Clinical trial NCT02270320: Cognitive Effects of Tai Chi Chuan in Healthy Older Adults and Older Adults
Official title: Study of School and Graduate Institute of Physical Therapy College of Medicine in Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alteration of Cognitive Function
Keywords: Tai Chi Chuan
cognitive function
motor function
MRI
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 65
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: General cognitive function
timeFrame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
measure: Executive function
timeFrame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
measure: Motor strength
timeFrame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
measure: Flexibility
timeFrame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
measure: Balance
timeFrame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
measure: Coordination
timeFrame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
measure: Endurance
timeFrame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
measure: Physical activity level
timeFrame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
measure: Memory function
timeFrame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Secondary outcomes:
measure: Brain functional activation
timeFrame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
measure: Brain structural integrity
timeFrame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Other outcomes:
measure: Handness
timeFrame: This outcome will be assessed at baseline.
measure: Footness
timeFrame: This outcome will be assessed at baseline.
measure: Emotion
timeFrame: This outcome will be assessed at baseline.
measure: Basic physical function
timeFrame: This outcome will be assessed at baseline.
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng Dist
Study officials:
affiliation: School and Graduate Institute of Physical Therapy College of Medicine
name: Pei-Fang Tang, PhD
role: STUDY_CHAIR
References: