NCT03599934已完成不适用
The Effect of Lifestyle-integrated Functional Exercise Plus a Home Safety Visit on Reducing Falls in Community Older Fallers: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Fall
研究概览
简要总结
This proposed randomized controlled trial aims to study the long-term compliance of the LiFE program and its combined effects with a home safety visit on fall prevention in community-dwelling older fallers.
详细描述
This will be a single-blinded randomized controlled trial. The subjects will be randomly assigned to the LiFE exercise plus home safety assessment group, or the control group by a computer program operated by an independent researcher. This study conforms to the ethical principles of the World Medical Association Declaration of Helsinki.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 60 or older
- •able to ambulate with a Functional Ambulation Category (FAC) score ≥ 3
- •able to walk for ≥ 10 meters
- •history of falls in the past 12 months
- •living in the community
- •without MCI or dementia according to the 5-minute Montreal Cognitive assessment
- •have a moderate fall risk or above as assessed by the Physiological Profile Assessment
- •able to understand Chinese.
排除标准
- •blindness
- •diagnosis of mental disorders (e.g., severe depression, schizophrenia)
- •any contraindications to exercise (e.g. unstable angina).
结局指标
主要结局
Fall
时间窗: 1.5 years
Prospective fall data will be collected through telephone follow-up for 1.5 year
次要结局
- Montreal Cognitive Assessment 5-minute protocol(Baseline and follow-up assessment at 6-month)
- Handgrip strength(Baseline and follow-up assessment at 6-month)
- Activity level(Baseline and follow-up assessment at 6-month)
- Fall risk(Baseline and follow-up assessment at 6-month)
- Single leg standing balance(Baseline and follow-up assessment at 6-month)
- 10-meter walk test(Baseline and follow-up assessment at 6-month)
- Timed-up and Go test(Baseline and follow-up assessment at 6-month)
- Timed-up and Go test with dual-task(Baseline and follow-up assessment at 6-month)
- Functional lower body strength(Baseline and follow-up assessment at 6-month)
研究者
Timothy Kwok
Professor
Chinese University of Hong Kong
研究点 (2)
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