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

NCT07608510 | Not Yet Recruiting DMC

• 1 other identifier: FujianUTCM-2026-001
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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 cognitive benefit population characteristics and individualized dose prescription) in a real-world community-dwelling population.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

mild cognitive impairment; taiji; machine learning; External Validation; Real-World Study

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment

  Global cognition

  Single cross-sectional assessment at the time of study enrollment (baseline visit)

Secondary Outcomes (7)

• Wechsler Memory Scale

  Single cross-sectional assessment at the time of study enrollment (baseline visit)

• Digital Symbol test

  Single cross-sectional assessment at the time of study enrollment (baseline visit)

• Trial Making Test part B

  Single cross-sectional assessment at the time of study enrollment (baseline visit)

• Stroop color word test

  Single cross-sectional assessment at the time of study enrollment (baseline visit)

• Boston naming test

  Single cross-sectional assessment at the time of study enrollment (baseline visit)

Other Outcomes (6)

• Blood glucose metabolism index

  Single cross-sectional assessment at the time of study enrollment (baseline visit)

• Blood lipid metabolism index

  Single cross-sectional assessment at the time of study enrollment (baseline visit)

• Resting-State Functional Magnetic Resonance Imaging: Default Mode Network Functional Connectivity Structural Magnetic Resonance Imaging: Hippocampal Volume

  Single cross-sectional assessment at the time of study enrollment (baseline visit)

Study Arms (1)

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.

Behavioral: 24-form Simplified Tai Chi (Observational Behavioral Exposure)

Interventions

24-form Simplified Tai Chi (Observational Behavioral Exposure) BEHAVIORAL

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.

Cross-Sectional External Validation Cohort

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \. 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Lidian Chen: lead
• Peking University Third Hospital: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

APOE Genotype

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: May 27, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-04