Low-magnitude High-frequency Vibration Study on Fracture Rate in Community Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kwok-Sui Leung, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00973167
First received: August 5, 2009
Last updated: April 23, 2012
Last verified: April 2012

August 5, 2009
April 23, 2012
January 2009
April 2012   (final data collection date for primary outcome measure)
Fracture rate [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
Fracture rate [ Time Frame: A study period of 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00973167 on ClinicalTrials.gov Archive Site
Balancing ability [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
Balancing ability [ Time Frame: Baseline, 9 months and 18 months post-treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Low-magnitude High-frequency Vibration Study on Fracture Rate in Community Elderly
The Efficacy of Low-magnitude, High-frequency Vibration Treatment on Reducing Fracture Risks and Fracture Incidences in the Community Elderly - a Prospective Randomized Trial

Fragility fracture is common due to global aging problem, incurring huge healthcare expenditure. The occurrence of fragility fracture is usually caused by a fall incidence of an elderly with low bone quality and poor balancing ability. Therefore, any approach to improve or retard both sarcopenia and osteoporosis will be helpful to prevent osteoporotic fracture incidence. With the intensive research on low magnitude high frequency vibration (LMHFV), many scientific evidences support the application of this biophysical modality on elderly to maintain or improve the musculoskeletal tissues in elderly.

Many previous studies showed the osteogenic properties of vibration treatment and its positive effects on muscular performance and blood circulation. The investigators' previous reports also indicated that LMHFV could enhance the bone quality in spine and tibia in elderly after one-year intervention, as well as the balancing ability with high compliance. In animal studies, the application of LMHFV on fracture healing also demonstrated the significant acceleration of healing by inducing callus formation and maturation, from which upregulation of collagen I, II and BMP-2 gene expression was detected at molecular level. To date, the long-term efficacy of LMHFV on reducing fracture risks and fracture rate is, however, not available, which needs a systematic large-scale study to answer this important research question.

Therefore, the hypothesis of this study is that LMHFV can maintain or enhance the performance of various tissues of the musculoskeletal system in community elderly, thus reducing the fracture risks and fracture rate. A large-scale prospective randomized clinical trial will be conducted in multiple communities to investigate the long-term effect of LMHFV on fracture rate and reduction of fracture risks in community elderly, in which multi-factorial effects, in terms of muscle and bone, on musculoskeletal system will also be evaluated. A total of 704 elderly from 28 community centres will be recruited within 1.5-year time for a 18-month LMHFV treatment, who will be assessed on the fracture risks at fixed time points while their fracture rates on the third year of this study will be regarded as primary outcome for analysis. The findings of this study will provide very useful scientific data to support the application of LMHFV for elderly. The ultimate goal is to reduce the fracture rate and the quality of life of community-living elderly.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Fractures
Device: Low-magnitude high-frequency vibration treatment
Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5 days/week
  • No Intervention: Control
    Remains sedentary with normal lifestyle
  • Experimental: Treatment
    Receive LMHFV treatment for 18 months.
    Intervention: Device: Low-magnitude high-frequency vibration treatment
Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
704
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 65 years old or above
  • independent in accessing the centres

Exclusion Criteria:

  • having habitual exercise or participate in supervised exercise
  • having drug treatment that affects normal metabolism of musculoskeletal system
  • having hypo- or hyperparathyroidism, renal, liver or other chronic diseases
  • having low-energy fracture history
  • previous or current smokers or drinkers
Female
65 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00973167
469508
No
Kwok-Sui Leung, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Kwok-Sui Leung, MD Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong
Chinese University of Hong Kong
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP