Mild Cognitive ImpairmentMCI-TaiChiNCT02552329
Effects of Tai Chi Exercise on Cognition and Serum Biomarkers of Individuals With MCI
A study testing Tai Chi exercise in people with Mild Cognitive Impairment, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Most research on Tai Chi has been done in the area of balance and falls. Studies examining the effects of Tai Chi exercise on cognitive function are sparse especially in the population of MCI. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Tai Chi exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2013to Jul 2016
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis for MCI based on Petersen's criteria as follows:
- A self-reported memory complaint, corroborated by an informant interview
- A score on a standardized memory test rated as 0.5 on Clinical Dementia Rating (CDR)
- Normal general cognitive function, as determined by a clinician's judgment based on a structured interview with the patient and an informant report and adjusted Thai Mini-Mental State Examination (TMSE) 35
- No or minimal impairment in activities of daily living (ADLs) or instrumental Activity of Daily Living (IADL), as determined by clinical review with the patients and informant interview
- Not sufficiently impaired, cognitively and functionally, to meet National Institute of Neurological and Communicative Disorders and Stroke/ Alzheimer's disease and Related Association (NINCDS-ADRDA) criteria for AD, as judged by an experienced AD clinician
- Presence of cognitive impairment determined by the score on the Montreal Cognitive Assessment (MoCA) lesser than 26
- Comprehend instructions and willing to participate
Who cannot join
- Presence of medical conditions that would be unsafe to exercise
- Presence of neurological conditions (e.g. Parkinson's disease, Stroke, Multiple Sclerosis)
- Presence of depressive symptoms, defined by the Geriatric Depression Scale (GDS)-Thai version 36
- Presence of acute or/and chronic disease that could not be controlled (e.g. Arthritis, Asthma, Hypertension, Diabetes mellitus, Coronary artery disease)
- Taking alcohol 6 hr before testing or using drug regimens that affect performance such as sedative and antidepressant.
- Exercise regularly (40-50 min/day at least 3 days/week)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University
Maung, Chiang Mai, 50200
About this study
Official title: A Randomized Controlled Trial of Mind-body Exercise: Effects of a 6-month Tai Chi Exercise on Cognition and Serum Biomarkers of Individuals With Mild Cognitive Impairment (MCI)
Most research on Tai Chi has been done in the area of balance and falls. Studies examining the effects of Tai Chi exercise on cognitive function are sparse especially in the population of MCI. Therefore, the aims of the present study are: 1) to examine the effects of Tai Chi exercise on cognitive function of elderly with MCI, and 2) to investigate the effects of 6-month Tai Chi exercise on serum biomarkers in individuals with MCI.
Read the detailed description
Mild Cognitive Impairment (MCI) is a transitional stage before converting from normal aging to dementia. Older adults with MCI are 10 times more likely to develop dementia than cognitively intact older adults. Thus, strategies that could deter the conversion from MCI to dementia will have significant impact on public health.
There is growing interest in non-pharmacological approaches that could potentially slow down cognitive decline in late life. One such approach is the use of exercise to improve cognitive function. There is substantial evidence that exercise has benefits for cognitive function in elderly persons. Evidence on the benefits of exercise for cognition (either cognitive improvement or reduced cognitive decline) has been demonstrated through epidemiological studies, meta-analytical studies, and randomized controlled trials.
Although exercise training holds promise for delaying the onset and slowing down the progression of cognitive impairment among elderly persons, most studies utilized aerobic-base exercise with relatively high intensity. High intensity aerobic exercise may not be practical for older people because they are likely to have physical limitations and/or co-morbid diseases.Thus, the effects of other forms of exercise particularly those that are less intense and well suited to elderly conditions should be examined. The moderating factors linking exercise training and cognitive improvement is yet to be further investigated.
Tai Chi, a form of mind-body exercise, is a popular exercise among elderly. Although Tai Chi is considered as an aerobic exercise, the focus of this exercise in elders is not on cardiovascular fitness. It is characterized by slow, gentle motion and emphasized the conscious control of body movements. Several cognitive components including attention and mindfulness engage with physical movements during Tai Chi exercise. Thus, it is expected that Tai Chi exercise would have great benefit on cognition. Most research on Tai Chi has been done in the area of balance and falls. Studies examining the effects of Tai Chi exercise on cognitive function are sparse especially in the population of mild cognitive impairment.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Tai Chi exercise
- Keywords
- mild cognitive impairment, Tai Chi, cognitive functions
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi exerciseOther
The Tai Chi exercise group will exercise for 50 minutes/session, 3 times /week for 24 consecutive weeks (6 months). Each 50-minute session will include a 10-minute warm up, 30-min exercise, and 10-min cool down, The 10 forms Tai Chi will be used.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Since no medication or other treatments are currently approved by Food and Drug Administration (FDA) for treatment of MCI, participants in the usual care group will not receive any form of treatment. They will receive an educational material about cognitive impairment. They will also be asked to maintain their daily routine. |
| Tai Chi exercise group | Experimental | The Tai Chi exercise group will exercise for 50 minutes/session, 3 times /week for 24 consecutive weeks (6 months). Each 50-minute session will include a 10-minute warm up, 30-min exercise, and 10-min cool down. Receives: Other: Tai Chi exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cognitive functions at 6 months
memory, attention, executive function will be evaluated
Measured: 6 months
Secondary outcomes (5)
Change from baseline in serum biomarkers at 6 months
inflammatory markers will be evaluated.
Measured: 6 month
Change from baseline in fall risk at 6 months
Fall risk index will be evaluated using physiological profile approach (PPA)
Measured: 6 months
Change from baseline in quality of life at 6 months
Health related quality of life will be evaluated using the Short Form 36 (SF-36) questionnaire.
