Mild Cognitive ImpairmentNCT06375720
Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons With Mild Cognitive Impairment
A study testing Lower frequency, shorter period of Tai Chi Chuan, Higher frequency, shorter period of Tai Chi Chuan and Lower frequency, longer period of Tai Chi Chuan in people with Mild Cognitive Impairment, run by Lidian Chen.
Trial summary
To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Lower frequency, shorter period of Tai Chi Chuan, Higher frequency, shorter period of Tai Chi Chuan and Lower frequency, longer period of Tai Chi Chuan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2024to 15 Dec 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of mild cognitive impairment, not demented;
- Age ≥ 60 years old;
- Informed consent and voluntary participation.
Who cannot join
- Geriatric Depression Scale score ≥ 9 points;
- Cognitive impairment caused by other reasons, taking drugs, poisoning, etc;
- Suffer from severe musculoskeletal system diseases and other contraindications to exercise and are not suitable for Tai Chi Chuan training, such as those who suffer from stroke, Parkinson's disease, and have a history of lower limb arthritis, hip and knee joint replacement, etc;
- Patients with severe heart, liver, kidney failure, malignant tumors, and other major diseases;
- Individuals with visual/auditory impairments, writing/reading impairments, illiteracy, etc. that affect training and evaluation;
- Individuals with uncontrolled hypertension (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg after medication);
- Participating in other experiments that influence this study;
- Engaged in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time).
About this study
Official title: Dose-effect of Different Frequencies and Duration of Tai Chi Chuan to Improve Cognitive Function in Persons With Mild Cognitive Impairment
To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment.
Read the detailed description
Mild cognitive impairment (MCI) is regarded as a prodrome to dementia and affects 16% to 20% of people aged older than 65 years. Tai Chi Chuan is an increasingly popular multi-modal physical and mental exercise. Studies have shown that Tai Chi Chuan can effectively improve the cognitive function of elderly persons with MCI. However, the relationship between the effects of different frequencies and duration of Tai Chi Chuan to improve the cognitive function of elderly persons with MCI is not yet clear. The purpose of this study is to determine the optimal frequency and duration of Tai Chi Chuan. The investigators will conduct a single-blind, randomized controlled trial in 350 persons who meet the presence of MCI without dementia. Persons will be randomly assigned to either the Tai Chi Chuan intervention group once or twice a week for 12 or 24 weeks, or the health education control group once every four weeks for 24 weeks. All groups will be followed for 52 weeks.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Lower frequency, shorter period of Tai Chi Chuan, Higher frequency, shorter period of Tai Chi Chuan, Lower frequency, longer period of Tai Chi Chuan, Higher frequency, longer period of Tai Chi Chuan, Standard Health Education
- Keywords
- Tai Chi Chuan, Cognitive Function
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower frequency, shorter period of Tai Chi ChuanBehavioural
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3 sessions/week for 12 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.
Higher frequency, shorter period of Tai Chi ChuanBehavioural
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 12 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.
Lower frequency, longer period of Tai Chi ChuanBehavioural
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3 sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.
Higher frequency, longer period of Tai Chi ChuanBehavioural
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.
Standard Health EducationBehavioural
Participants would take standard health education 0.5 hour/ session, 2 sessions/month for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Chuan Group1 | Experimental | 12 weeks of Tai Chi Chuan, 3x/week Receives: Behavioral: Lower frequency, shorter period of Tai Chi Chuan |
| Tai Chi Chuan Group2 | Experimental | 12 weeks of Tai Chi Chuan, 5x/week Receives: Behavioral: Higher frequency, shorter period of Tai Chi Chuan |
| Tai Chi Chuan Group3 | Experimental | 24 weeks of Tai Chi Chuan, 3x/week Receives: Behavioral: Lower frequency, longer period of Tai Chi Chuan |
| Tai Chi Chuan Group4 | Experimental | 24 weeks of Tai Chi Chuan, 5x/week Receives: Behavioral: Higher frequency, longer period of Tai Chi Chuan |
| Control | Sham comparator | Participants would take standard health education 0.5hour/ session, 2 sessions/month for 6 months. Receives: Behavioral: Standard Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment
Global cognition
Measured: 12 weeks, 24 weeks
Secondary outcomes (8)
Montreal Cognitive Assessment
Global cognition
Measured: 52 weeks
Wechsler Memory Scale
Memory function
Measured: 12 weeks, 24 weeks and 52 weeks
Digit Symbol Substitution Test
Attention
Measured: 12 weeks, 24 weeks and 52 weeks
Trial Making Test part B
Executive Function
Measured: 12 weeks, 24 weeks and 52 weeks
Stroop Color Word Test
Processing Speed
Measured: 12 weeks, 24 weeks and 52 weeks
Boston Naming Test
Verbal fluency
Measured: 12 weeks, 24 weeks and 52 weeks
Rey-Osterrieth Complex Graphics Test
Visuo-spatial ability
Measured: 12 weeks, 24 weeks and 52 weeks
Rey Auditory Verbal Learning Test
Episodic memory
Measured: 12 weeks, 24 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start5 May 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lidian Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital
- Responsible party
- Sponsor-investigator, Lidian Chen, Fujian University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375720
- Sponsor's protocol ID
- FujianUTCM-2
- Status last verified
- Apr 2024
- First submitted
- 21 Mar 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-effect of Different Frequencies and Duration of Tai Chi Chuan to Improve Cognitive Function in Persons With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06375720
- Acronym / sponsor ID
- FujianUTCM-2
- Conditions
- Mild Cognitive Impairment
- Keywords
- Tai Chi Chuan, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Lidian ChenUniversity, hospital or other
- Collaborators
- Peking University Third Hospital
- Study start
- 5 May 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 19 Apr 2024 (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.
