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.|
|ClinicalTrials.gov Identifier: NCT00973167|
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : April 24, 2012
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||704 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
No Intervention: Control
Remains sedentary with normal lifestyle
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
- Fracture rate [ Time Frame: up to 18 months ]
- Balancing ability [ Time Frame: up to 18 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00973167
|Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong|
|Hong Kong, China|
|Principal Investigator:||Kwok-Sui Leung, MD||Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong|