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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Fractures
 Device: Low-magnitude high-frequency vibration treatment
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Low-magnitude, High-frequency Vibration Treatment on Reducing Fracture Risks and Fracture Incidences in the Community Elderly - a Prospective Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Fracture rate [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Balancing ability [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]

Enrollment: 704
Study Start Date: January 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Remains sedentary with normal lifestyle
Experimental: Treatment
Receive LMHFV treatment for 18 months.
 Device: Low-magnitude high-frequency vibration treatment
Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5 days/week

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973167

Locations
China
Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Kwok-Sui Leung, MD Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Kwok-Sui Leung, Chair Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00973167     History of Changes
Other Study ID Numbers: 469508
Study First Received: August 5, 2009
Last Updated: April 23, 2012
Health Authority: Hong Kong: Department of Health
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Fracture rate
Fracture risks

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013