National Taiwan University Hospital
Taipei, Zhongzheng Dist, 100, Taiwan
NCT Number: NCT02270320
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.
Looking for future studies?
Notify Me50 year–85 year
All sexes
Interventional
Not applicable
Taipei, Zhongzheng Dist, 100, Taiwan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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).
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.
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.
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.
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
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.
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.
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).
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.
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.
Time frame: This outcome will be assessed at baseline.
Handness score on "Edinburgh Handedness Inventory" questionnaire.
Time frame: This outcome will be assessed at baseline.
Footless score on "Waterloo Footedness Questionnaire".
Time frame: This outcome will be assessed at baseline.
Depression score on "Geriatric Depression Scale 15-item short-form".
Time frame: This outcome will be assessed at baseline.
Basic physical score on " instrumental activities of daily living" questionnaire.
National Taiwan University Hospital
Other
Study of School and Graduate Institute of Physical Therapy College of Medicine in Taiwan
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.
Published trials that share one or more normalized conditions with this study.
NCT02486328
Alteration of Cognitive Function, Cognition Disorders
View Trial DetailsNCT02300272
Ageing, Alteration of Cognitive Function
Gainesville, Florida, United States
View Trial DetailsNCT02847793
Alteration of Cognitive Function, Behavior
Madrid, Spain
View Trial DetailsNCT02958735
Alteration of Cognitive Function, Behavior
Baltimore, Maryland, United States
View Trial Details