Alteration of Cognitive FunctionNCT02270320
Cognitive Effects of Tai Chi Chuan in Healthy Older Adults and Older Adults
A study testing Physical activity in people with Alteration of Cognitive Function, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alteration of Cognitive Function
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of School and Graduate Institute of Physical Therapy College of Medicine in 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.
Read the 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.
- Conditions
- Alteration of Cognitive Function
- Being tested
- Physical activity
- Keywords
- Tai Chi Chuan, cognitive function, motor function, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
General cognitive function
Cognitive score on Montreal Cognitive Assessment Taiwan version (MoCA) and Clinical Dementia Rating (CDR).
Measured: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
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).
Measured: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
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.
Measured: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Flexibility
Flexibility score (cm) on scratch test, chair sit and reach test.
Measured: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Balance
Balance time (seconds) on eyes opened one-leg stance test.
Measured: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Coordination
Coordination time (seconds) on four square step test and "Timed Up and Go" test
Measured: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Endurance
Walking distance (meters) on six-minute walking test.
Measured: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Physical activity level
Physical activity score on "Physical Activity Scale for the Elderly" questionnaire.
Measured: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Memory function
Memory score on Cambridge Neuropsychological Test Automated Battery (CANTAB).
Measured: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Secondary outcomes (2)
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.
Measured: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
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.
Measured: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alteration of Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Pei-Fang Tang, PhD, Study chair, School and Graduate Institute of Physical Therapy College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270320
- Sponsor's protocol ID
- 201212161RIND
- Other IDs
- NSC 102-2410-H-002 -213 -MY2
- Status last verified
- Nov 2015
- First submitted
- 9 Sep 2014
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of School and Graduate Institute of Physical Therapy College of Medicine in Taiwan
- ClinicalTrials.gov ID
- NCT02270320
- Acronym / sponsor ID
- 201212161RIND
- Conditions
- Alteration of Cognitive Function
- Keywords
- Tai Chi Chuan, cognitive function, motor function, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group will receive a telephone consultation once every two weeks for 12 weeks. |
| Physical activity | Active comparator | Behavioral: Physical activityExperimental group will receive a 60-minute 24 forms Yang-style Tai Chi Chuan exercise program, three times per week for 12 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityThe 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. | Behavioural | Physical activity |
Primary outcome
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).
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).
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.
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.
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.
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
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.
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.
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).
2 secondary outcomes
Brain functional activation
Time frame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Brain structural integrity
Time frame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
Related trials for Alteration of Cognitive Function
Not yet recruitingPhase 1
Minocycline In Neurocognitive Outcomes - Sickle Cell Disease
Sickle Cell Disease, Cognitive Impairment
Not yet recruitingObservational study
A Prospective Study of Cognitive Changes in Retired and Late-Career Professional Soccer Players
Cognitive Impairment, Chronic Traumatic Encephalopathy (CTE)
Recruiting
Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging
Aging, Cognitive Change
Enrolling by invitationObservational study
Digitally-enhanced, Decentralized, Multi-omics Observational Cohort
Presymptomatic Disease, Mild Cognitive Impairment
Active, not recruiting
Rehabilitation of Cognitive Changes in Breast Cancer Survivors
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Fang Tang, PhD study chair
School and Graduate Institute of Physical Therapy College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Alteration of Cognitive Function, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General cognitive function (time frame: This outcome will be assessed at baseline and up to 12 weeks exercise or control intervention.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.