Effect of Whole Body Vibration on Bone and Fall Related Parameters

Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00292916
• Other study ID #: D-ER-OFZ-200501-Vib
• Status: Terminated
• Phase: Phase 3
• First received: February 15, 2006
• Last updated: May 27, 2015
• Start date: January 2006
• Est. completion date: July 2007

Study information

• Verified date: May 2015
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bayrisches Staatsministerium für Wissenschaft, Forschung und Kunst
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrophy

Intervention

Behavioral:
• whole body vibration

• resistance exercise

• "wellness"

Locations

Country	Name	City	State
Germany	Institute of Medical Physics	Erlangen

Sponsors (4)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Institute of Biometrie and Medical Statistics, Netzwerk-Knochengesundheit, Siemens-Betriebskrankenkasse

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. Epub 2005 Aug 12. — View 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. Epub 2005 Oct 26. — View 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. — View 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. Epub 2005 Mar 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMD after 6, 12 and 18 months
Primary	strength
Primary	power
Secondary	balance
Secondary	bone markers