Efficacy of Tai Chi Chuan on Cognitive Function in Type 2 Diabetes Mellitus Patients Accompanied With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Global cognition-Montreal Cognitive Assessment at 36 Weeks
研究概览
简要总结
The patients with type 2 diabetes mellitus (T2DM) is expected to rise to 439 million in 2030, accounting for 7.7% the population in the world. There are nearly 10 million T2DM patients with mild cognitive impairment (MCI) among people over 65 years old , accounting for about 8% of the people over 65 years old in China. The medical cost for patients with T2DM/MCI is 2.5 to 4 times higher than those without T2DM. And T2DM will increase the risk of cognitive impairment, and lead to various complications which will bring serious social and medical economic burden.
详细描述
It is critically important to identify effective treatments to enhance functional status of T2DM/MCI patients. Exercise has been shown to be beneficial for T2DM/MCI patients. As a Chinese traditional mind-body exercise that consists of both physical and mediation components, Tai Chi Chuan has been proved to be helpful in global cognition, memory, executive function and attention of MCI, and blood sugar of T2DM. However, the evidence of the effect of Tai Chi Chuan on T2DM/MCI patients is limited. The purpose of this study is to explore the effect of Tai Chi Chuan treating T2DM/MCI patients in cognitive function, balance, motor and sensation function, blood sugar, biochemistry profile and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •clinician diagnosis of T2DM;
- •presence of mild cognitive impairment, not demented;
- •age ≥ 60 years old;
- •did not engage in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time);
- •informed consent and voluntary participation.
排除标准
- •cognitive impairment caused by other reasons, taking drugs, poisoning, etc;
- •presence of medical conditions that unable or unsafe to exercise, such as depression symptoms, uncontrolled hypertension/ blood pressure/ blood glucose, nervous system diseases(stroke, Parkinson's disease, etc), musculoskeletal system diseases(arthritis, history of hip and/or knee joint replacement, etc), etc;
- •participating in other experiments that influence this study.
研究组 & 干预措施
Tai Chi Chuan Group
In addition to conventional medical treatment, participants will receive 3 sessions of 1-hour Tai Chi Chuan training per week for 24 weeks and standard diabetic care education.
干预措施: Tai Chi Chuan (Behavioral)
Fitness Walking Group
In addition to conventional medical treatment, participants will receive 3 sessions of 1-hour fitness walking training per week for 24 weeks and standard diabetic care education
干预措施: Fitness Walking (Behavioral)
Control group
In addition to conventional medical treatment, participants will receive standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.
干预措施: Standard Diabetic Care Education (Behavioral)
结局指标
主要结局
Global cognition-Montreal Cognitive Assessment at 36 Weeks
时间窗: 36 weeks (post-intervention follow-up)
Montreal Cognitive Assessment
次要结局
- Grip strength at 24, 36 weeks(24, 36 weeks)
- Memory function-Wechsler Memory Scale at 24, 36 Weeks(24, 36 weeks)
- Trial Making Test part B at 24, 36 weeks(24, 36 weeks)
- Digital Symbol test at 24, 36 weeks(24, 36 weeks)
- Global cognition-Montreal Cognitive Assessment at 24 weeks(24 weeks (post-intervention))
- Stroop color word test at 24, 36 weeks(24, 36 weeks)
- Boston naming test at 24, 36 weeks(24, 36 weeks)
- Multi-task balance test: Time up and go test; Time up and go test + cognitive task;Time up and go test + motor task;Time up and go test + cognitive task + motor task at 24, 36 weeks(24, 36 weeks)
- Functional reach test at 24, 36 weeks(24, 36 weeks)
- Sensation function at 24, 36 weeks(24, 36 weeks)
- Fall efficiency-Modified Falls Efficacy Scale at 24, 36 weeks(24, 36 weeks)
- Rey-Osterrieth complex graphics test at 24, 36 weeks(24, 36 weeks)
- One leg stance test at 24, 36 weeks(24, 36 weeks)
- Five times sit-to-stand test at 24, 36 weeks(24, 36 weeks)
- Quality of life-Medical Outcomes Study 36-item Short-Form Health Survey at 24, 36 weeks(24, 36 weeks)
研究者
Jing Tao
PhD
Fujian University of Traditional Chinese Medicine