- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05629650
Feasibility Study of Tai Chi for Cognitively Impaired Older Adults (TCM)
Effects of 12-week Tai Chi Program on Physical Function, Depression, and Quality of Life Among Cognitively Impaired Older Adults: A Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the study are to determine the acceptability of a 12-week program of Tai Chi for memory (TCM) among older adults with mild cognitive impairment (MCI) or dementia; and to determine the effects of TCM on physical functioning, depression, and health-related QoL.
A quasi-experimental design was used with two groups classified according to the level of their cognitive impairment (MCI vs. Dementia).
Depression, health-related QoL, and physical functioning including grip strength, balance, flexibility, and mobility were measured before and after the 12-week TCM program.
Depression was measured using the Korean version of the Geriatric Depression Scale.
Health-related QoL was measured using the 12-item Short Form survey (SF-12). Grip strength was assessed using a digital hand dynamometer. Flexibility was assessed using the standard sit-and-reach test. Balance was measured using the one-leg-standing balance test. Mobility was assessed using the timed up and go test. Paired and independent t-tests will be used to compare the effects of TCM within and between groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Daejeon, Korea, Republic of, 35010
- Tai Chi for health institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- community-residing older adults aged 75 years or older,
- registered at the public dementia prevention centers for dementia screening by health professionals with the diagnosis of either MCI or dementia,
- Korean version of the Montreal Cognitive Assessment (MoCA-K) score of 22 or lower,
- agreed to participate in the Tai Chi program twice a week for 12 weeks.
Exclusion Criteria:
- participated in any formal regular exercise program during the previous 6 months, and
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Tai Chi for memory
TCM is a standardized type of Tai Chi for health developed by Dr. Lam specifically for those who experience or want to prevent cognitive problems.
TCM, consisting of 12 Sun-style and Yang-style Tai Chi movements, can be provided while sitting and while standing with five blocked movement sets so that cognitively impaired individuals (MCI vs. dementia) are able to follow them.
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The adapted form of TCM will be provided at 60 minutes per session, twice a week for 12 weeks by a certified Tai Chi instructor who had experience in teaching older adults with cognitive impairments.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
physical function-grip strength
Time Frame: changes from pretest to 12 week posttest scores
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grip strength by assessed in both hands using a digital hand dynamometer (0-90 kg; Labisen KS-301)
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changes from pretest to 12 week posttest scores
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physical function - flexibility
Time Frame: changes from pretest to 12 week posttest scores
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by the standard sit-and-reach test (SSRT)
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changes from pretest to 12 week posttest scores
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physical function - balance
Time Frame: changes from pretest to 12 week posttest scores
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assessed using a one-leg-standing balance test (OLST)
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changes from pretest to 12 week posttest scores
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physical function - mobility
Time Frame: changes from pretest to 12 week posttest scores
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assessed by the Timed Up and Go test (TUG)
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changes from pretest to 12 week posttest scores
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
emotional functioning - depression
Time Frame: changes from pretest to 12 week posttest scores
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assessed by the short form of the Korean version of the Geriatric Depression Scale (SGDS-K) with 16 items (yes/no).
higher scores indicate more depressive symptoms
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changes from pretest to 12 week posttest scores
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Short Form Health Survey 12 (SF12)
Time Frame: changes from pretest to 12 week posttest scores
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Short Form Health Survey 12, which consists of eight dimensions: general health, physical functioning, role physical, body pain, vitality, social functioning, role emotional, and mental health.
two summary scores for the physical and mental components of health-related QoL are calculated by using the weighted means for the eight domains.
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changes from pretest to 12 week posttest scores
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rhayun Song, PhD, Chungnam National University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChungnamNU3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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