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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00973167
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : April 24, 2012
Information provided by (Responsible Party):
Kwok-Sui Leung, Chinese University of Hong Kong

Brief Summary:

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 or disease Intervention/treatment Phase
Fractures Device: Low-magnitude high-frequency vibration treatment Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 704 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Fracture rate [ Time Frame: up to 18 months ]

Secondary Outcome Measures :
  1. Balancing ability [ Time Frame: up to 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00973167

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Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Kwok-Sui Leung, MD Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kwok-Sui Leung, Chair Professor, Chinese University of Hong Kong Identifier: NCT00973167    
Other Study ID Numbers: 469508
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012
Keywords provided by Kwok-Sui Leung, Chinese University of Hong Kong:
Fracture rate
Fracture risks
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries