- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02552329
Effects of Tai Chi Exercise on Cognition and Serum Biomarkers of Individuals With MCI (MCI-TaiChi)
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)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Chiang Mai
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Maung, Chiang Mai, Thailand, 50200
- Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control group
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.
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Experimental: Tai Chi exercise group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in cognitive functions at 6 months
Time Frame: 6 months
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memory, attention, executive function will be evaluated
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in serum biomarkers at 6 months
Time Frame: 6 month
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inflammatory markers will be evaluated.
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6 month
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Change from baseline in fall risk at 6 months
Time Frame: 6 months
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Fall risk index will be evaluated using physiological profile approach (PPA)
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6 months
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Change from baseline in quality of life at 6 months
Time Frame: 6 months
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Health related quality of life will be evaluated using the Short Form 36 (SF-36) questionnaire.
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6 months
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Change from baseline in cognitive functions at 3 months
Time Frame: 3 months
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memory, attention, executive function will be evaluated
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3 months
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Change from baseline in fall risk at 3 months
Time Frame: 3 months
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Fall risk index will be evaluated using physiological profile approach (PPA)
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Somporn Sungkarat, PhD, Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai, Thailand
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chiang Mai University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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