Measured: 6 months
Change from baseline in cognitive functions at 3 months
memory, attention, executive function will be evaluated
Measured: 3 months
Change from baseline in fall risk at 3 months
Fall risk index will be evaluated using physiological profile approach (PPA)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startDec 2013
- Primary completionMar 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somporn Sungkarat, Chiang Mai University
- Investigators
- Somporn Sungkarat, PhD, Principal investigator, Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552329
- Sponsor's protocol ID
- Chiang Mai University
- Acronym
- MCI-TaiChi
- Status last verified
- Jul 2016
- First submitted
- 16 Jan 2014
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Mind-body Exercise: Effects of a 6-month Tai Chi Exercise on Cognition and Serum Biomarkers of Individuals With Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT02552329
- Acronym / sponsor ID
- MCI-TaiChi / Chiang Mai University
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, Tai Chi, cognitive functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Sep 2015 (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.
Most research on Tai Chi has been done in the area of balance and falls. Studies examining the effects of Tai Chi exercise on cognitive function are sparse especially in the population of MCI. Therefore, the aims of the present study are: 1) to examine the effects of Tai Chi exercise on cognitive function of elderly with MCI, and 2) to investigate the effects of 6-month Tai Chi exercise on serum biomarkers in individuals with MCI.
Detailed description
Mild Cognitive Impairment (MCI) is a transitional stage before converting from normal aging to dementia. Older adults with MCI are 10 times more likely to develop dementia than cognitively intact older adults. Thus, strategies that could deter the conversion from MCI to dementia will have significant impact on public health.
There is growing interest in non-pharmacological approaches that could potentially slow down cognitive decline in late life. One such approach is the use of exercise to improve cognitive function. There is substantial evidence that exercise has benefits for cognitive function in elderly persons. Evidence on the benefits of exercise for cognition (either cognitive improvement or reduced cognitive decline) has been demonstrated through epidemiological studies, meta-analytical studies, and randomized controlled trials.
Although exercise training holds promise for delaying the onset and slowing down the progression of cognitive impairment among elderly persons, most studies utilized aerobic-base exercise with relatively high intensity. High intensity aerobic exercise may not be practical for older people because they are likely to have physical limitations and/or co-morbid diseases.Thus, the effects of other forms of exercise particularly those that are less intense and well suited to elderly conditions should be examined. The moderating factors linking exercise training and cognitive improvement is yet to be further investigated.
Tai Chi, a form of mind-body exercise, is a popular exercise among elderly. Although Tai Chi is considered as an aerobic exercise, the focus of this exercise in elders is not on cardiovascular fitness. It is characterized by slow, gentle motion and emphasized the conscious control of body movements. Several cognitive components including attention and mindfulness engage with physical movements during Tai Chi exercise. Thus, it is expected that Tai Chi exercise would have great benefit on cognition. Most research on Tai Chi has been done in the area of balance and falls. Studies examining the effects of Tai Chi exercise on cognitive function are sparse especially in the population of mild cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Since no medication or other treatments are currently approved by Food and Drug Administration (FDA) for treatment of MCI, participants in the usual care group will not receive any form of treatment. They will receive an educational material about cognitive impairment. They will also be asked to maintain their daily routine. |
| Tai Chi exercise group | Experimental | Other: Tai Chi exerciseThe Tai Chi exercise group will exercise for 50 minutes/session, 3 times /week for 24 consecutive weeks (6 months). Each 50-minute session will include a 10-minute warm up, 30-min exercise, and 10-min cool down. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis for MCI based on Petersen's criteria as follows:
- Presence of cognitive impairment determined by the score on the Montreal Cognitive Assessment (MoCA) lesser than 26
- Comprehend instructions and willing to participate
Key exclusion criteria (6 listed)
- Presence of medical conditions that would be unsafe to exercise
- Presence of neurological conditions (e.g. Parkinson's disease, Stroke, Multiple Sclerosis)
- Presence of depressive symptoms, defined by the Geriatric Depression Scale (GDS)-Thai version 36
- Presence of acute or/and chronic disease that could not be controlled (e.g. Arthritis, Asthma, Hypertension, Diabetes mellitus, Coronary artery disease)
- Taking alcohol 6 hr before testing or using drug regimens that affect performance such as sedative and antidepressant.
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 |
|---|---|---|
| Tai Chi exerciseThe Tai Chi exercise group will exercise for 50 minutes/session, 3 times /week for 24 consecutive weeks (6 months). Each 50-minute session will include a 10-minute warm up, 30-min exercise, and 10-min cool down, The 10 forms Tai Chi will be used. | Other | Tai Chi exercise group |
Primary outcome
Change from baseline in cognitive functions at 6 months
Time frame: 6 months
memory, attention, executive function will be evaluated
5 secondary outcomes
Change from baseline in serum biomarkers at 6 months
Time frame: 6 month
Change from baseline in fall risk at 6 months
Time frame: 6 months
Change from baseline in quality of life at 6 months
Time frame: 6 months
Change from baseline in cognitive functions at 3 months
Time frame: 3 months
Change from baseline in fall risk at 3 months
Time frame: 3 months
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 28 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Somporn Sungkarat, PhD principal investigator
Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi exercise in people with Mild Cognitive Impairment, run by Chiang Mai University at 1 site in Thailand.
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 8 inclusion and 6 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 28 Jul 2016. 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 Thailand. 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?
Change from baseline in cognitive functions at 6 months (time frame: 6 months). 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 28 Jul 2016.