To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment.
Detailed description
Mild cognitive impairment (MCI) is regarded as a prodrome to dementia and affects 16% to 20% of people aged older than 65 years. Tai Chi Chuan is an increasingly popular multi-modal physical and mental exercise. Studies have shown that Tai Chi Chuan can effectively improve the cognitive function of elderly persons with MCI. However, the relationship between the effects of different frequencies and duration of Tai Chi Chuan to improve the cognitive function of elderly persons with MCI is not yet clear. The purpose of this study is to determine the optimal frequency and duration of Tai Chi Chuan. The investigators will conduct a single-blind, randomized controlled trial in 350 persons who meet the presence of MCI without dementia. Persons will be randomly assigned to either the Tai Chi Chuan intervention group once or twice a week for 12 or 24 weeks, or the health education control group once every four weeks for 24 weeks. All groups will be followed for 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Chuan Group1 | Experimental | Behavioral: Lower frequency, shorter period of Tai Chi Chuan12 weeks of Tai Chi Chuan, 3x/week |
| Tai Chi Chuan Group2 | Experimental | Behavioral: Higher frequency, shorter period of Tai Chi Chuan12 weeks of Tai Chi Chuan, 5x/week |
| Tai Chi Chuan Group3 | Experimental | Behavioral: Lower frequency, longer period of Tai Chi Chuan24 weeks of Tai Chi Chuan, 3x/week |
| Tai Chi Chuan Group4 | Experimental | Behavioral: Higher frequency, longer period of Tai Chi Chuan24 weeks of Tai Chi Chuan, 5x/week |
| Control | Sham comparator | Behavioral: Standard Health EducationParticipants would take standard health education 0.5hour/ session, 2 sessions/month for 6 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of mild cognitive impairment, not demented;
- Age ≥ 60 years old;
- Informed consent and voluntary participation.
Key exclusion criteria (8 listed)
- Geriatric Depression Scale score ≥ 9 points;
- Cognitive impairment caused by other reasons, taking drugs, poisoning, etc;
- Suffer from severe musculoskeletal system diseases and other contraindications to exercise and are not suitable for Tai Chi Chuan training, such as those who suffer from stroke, Parkinson's disease, and have a history of lower limb arthritis, hip and knee joint replacement, etc;
- Patients with severe heart, liver, kidney failure, malignant tumors, and other major diseases;
- Individuals with visual/auditory impairments, writing/reading impairments, illiteracy, etc. that affect training and evaluation;
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 |
|---|---|---|
| Lower frequency, shorter period of Tai Chi ChuanParticipants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3 sessions/week for 12 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months. | Behavioural | Tai Chi Chuan Group1 |
| Higher frequency, shorter period of Tai Chi ChuanParticipants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 12 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months. | Behavioural | Tai Chi Chuan Group2 |
| Lower frequency, longer period of Tai Chi ChuanParticipants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3 sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months. | Behavioural | Tai Chi Chuan Group3 |
| Higher frequency, longer period of Tai Chi ChuanParticipants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months. | Behavioural | Tai Chi Chuan Group4 |
| Standard Health EducationParticipants would take standard health education 0.5 hour/ session, 2 sessions/month for 6 months. | Behavioural | Control |
Primary outcome
Montreal Cognitive Assessment
Time frame: 12 weeks, 24 weeks
Global cognition
8 secondary outcomes
Montreal Cognitive Assessment
Time frame: 52 weeks
Wechsler Memory Scale
Time frame: 12 weeks, 24 weeks and 52 weeks
Digit Symbol Substitution Test
Time frame: 12 weeks, 24 weeks and 52 weeks
Trial Making Test part B
Time frame: 12 weeks, 24 weeks and 52 weeks
Stroop Color Word Test
Time frame: 12 weeks, 24 weeks and 52 weeks
Boston Naming Test
Time frame: 12 weeks, 24 weeks and 52 weeks
Rey-Osterrieth Complex Graphics Test
Time frame: 12 weeks, 24 weeks and 52 weeks
Rey Auditory Verbal Learning Test
Time frame: 12 weeks, 24 weeks and 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lower frequency, shorter period of Tai Chi Chuan, Higher frequency, shorter period of Tai Chi Chuan and Lower frequency, longer period of Tai Chi Chuan in people with Mild Cognitive Impairment, run by Lidian Chen.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Montreal Cognitive Assessment (time frame: 12 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.