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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05629650
Other study ID # ChungnamNU3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date January 10, 2022

Study information

Verified date November 2022
Source Chungnam National University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to determine the feasibility 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. Two experimental groups will be recruited for inclusion criteria of community-residing older adults with a diagnosis of either MCI or Dementia.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date January 10, 2022
Est. primary completion date January 28, 2019
Accepts healthy volunteers No
Gender All
Age group 75 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Tai Chi for memory
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.

Locations

Country Name City State
Korea, Republic of Tai Chi for health institute Daejeon

Sponsors (2)

Lead Sponsor Collaborator
Chungnam National University National Research Foundation, Singapore

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary physical function-grip strength grip strength by assessed in both hands using a digital hand dynamometer (0-90 kg; Labisen KS-301) changes from pretest to 12 week posttest scores
Primary physical function - flexibility by the standard sit-and-reach test (SSRT) changes from pretest to 12 week posttest scores
Primary physical function - balance assessed using a one-leg-standing balance test (OLST) changes from pretest to 12 week posttest scores
Primary physical function - mobility assessed by the Timed Up and Go test (TUG) changes from pretest to 12 week posttest scores
Secondary emotional functioning - depression 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 changes from pretest to 12 week posttest scores
Secondary Short Form Health Survey 12 (SF12) 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. changes from pretest to 12 week posttest scores
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