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Completed

NCT Number: NCT02270320

Cognitive Effects of Tai Chi Chuan in Healthy Older Adults and Older Adults

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Zhongzheng Dist, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physical activity

Behavioral

The training is 24 forms Yang-style Tai Chi Chuan exercise, which will perform a 60-minute exercise program, three times per week for 12 weeks.

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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

  1. Brain functional activation

    Time frame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

    Brain MR images were obtained with a 3T Siemens (Erlangen, Germany) whole-body MRI scanner. A Siemens 32-channel head array coil was used as a receiver. Functional MRI (fMRI) was acquired using a BOLD-weighted gradient-echo echoplanar image sequence (EPI) ( TR/TE=2000/24 ms, field of view= 192 mm, voxel dimensions 3 x 3 x 4 mm, matrix= 64 x 64, slice thickness= 4 mm, flip angle 90°), and 34 slices will be obtained with anterior-posterior phase encoding direction and covering the whole brain. The fMRI paradigm was the event-related designed switching task by E-prime 2.0. The fMRI imaging data processing and analysis were accomplished using SPM8 (Wellcome Department of Imaging Neuroscience). Statistical parametric maps of the t statistic, SPM{t}, were obtained with the threshold of p< 0.001 uncorrected. The brain functional activation results will be presented by the p value and the magnitude of Blood-oxygen-level dependent (BOLD) intensity.

  2. Brain structural integrity

    Time frame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.

    Structural MRI was measured by T1, T2, and diffusion spectrum imaging (DSI). DSI will be performed to reconstruct tractography of the neural tracts. The DSI data was acquired by using a pulsed-gradient spin-echo diffusion EPI. The maximum diffusion sensitivity b value=4000 s/mm2, TR/TE=9600/130 ms, FOV=200 mm, and thickness=2.5 mm. Approximately 56 transaxial slices will be acquired encompassing the whole brain. The general fractional anisotropy (GFA) values, a quantitative index derived from the orientation distribution function to indicate diffusion anisotropy, were calculated at each voxel, The reconstruction of the tracts tractography was performed by using DSI Studio software. The integrity of these neural tracts will be presented by GFA value.

Other outcomes

  1. Handness

    Time frame: This outcome will be assessed at baseline.

    Handness score on "Edinburgh Handedness Inventory" questionnaire.

  2. Footness

    Time frame: This outcome will be assessed at baseline.

    Footless score on "Waterloo Footedness Questionnaire".

  3. Emotion

    Time frame: This outcome will be assessed at baseline.

    Depression score on "Geriatric Depression Scale 15-item short-form".

  4. Basic physical function

    Time frame: This outcome will be assessed at baseline.

    Basic physical score on " instrumental activities of daily living" questionnaire.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2014
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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