跳至主要内容
临床试验/NCT00973167
NCT00973167已完成2 期

The Efficacy of Low-magnitude, High-frequency Vibration Treatment on Reducing Fracture Risks and Fracture Incidences in the Community Elderly - a Prospective Randomized Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 704 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
704
试验地点
1
主要终点
Fracture rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Fracture rate

时间窗: up to 18 months

次要结局

  • Balancing ability(up to 18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kwok-Sui Leung

Chair Professor

Chinese University of Hong Kong

研究点 (1)

Loading locations...

相似试验

Low-magnitude High-frequency Vibration Study on... | 临床试验