Mild Cognitive Impairment (MCI)NCT07608510
Validation of Population Characteristics and Dosage Prescriptions for Cognitive Function Intervention Benefits of Different Doses of Tai Chi in Elderly Patients With Mild Cognitive Impairment: A Real-World Cross-Sectional Study
An observational study of Mild Cognitive Impairment (MCI), run by Lidian Chen.
Trial summary
This is a companion real-world external validation study of two pre-registered parent randomized controlled trials (RCTs, protocol IDs: FujianUTCM-1 and FujianUTCM-2). We aim to validate the generalizability and clinical applicability of a pre-developed machine learning prediction model (for Tai Chi intervention… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- 24-form Simplified Tai Chi (Observational Behavioral Exposure)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: This cross-sectional real-world external validation study will enroll 150 community-dwelling older adults aged 60 years and above, who are diagnosed with Mild Cognitive Impairment (MCI) and have regular practice of standardized 24-form simplified Tai Chi for at least 6 months (consistent with the form used in the parent RCTs). Eligible participants will be recruited from communities in Fuzhou, China, to validate the generalizability and clinical applicability of a pre-developed machine learning prediction model for Tai Chi cognitive benefit population identification.
Who may be able to join
- 1. Presence of mild cognitive impairment, not demented; 2. Age ≥ 60 years old; 3.Regular practice of standardized 24-form simplified Tai Chi for at least 6 months (consistent with the form used in the parent randomized controlled trials [RCTs]) ; 4.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 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. -
About this study
Official title: Real-World External Validation Study on Beneficiary Population Characteristics and Individualized Dose Prescription for Cognitive Improvement of Tai Chi Intervention in Elderly Patients With Mild Cognitive Impairment
This is a companion real-world external validation study of two pre-registered parent randomized controlled trials (RCTs, protocol IDs: FujianUTCM-1 and FujianUTCM-2). We aim to validate the generalizability and clinical applicability of a pre-developed machine learning prediction model (for Tai Chi intervention cognitive benefit population characteristics and individualized dose prescription) in a real-world community-dwelling population.
Read the detailed description
Mild Cognitive Impairment (MCI) represents a critical early intervention window for delaying the onset and progression of dementia, and early non-pharmacological intervention has become an international consensus in this field. Our research team has completed two multicenter interventional randomized controlled trials (RCTs) pre-registered on ClinicalTrials.gov and their companion multicenter RCTs. Both studies adopted the standardized 24-form simplified Tai Chi as the intervention, with highly unified intervention procedures, movement specifications, and dose settings. These trials confirmed the dose-response relationship of Tai Chi intervention on cognitive improvement in older adults with MCI due to Alzheimer's disease, and preliminarily clarified the intervention effects of different Tai Chi dose combinations on patients' global cognition and cognitive subdomains.
On this basis, we will further identify the core characteristics of the population with significant cognitive benefits from Tai Chi intervention through machine learning algorithms. Based on data mining from 890 RCT participants, we will construct a dual-function machine learning prediction model for "beneficiary population identification + individualized Tai Chi dose prescription formulation". However, the above conclusions are all derived from standardized RCT settings, and their generalizability and clinical applicability in real-world community settings have not yet been validated.
As a sequential validation study, this research will conduct a cross-sectional survey by enrolling 150 older adults with long-term regular Tai Chi practice from communities in Fuzhou, China, to complete two-dimensional external validation of the previous RCT findings: to verify the consistency and feasibility between the beneficiary population characteristics and corresponding Tai Chi dose prescriptions mined from the parent RCTs, and the real Tai Chi dose combinations of the beneficiary population in the real world.
This study will form a closed loop from "causal evidence mining in RCTs" to "clinical application validation in real-world settings", and provide direct, high-level scientific evidence for the clinical promotion and individualized application of Tai Chi intervention in older adults with MCI.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- 24-form Simplified Tai Chi (Observational Behavioral Exposure)
- Keywords
- mild cognitive impairment, taiji, machine learning, External Validation, Real-World Study
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-form Simplified Tai Chi (Observational Behavioral Exposure)Behavioural
This is the core observational exposure factor of this cross-sectional real-world external validation study, NOT an intervention actively assigned, implemented or manipulated by the investigator. This study only observes and records the existing long-term regular Tai Chi practice behavior (including dose, frequency and duration) of enrolled older adults with Mild Cognitive Impairment (MCI) during a single time-point cross-sectional survey, for the sole purpose of externally validating the generalizability of a pre-developed machine learning prediction model for Tai Chi cognitive benefit population identification and individualized dose prescription. No active behavioral intervention will be administered to any participant in this study.
| Study group | Role | What they receive |
|---|---|---|
| Cross-Sectional External Validation Cohort | This is the only study population for this cross-sectional observational real-world external validation study. The cohort consists of community-dwelling older adults aged 60 years and above, who are diagnosed with Mild Cognitive Impairment (MCI) and have long-term regular Tai Chi practice. Participants will be recruited from communities in Fuzhou, China, with a planned sample size of 150 participants.
This study will conduct a single time-point cross-sectional survey on this population, with no prospective follow-up. The sole objective is to externally validate the generalizability and clinical applicability of a pre-developed machine learning prediction model (for identifying MCI populations who gain significant cognitive benefits from Tai Chi intervention and formulating individualized Tai Chi dose prescriptions) in a real-world community setting. Receives: Behavioral: 24-form Simplified Tai Chi (Observational Behavioral Exposure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment
Global cognition
Measured: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Secondary outcomes (7)
Wechsler Memory Scale
Memory function
Measured: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Digital Symbol test
Attention
Measured: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Trial Making Test part B
Executive function
Measured: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Stroop color word test
Processing speed
Measured: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Boston naming test
Verbal fluency
Measured: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Rey-Osterrieth complex graphics test
Measured: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Rey Auditory Verbal Learning Test
Episodic memory
Measured: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start15 May 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 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
- NCT07608510
- Sponsor's protocol ID
- FujianUTCM-2026-001
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 27 May 2026
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World External Validation Study on Beneficiary Population Characteristics and Individualized Dose Prescription for Cognitive Improvement of Tai Chi Intervention in Elderly Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07608510
- Acronym / sponsor ID
- FujianUTCM-2026-001
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- mild cognitive impairment, taiji, machine learning, External Validation, Real-World Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lidian ChenUniversity, hospital or other
- Collaborators
- Peking University Third Hospital
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 May 2026 (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.
