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
- Sponsor
- Lidian Chen
- Study ID
- NCT07608510
- Status
- Not Yet Recruiting
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Conditions
- Mild Cognitive Impairment (MCI)
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 24-form Simplified Tai Chi (Observational Behavioral Exposure) — BEHAVIORALThis 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 Details
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.
Key Dates
- First listed
- May 27, 2026
- Start date
- May 15, 2026
- Status verified
- Apr 2026
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 150 participants (estimated)
Arms
- Arm: Cross-Sectional External Validation CohortThis 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.
Primary Outcome Measure
Montreal Cognitive Assessment [ Time Frame: Single cross-sectional assessment at the time of study enrollment (baseline visit) ]
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