Study of School and Graduate Institute of Physical Therapy College of Medicine in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- General cognitive function
研究概览
简要总结
Background: Promotion of cognitive functions of middle aged and older adults and prevention of dementia are important issues in the aging society. In recent years, studies have shown that Tai Chi Chuan (TCC) exercise can improve cognitive functions in healthy middle-aged and older adults, but not studies have investigated the neural mechanisms. Therefore, the purposes of this research project are: (1) to investigate the effects of TCC exercise intervention on improving cognitive functions and motor functions in healthy middle-aged and older adults; (2) to investigate the effects of TCC intervention on improving the integrity of frontostriatal fiber tracts, and areas and intensity of brain activation while performing a switching task in healthy middle-aged and older adults.
Methods: This project used the assessor-blind and randomized control clinical trial design. A total of 60 healthy middle-aged and older adults will be recruited, randomly allocated to two groups: experimental and control groups. Experimental group will receive a 60-minute exercise program, three times per week for 12 weeks. Control group will receive a telephone consultation once every two weeks for 12 weeks. All participants will receive clinical neuropsychological tests, Cambridge Neuropsychological Test Automated Battery tests, motor function tests, diffusion spectrum MR imaging, and functional MRI experiments before intervention, and at the end of intervention to realize the changes of cognitive function, motor function, integrity of neural tracts, and intensity and regions of functional activation while doing switching task of executive function in order to understand the cognitive effects and the neural mechanisms of TCC.
详细描述
Background: Promotion of cognitive functions of middle aged and older adults and prevention of dementia are important issues in the aging society. In recent years, studies have shown that Tai Chi Chuan (TCC) exercise can improve cognitive functions in healthy middle-aged and older adults, but not studies have investigated the neural mechanisms. Therefore, the purposes of this research project are: (1) to investigate the effects of TCC exercise intervention on improving cognitive functions and motor functions in healthy middle-aged and older adults; (2) to investigate the effects of TCC intervention on improving the integrity of frontostriatal fiber tracts, and areas and intensity of brain activation while performing a switching task in healthy middle-aged and older adults.
Methods: This project used the assessor-blind and randomized control clinical trial design. A total of 60 healthy middle-aged and older adults will be recruited, randomly allocated to two groups: experimental and control groups. Experimental group will receive a 60-minute exercise program, three times per week for 12 weeks. Control group will receive a telephone consultation once every two weeks for 12 weeks. All participants will receive clinical neuropsychological tests, Cambridge Neuropsychological Test Automated Battery tests, motor function tests, diffusion spectrum MR imaging, and functional MRI experiments before intervention, and at the end of intervention to realize the changes of cognitive function, motor function, integrity of neural tracts, and intensity and regions of functional activation while doing switching task of executive function in order to understand the cognitive effects and the neural mechanisms of TCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age range between 50 - 85 years old.
- •education level > 6 years or can read and speak Chinese
- •Montreal Cognitive Assessment Taiwan version (MoCA) score >= 26
- •Clinical Dementia Rating (CDR) score = 0
- •right dominant hand
排除标准
- •any neurological diseases, ex stroke, Parkinson's disease, trauma, epilepsy
- •cardiac disease, cardiac infarction, angina, uncontrolled hypertension
- •spiritual disease, anxiety or depression (Geriatric Depression Scale 15-item short-form score >= 8)
- •Daily ability need helps (instrumental activities of daily living, IADL has one item score= 0 or 1)
结局指标
主要结局
General cognitive function
时间窗: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Cognitive score on Montreal Cognitive Assessment Taiwan version (MoCA) and Clinical Dementia Rating (CDR).
Flexibility
时间窗: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Flexibility score (cm) on scratch test, chair sit and reach test.
Coordination
时间窗: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Coordination time (seconds) on four square step test and "Timed Up and Go" test
Physical activity level
时间窗: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Physical activity score on "Physical Activity Scale for the Elderly" questionnaire.
Executive function
时间窗: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Completed time (seconds) on Color Trail Test- Part 1\& 2, and number of errors from executive function task on Cambridge Neuropsychological Test Automated Battery (CANTAB).
Balance
时间窗: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Balance time (seconds) on eyes opened one-leg stance test.
Endurance
时间窗: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Walking distance (meters) on six-minute walking test.
Motor strength
时间窗: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Upper and lower limbs' muscle strength (kg) on handheld dynamometer, grip test, and to test lower limb strength by measuring the completed times in 30 seconds, chair rise test.
Memory function
时间窗: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Memory score on Cambridge Neuropsychological Test Automated Battery (CANTAB).
次要结局
- Brain functional activation(This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.)
- Brain structural integrity(This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.)
研究者
National Taiwan University Hospital
School and Graduate Institute of Physical Therapy College of Medicine
National Taiwan University Hospital