This is a companion real-world external validation study of two pre-registered parent randomized controlled trials (RCTs, protocol IDs: FujianUTCM-1 and FujianUTCM-2). We aim to validate the generalizability and clinical applicability of a pre-developed machine learning prediction model (for Tai Chi intervention cognitive benefit population characteristics and individualized dose prescription) in a real-world community-dwelling population.
Detailed description
Mild Cognitive Impairment (MCI) represents a critical early intervention window for delaying the onset and progression of dementia, and early non-pharmacological intervention has become an international consensus in this field. Our research team has completed two multicenter interventional randomized controlled trials (RCTs) pre-registered on ClinicalTrials.gov and their companion multicenter RCTs. Both studies adopted the standardized 24-form simplified Tai Chi as the intervention, with highly unified intervention procedures, movement specifications, and dose settings. These trials confirmed the dose-response relationship of Tai Chi intervention on cognitive improvement in older adults with MCI due to Alzheimer's disease, and preliminarily clarified the intervention effects of different Tai Chi dose combinations on patients' global cognition and cognitive subdomains.
On this basis, we will further identify the core characteristics of the population with significant cognitive benefits from Tai Chi intervention through machine learning algorithms. Based on data mining from 890 RCT participants, we will construct a dual-function machine learning prediction model for "beneficiary population identification + individualized Tai Chi dose prescription formulation". However, the above conclusions are all derived from standardized RCT settings, and their generalizability and clinical applicability in real-world community settings have not yet been validated.
As a sequential validation study, this research will conduct a cross-sectional survey by enrolling 150 older adults with long-term regular Tai Chi practice from communities in Fuzhou, China, to complete two-dimensional external validation of the previous RCT findings: to verify the consistency and feasibility between the beneficiary population characteristics and corresponding Tai Chi dose prescriptions mined from the parent RCTs, and the real Tai Chi dose combinations of the beneficiary population in the real world.
This study will form a closed loop from "causal evidence mining in RCTs" to "clinical application validation in real-world settings", and provide direct, high-level scientific evidence for the clinical promotion and individualized application of Tai Chi intervention in older adults with MCI.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross-Sectional External Validation Cohort | – | Behavioral: 24-form Simplified Tai Chi (Observational Behavioral Exposure)This is the only study population for this cross-sectional observational real-world external validation study. The cohort consists of community-dwelling older adults aged 60 years and above, who are diagnosed with Mild Cognitive Impairment (MCI) and have long-term regular Tai Chi practice. Participants will be recruited from communities in Fuzhou, China, with a planned sample size of 150 participants. This study will conduct a single time-point cross-sectional survey on this population, with no prospective follow-up. The sole objective is to externally validate the generalizability and clinical applicability of a pre-developed machine learning prediction model (for identifying MCI populations who gain significant cognitive benefits from Tai Chi intervention and formulating individualized Tai Chi dose prescriptions) in a real-world community setting. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional real-world external validation study will enroll 150 community-dwelling older adults aged 60 years and above, who are diagnosed with Mild Cognitive Impairment (MCI) and have regular practice of standardized 24-form simplified Tai Chi for at least 6 months (consistent with the form used in the parent RCTs). Eligible participants will be recruited from communities in Fuzhou, China, to validate the generalizability and clinical applicability of a pre-developed machine learning prediction model for Tai Chi cognitive benefit population identification.
Key inclusion criteria (1 listed)
- 1. Presence of mild cognitive impairment, not demented; 2. Age ≥ 60 years old; 3.Regular practice of standardized 24-form simplified Tai Chi for at least 6 months (consistent with the form used in the parent randomized controlled trials [RCTs]) ; 4.Informed consent and voluntary participation.
Key exclusion criteria (7 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 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 |
|---|---|---|
| 24-form Simplified Tai Chi (Observational Behavioral Exposure)This is the core observational exposure factor of this cross-sectional real-world external validation study, NOT an intervention actively assigned, implemented or manipulated by the investigator. This study only observes and records the existing long-term regular Tai Chi practice behavior (including dose, frequency and duration) of enrolled older adults with Mild Cognitive Impairment (MCI) during a single time-point cross-sectional survey, for the sole purpose of externally validating the generalizability of a pre-developed machine learning prediction model for Tai Chi cognitive benefit population identification and individualized dose prescription. No active behavioral intervention will be administered to any participant in this study. | Behavioural | Cross-Sectional External Validation Cohort |
Primary outcome
Montreal Cognitive Assessment
Time frame: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Global cognition
7 secondary outcomes
Wechsler Memory Scale
Time frame: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Digital Symbol test
Time frame: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Trial Making Test part B
Time frame: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Stroop color word test
Time frame: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Boston naming test
Time frame: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Rey-Osterrieth complex graphics test
Time frame: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Rey Auditory Verbal Learning Test
Time frame: Single cross-sectional assessment at the time of study enrollment (baseline visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment (MCI), 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 1 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 May 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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: Single cross-sectional assessment at the time of study enrollment (baseline visit)). 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 27 May 2026.