NCT06378164Unknown不适用
The Immediate and Sustained Effect of 4-week Combined Volitional and Reactive Step Training in Reducing Falls Risk in Community-Dwelling Older Fallers: a Randomised Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Choice Stepping Reaction Times
研究概览
简要总结
To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling
- •Able to walk for 1 minute under supervision without walking aids
- •Have a history of falling in the past year
排除标准
- •Cognitive impairment (i.e., scores below the age and education-specific cut-off of 7th percentile in the 5-minute Montreal cognitive assessment)
- •Blindness
- •Neurological conditions (e.g., stroke, Parkinson's disease)
- •Other serious illnesses that preclude participation in exercise training
研究组 & 干预措施
Non-specific exercise group
Placebo Comparator
干预措施: Active Control (Behavioral)
Combined volitional and reactive step training
Experimental
干预措施: Exercise (Behavioral)
结局指标
主要结局
Choice Stepping Reaction Times
时间窗: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
To assess volitional stepping performance
Spring Scale Test
时间窗: (i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention
To assess reactive stepping performance
次要结局
- Falls Efficacy Scale - International((i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention)
- Trail-Making Test((i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention)
- Prospective Falls(From start to 12 months after the intervention ends)
- Mini Balance Evaluation System Test((i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention)
- Motor Control Test((i) baseline, (ii) immediately post-intervention, (iii) 3-months post-intervention and (iv) 6-months post-intervention)
- Programme Adherence(From start to six months after the end of training)
- Adverse Events(From start to six months after the end of training)
研究者
Freddy Man Hin LAM
Assistant Professor
The Hong Kong Polytechnic University
研究点 (1)
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