Cognitive ImpairmentTCMNCT05629650
Feasibility Study of Tai Chi for Cognitively Impaired Older Adults
A study testing Tai Chi for memory in people with Cognitive Impairment, run by Chungnam National University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 75 to 90 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Tai Chi for memory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2018to 10 Jan 2022
- 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 75 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- participated in any formal regular exercise program during the previous 6 months, and
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cognitive Impairment
- Being tested
- Tai Chi for memory
- Keywords
- Tai Chi, cognitive impairment, dementia
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi for memoryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi for memory | Experimental | 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. Receives: Behavioral: Tai Chi for memory |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical function-grip strength
grip strength by assessed in both hands using a digital hand dynamometer (0-90 kg; Labisen KS-301)
Measured: changes from pretest to 12 week posttest scores
physical function - flexibility
by the standard sit-and-reach test (SSRT)
Measured: changes from pretest to 12 week posttest scores
physical function - balance
assessed using a one-leg-standing balance test (OLST)
Measured: changes from pretest to 12 week posttest scores
physical function - mobility
assessed by the Timed Up and Go test (TUG)
Measured: changes from pretest to 12 week posttest scores
Secondary outcomes (2)
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
Measured: changes from pretest to 12 week posttest scores
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.
Measured: changes from pretest to 12 week posttest scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Jul 2018
- Primary completion28 Jan 2019
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- two intervention groups (1) those with MCI (2) those with dementia
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chungnam National University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation, Singapore
- Responsible party
- Principal investigator, Rhayun Song, Chungnam National University
- Investigators
- Rhayun Song, PhD, Principal investigator, Chungnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629650
- Sponsor's protocol ID
- ChungnamNU3
- Acronym
- TCM
- Status last verified
- Nov 2022
- First submitted
- 12 Nov 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon request, study protocol and the data without individual IDs can be shared with other researchers.
Publications
Oh H, Song R, Kim SJ. Effects of 12-week Tai Chi program on physical function, depression, and quality of life among cognitively impaired older adults: a feasibility study. BMC Geriatr. 2023 Mar 3;23(1):118. doi: 10.1186/s12877-023-03840-2.
PubMed 36869290
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05629650
- Acronym / sponsor ID
- TCM / ChungnamNU3
- Conditions
- Cognitive Impairment
- Keywords
- Tai Chi, cognitive impairment, dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chungnam National UniversityUniversity, hospital or other
- Collaborators
- National Research Foundation, Singapore
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 29 Nov 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- two intervention groups (1) those with MCI (2) those with dementia
| Arm | Type | Receives |
|---|---|---|
| Tai Chi for memory | Experimental | Behavioral: Tai Chi for memoryTCM 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. |
Who may qualify
- Ages
- 75 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- participated in any formal regular exercise program during the previous 6 months, and
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 for memoryThe 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. | Behavioural | Tai Chi for memory |
Primary outcome
physical function-grip strength
Time frame: changes from pretest to 12 week posttest scores
grip strength by assessed in both hands using a digital hand dynamometer (0-90 kg; Labisen KS-301)
physical function - flexibility
Time frame: changes from pretest to 12 week posttest scores
by the standard sit-and-reach test (SSRT)
physical function - balance
Time frame: changes from pretest to 12 week posttest scores
assessed using a one-leg-standing balance test (OLST)
physical function - mobility
Time frame: changes from pretest to 12 week posttest scores
assessed by the Timed Up and Go test (TUG)
2 secondary outcomes
emotional functioning - depression
Time frame: changes from pretest to 12 week posttest scores
Short Form Health Survey 12 (SF12)
Time frame: changes from pretest to 12 week posttest scores
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 1 Dec 2022.
- Derived from this study: PubMed 36869290Oh H, Song R, Kim SJ. Effects of 12-week Tai Chi program on physical function, depression, and quality of life among cognitively impaired older adults: a feasibility study. BMC Geriatr. 2023 Mar 3;23(1):118. doi: 10.1186/s12877-023-03840-2.
- Individual participant dataSharing planned: Yes. upon request, study protocol and the data without individual IDs can be shared with other researchers.
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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.
Rhayun Song, PhD principal investigator
Chungnam National University
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 for memory in people with Cognitive Impairment, run by Chungnam National University at 1 site in South Korea.
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 4 inclusion and 1 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 1 Dec 2022. 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 South Korea. 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?
physical function-grip strength (time frame: changes from pretest to 12 week posttest scores). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05629650, which also lists 1 linked publication.
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 1 Dec 2022.