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Feasibility Study of Tai Chi for Cognitively Impaired Older Adults (TCM)

Primary Purpose

Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tai Chi for memory
Sponsored by
Chungnam National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment focused on measuring Tai Chi, cognitive impairment, dementia

Eligibility Criteria

75 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tai Chi for health institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tai Chi for memory

Arm Description

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.

Outcomes

Primary Outcome Measures

physical function-grip strength
grip strength by assessed in both hands using a digital hand dynamometer (0-90 kg; Labisen KS-301)
physical function - flexibility
by the standard sit-and-reach test (SSRT)
physical function - balance
assessed using a one-leg-standing balance test (OLST)
physical function - mobility
assessed by the Timed Up and Go test (TUG)

Secondary Outcome Measures

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
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.

Full Information

First Posted
November 12, 2022
Last Updated
November 29, 2022
Sponsor
Chungnam National University
Collaborators
National Research Foundation, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05629650
Brief Title
Feasibility Study of Tai Chi for Cognitively Impaired Older Adults
Acronym
TCM
Official Title
Effects of 12-week Tai Chi Program on Physical Function, Depression, and Quality of Life Among Cognitively Impaired Older Adults: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
January 28, 2019 (Actual)
Study Completion Date
January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chungnam National University
Collaborators
National Research Foundation, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
Tai Chi, cognitive impairment, dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
two intervention groups (1) those with MCI (2) those with dementia
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi for memory
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi for memory
Intervention Description
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.
Primary Outcome Measure Information:
Title
physical function-grip strength
Description
grip strength by assessed in both hands using a digital hand dynamometer (0-90 kg; Labisen KS-301)
Time Frame
changes from pretest to 12 week posttest scores
Title
physical function - flexibility
Description
by the standard sit-and-reach test (SSRT)
Time Frame
changes from pretest to 12 week posttest scores
Title
physical function - balance
Description
assessed using a one-leg-standing balance test (OLST)
Time Frame
changes from pretest to 12 week posttest scores
Title
physical function - mobility
Description
assessed by the Timed Up and Go test (TUG)
Time Frame
changes from pretest to 12 week posttest scores
Secondary Outcome Measure Information:
Title
emotional functioning - depression
Description
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
Time Frame
changes from pretest to 12 week posttest scores
Title
Short Form Health Survey 12 (SF12)
Description
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.
Time Frame
changes from pretest to 12 week posttest scores

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhayun Song, PhD
Organizational Affiliation
Chungnam National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tai Chi for health institute
City
Daejeon
ZIP/Postal Code
35010
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
upon request, study protocol and the data without individual IDs can be shared with other researchers.
IPD Sharing Time Frame
January-December, 2024
IPD Sharing Access Criteria
researchers or reviewers who requested for clinical study or meta-analysis

Learn more about this trial

Feasibility Study of Tai Chi for Cognitively Impaired Older Adults

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