Fractures Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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