The Effects of Tai Chi on Cognition and Instrumental Activities of Daily Living, and Health Related Quality of Life in Older People With Mild Cognitive Impairment .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change from baseline C-MMSE score at four months
研究概览
简要总结
The prevalence of older people with cognitive decline is increasing since the aging population is growing substantially worldwide. Cognitive impairment places older adults at high risk for functional disability. Previous researches have provided strong evidence on the beneficial effects of physical exercise on maintaining cognitive functions in older adults. Tai Chi is considered as a low to moderate intensity exercise, which is performed in a slow and rhythmic movement. It is a popular and safe exercise suitable for older people who have weaker muscle strength. The aim of this study was to determine the effects of Tai Chi on cognition and instrumental activities of daily living (I-ADLs), and health-related quality of life (HRQOL) in older Chinese adults with mild cognitive impairment (MCI).
The research hypothesis of the study stated: There is significant improvement in the general cognitive performance, functional capabilities of instrumental ADLs,the physical component and mental component of HRQOL between the group of community-dwelling older people with MCI who have participated and the control group who have not participated in the Tai Chi program.
详细描述
- Study design & sample recruitment:
This was a quasi-experimental study which adopted the multi-site non-randomized control group pre- and post-test design. By adopting the multi-site design, better representation of the population could be obtained. This intervention study involved two groups of participant, the experimental and control groups, whereas no randomization would be taken place.
The study was carried out in District Elderly Community Centers (DECCs) in Hong Kong. The DECC has been implemented since 2001 under the support from the Social Warfare Department (SWD) to provide community support services at district level to enable older people to remain in the community and to lead a healthy, respectful and dignified life.The service users are community-dwelling older citizens aged 60 or above living in the locality. Invitation letters were sent to various DECCs for joining the study. Finally, there were four elderly centers willing to participate in the study. The participants were recruited from the four DECCs using convenience sampling.
To avoid the possible diffusion effect that might interfere the research result, all eligible participants in a community center were allocated to either experimental group or control group, who were treated with single intervention, so there would be no discussion among participants who have received different treatment regimes.
The present study had employed a control group to enhance methodological rigor and included a pre-test to assess the equivalence between two groups, so the problem on selection biases could be alleviated. 2. Sample size estimation A medium effect size of 0.5 was set for the study, based on previous research on the effect of Tai Chi on cognitive function. Based on the use of a sample size calculator (https://www2.ccrb.cuhk.edu.hk/stat/Other.htm), a sample of 64 per group was expected to provide 80% power to detect a medium effect size of 0.5, at a significance level of 0.05. Allowing for an attrition rate of 20% in the Tai Chi groups, 80 participants were recruited for each group. 3. Intervention The intervention group received a 16-week Tai Chi program, of 32 sessions (two sessions per week) each one hour long.The capacity was around 20 people per class. A certified Tai Chi master taught the Yang-style simple form of Tai Chi to the participants allocated to the experimental group.There were four sets of movements included in the simplified form; this required less time for the older practitioners, who usually had less exercise endurance, to complete the whole set of movements. Moreover, it was an appropriate form of Tai Chi for older people with MCI because it involved only a few postures, hence it was easier for them to learn and remember. The Tai Chi classes were conducted in the open hall of the community center or a public playground with sufficient space, a flat floor and good lighting.To promote safety, measures include appropriate footwear, appropriate warm-up and cool-down, correct exercise technique and gradual increases in exercise dose will be emphasized in Tai Chi class. Incident report will be done to record and analyses causes for any adverse effect on Tai Chi training.To ensure adherence, the participants were required to sign attendance records. Telephone follow-up was arranged to provide emotional support and reinforce compliance if they were absent from two consecutive lessons. As well, the participants were advised to do daily practice at home to foster better mastery of the Tai Chi movements and build up a regular exercise habit. A guide book was issued to each participant, providing guidance to reinforce correct postures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
All personals involved the study (participants, community center supporting staff, investigators and outcome assessors) had not masked for treatment assignment.
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese people aged 60 years or above;
- •Obtained the CMMSE screening score ranging from 19 to 28, which was corrected based on educational level (≥ 18 for illiterate respondents and ≥ 22 for those having received more than two years of education);
- •Have ability to perform self-care functions on their own;
- •No confirmed diagnosis of dementia, depression or other psychiatric illnesses;
- •Not engaged in any structured physical exercise program or Tai Chi practice in the preceding year.
排除标准
- •Had a medical history of chronic alcoholism or brain trauma occurred in previous years; - Regular users of medications that could affect cognition;
- •Contraindicated light to moderate physical exercise.
研究组 & 干预措施
Tai Chi group
The Tai Chi group (i.e. the intervention group) received a 16-week Tai Chi program, of 32 sessions (2 sessions per week), each being one hour long.
干预措施: Tai Chi (Behavioral)
Ususal care group
The control group received the usual care offered by the respective centers. No intervention had been arranged for the control group during the study period. Participants in the control group were advised to attend different kinds of recreational activities provided by their community centers and to continue with their daily activities, including their usual general physical mobility and social activities.
结局指标
主要结局
Change from baseline C-MMSE score at four months
时间窗: he outcome assessment was conducted at baseline, and at 4 month (at the end of study)
The Chinese version of Mini-Mental State Examination (C-MMSE) is a global cognitive assessment tool.The first part of the CMMSE assesses respondent's abilities on orientation, memory and attention and the second part tests respondent's ability to name objects, understanding on verbal and written commands; higher score indicates for better cognitive performance.
次要结局
- Change from baseline IADL-CV score at four months(The outcome assessment was conducted at baseline, and at 4 month (at the end of study))
- Change from baseline SF-12 score at four months(The outcome assessment was conducted at baseline, and at 4 month (at the end of study))
研究者
Minnie Siu
Principal Investigator
Chinese University of Hong Kong
