Acute and Chronic Effects of Whole-body Vibration on Mobility, Muscle Strength, Bone and General Health Status in the Frail Elderly
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change of general health status (SF-12 score) from Baseline to 6 month post-WBV
研究概览
简要总结
Objective: To study the acute and chronic effects of whole-body vibration (WBV) exercises on the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status, and its feasibility as an intervention in frail elderly patients.
Design: Randomized controlled trial. Subjects: The frail older persons meeting the Fried Frailty Criteria.
Interventions: All eligible subjects were randomly assigned to 4 groups:
(1) WBV group: Subjects received a whole-body vibration exercise alone; (2) Progressive resistance training (PRT) group: Subjects received progressive resistance training; (3) WBV+ PRT group: Subjects received the whole-body vibration and progressive resistance training; (4) Control group: Subjects received no intervention/training. The periods of intervention are 12 weeks.
Main measures: The lower extremities blood flow (the diameters and red blood cell velocity of the common femoral artery), timed up and go test, 30-second chair stand test, five times sit to stand test, lower extremities muscle strength, balance function, balance confidence, bone density, and general health status was assessed at the beginning of the study, at instant, 12 weeks and 24 month after the intervention.
Study hypothesis: Whole-body vibration exercise is a safe and effective method that can improve the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status in the frail 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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥75 years old
- •Fried Frailty Criteria
- •Mini Mental State Examination score ≥18
排除标准
- •Recent fractures (≤6 months)
- •Gallbladder or kidney stones
- •Malignancies
- •Rheumatic arthritis
- •Serious heart sicknesses or an implant, and bypass stent or cardiac pacemaker
- •Any diseases to be associated with a life expectancy of less than 12 months
结局指标
主要结局
Change of general health status (SF-12 score) from Baseline to 6 month post-WBV
时间窗: 6 month post-WBV
Change of the common femoral artery's blood flow from Baseline to 60min post-WBV
时间窗: 60min post-WBV
Change of lower extremities muscle strength from Baseline to 3 month post-WBV
时间窗: 3 month post-WBV
Change of "timed up and go" test (TUGT) from Baseline to 3 month post-WBV
时间窗: 3 month post-WBV
Change of 30-second chair stand test from Baseline to 3 month post-WBV
时间窗: 3 month post-WBV
Change of balance function from Baseline to 3 month post-WBV
时间窗: 3 month post-WBV
Change of balance confidence from Baseline to 3 month post-WBV
时间窗: 3 month post-WBV
Change of bone density from Baseline to 6 month post-WBV
时间窗: 6 month post-WBV
次要结局
未报告次要终点
研究者
Li Zhang
Doctor
Chinese PLA General Hospital