Skip to main content
Clinical Trials/NCT02270320
NCT02270320CompletedNot Applicable

Study of School and Graduate Institute of Physical Therapy College of Medicine in Taiwan

National Taiwan University Hospital1 site in 1 country65 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
65
Locations
1
Primary Endpoint
General cognitive function

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

Control

No Intervention

Control group will receive a telephone consultation once every two weeks for 12 weeks.

Physical activity

Active Comparator

Experimental group will receive a 60-minute 24 forms Yang-style Tai Chi Chuan exercise program, three times per week for 12 weeks.

Intervention: Physical activity (Behavioral)

Outcomes

Primary Outcomes

General cognitive function

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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).

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

National Taiwan University Hospital

School and Graduate Institute of Physical Therapy College of Medicine

National Taiwan University Hospital

Study Sites (1)

Loading locations...

Similar Trials