A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia
2016年5月5日 更新者：Dr. Chan Wai Chi、The University of Hong Kong
The study aims to compare the efficacy of a home-based structured exercise programme (12-step sitting Tai Chi) involving both persons with dementia and their caregivers with a standard non-exercise social contact control in treating depression among caregivers.
The effects of exercise on their cognition, quality of life and balance ability are also assessed.
We will also examine if BDNF polymorphisms modulate mood changes in response to exercise intervention.
Focus groups will be organised at the end to find out the facilitators and barriers in taking up exercise.
The findings may offer an avenue of intervention by providing a low cost, relatively safe and effective treatment for dementia caregivers, which may in turn benefit the persons with dementia.
研究概览
详细说明
The proposed study is a single-blind randomised controlled trial for two years. We will compare the efficacy of a home-based structured exercise programme (12-step sitting Tai Chi) for both carers and care recipients with a standard non-exercise social contact control in the treatment of depression among caregivers of persons with dementia. The study hypotheses include:
- The structured home-based exercise programme will reduce caregiver depression. (Primary outcome)
- The home-based exercise will improve caregivers' cognitive performance, quality of life and balance ability at the end of the study. (Secondary outcome)
- The home-based exercise will improve the cognitive performance, quality of life and balance ability of persons with dementia at the end of the study. (Secondary outcome)
- We also hypothesise that BDNF gene modulates mood changes in response to exercise intervention. (Secondary outcome)
研究类型
介入性
注册 (预期的)
272
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Hong Kong、中国
- 招聘中
- Hong Kong East Cluster, Hospital Authority
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首席研究员：
- Kong Hing Leung
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Hong Kong、中国
- 招聘中
- Hong Kong West Cluster, Hospital Authority
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接触：
- Wai Chi Chan
- 电话号码：(+852) 2255 4486
- 邮箱：waicchan@hku.hk
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首席研究员：
- Wai Chi Chan
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Hong Kong、中国
- 招聘中
- Kowloon West Cluster, Hospital Authority
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首席研究员：
- Karen Wat
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Hong Kong、中国
- 招聘中
- New Territories East Cluster, Hospital Authority
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首席研究员：
- Linda Lam
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Hong Kong、中国
- 完全的
- New Territories West Cluster, Hospital Authority
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Caregivers
- 18 years of age and above
- Live with persons with dementia
- 15-item Geriatric Depression Scale (GDS) >0 and <8
- No regular (i.e. ≥ 3 times/week) Tai Chi practice or other forms of mind-body exercise (e.g. yoga, qigong, mindfulness training) in the past six months
- Understand Chinese
- If they are on an antidepressant, they will not be included in the study unless they have been receiving pharmacological treatment on a steady dose for three months
Care recipient
- Aged 60 years or above
- Dementia diagnosis confirmed by a physician
- Dependence in at least one Activities of daily living(ADL)
- Mini Mental State Examination (MMSE) > 10
- No regular (i.e. ≥ 3 times/week) Tai Chi practice or other forms of mind-body exercise (e.g. yoga, qigong, mindfulness training) in the past six months
Exclusion Criteria:
Caregivers
- Presence of psychotic symptoms, imminently suicidal, unstable medical conditions (e.g. recent heart attack, recent stroke, episodes of dizziness, fainting attacks) or significant orthopaedic problems rendering participants unsuitable for physical training
- Carers who are found to have mental conditions that warrants psychiatric assessment and/or treatment (e.g. GDS >8, i.e. local cut-off score for significant depressive symptoms, or suicidal) will be referred to appropriate units for follow up
Care recipient
- Presence of psychotic symptoms, unstable medical conditions (e.g. recent heart attack, recent stroke, episodes of dizziness, fainting attacks) or significant orthopaedic problems rendering participants unsuitable for physical training
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：12-step sitting Tai Chi Chuan
The intervention is a simplified Tai Chi Chuan exercise, which consists of 12 steps, including weight shifting in different sitting positions, trunk and upper limb movements, and alternate thigh lift in a smooth and coordinated manner.
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The intervention consists of eight home-based sessions on 12-step sitting Tai Chi Chuan.
Each session will last for an hour.
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安慰剂比较：Control
We provide participants in the control group with a level of social contact equivalent to the intervention group, which comprises structured conversations on topic other than physical activity.
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The control consists of eight home-based sessions on useful health-care information.
Each session will last for an hour.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline Hamilton Rating Scale for Depression in caregivers
大体时间：Week 12
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The proportion of participants who are classified as responders by Hamilton Rating Scale for Depression (HAM-D-17).
HAM-D-17 is a widely used and reliable measure of depressive symptoms.
The scores range from 0 to 52, with higher scores indicating greater depression severity.
Response to intervention is defined as a reduction of HAM-D-17 total score by ≥50% from baseline to endpoint.
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Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Berg Balance Scale in caregivers and care recipients
大体时间：Week 12
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Berg Balance Scale (BBS)
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Week 12
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Mini Mental State Examination in caregivers and care recipients
大体时间：Week 12
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Global cognitive function will be measured by Mini Mental State examination (MMSE)
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Week 12
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Quality of life in caregivers and care recipients
大体时间：Week 12
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SF-12 Health Survey (SF-12)
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Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Wai Chi Chan、The University of Hong Kong
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年5月1日
初级完成 (预期的)
2016年9月1日
研究完成 (预期的)
2017年3月1日
研究注册日期
首次提交
2014年4月28日
首先提交符合 QC 标准的
2014年5月3日
首次发布 (估计)
2014年5月6日
研究记录更新
最后更新发布 (估计)
2016年5月6日
上次提交的符合 QC 标准的更新
2016年5月5日
最后验证
2016年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.