteers
Eligibility Criteria
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
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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