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临床试验/NCT06378164
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

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2023年12月1日最近更新:
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

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

Freddy Man Hin LAM

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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