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

Alteration of Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270320
• Other study ID #: 201212161RIND
• Secondary ID: NSC 102-2410-H-0
• Status: Completed
• Phase: N/A
• First received: September 9, 2014
• Last updated: November 9, 2015
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alteration of Cognitive Function

Intervention

Behavioral:
• Physical activity
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Zhongzheng Dist

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Handness	Handness score on "Edinburgh Handedness Inventory" questionnaire.	This outcome will be assessed at baseline.	Yes
Other	Footness	Footless score on "Waterloo Footedness Questionnaire".	This outcome will be assessed at baseline.	Yes
Other	Emotion	Depression score on "Geriatric Depression Scale 15-item short-form".	This outcome will be assessed at baseline.	Yes
Other	Basic physical function	Basic physical score on " instrumental activities of daily living" questionnaire.	This outcome will be assessed at baseline.	Yes
Primary	General cognitive function	Cognitive score on Montreal Cognitive Assessment Taiwan version (MoCA) and Clinical Dementia Rating (CDR).	This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.	Yes
Primary	Executive function	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).	This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.	Yes
Primary	Motor strength	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.	This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.	Yes
Primary	Flexibility	Flexibility score (cm) on scratch test, chair sit and reach test.	This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.	Yes
Primary	Balance	Balance time (seconds) on eyes opened one-leg stance test.	This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.	Yes
Primary	Coordination	Coordination time (seconds) on four square step test and "Timed Up and Go" test	This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.	Yes
Primary	Endurance	Walking distance (meters) on six-minute walking test.	This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.	Yes
Primary	Physical activity level	Physical activity score on "Physical Activity Scale for the Elderly" questionnaire.	This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.	Yes
Primary	Memory function	Memory score on Cambridge Neuropsychological Test Automated Battery (CANTAB).	This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.	Yes
Secondary	Brain functional activation	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.	This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.	Yes
Secondary	Brain structural integrity	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.	This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.	Yes