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NCT Number: 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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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. -

Treatment and study plan

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.

Primary outcomes

  1. Montreal Cognitive Assessment

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

    Global cognition

Secondary outcomes

  1. Wechsler Memory Scale

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

    Memory function

  2. Digital Symbol test

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

    Attention

  3. Trial Making Test part B

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

    Executive function

  4. Stroop color word test

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

    Processing speed

  5. Boston naming test

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

    Verbal fluency

  6. Rey-Osterrieth complex graphics test

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

  7. Rey Auditory Verbal Learning Test

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

    Episodic memory

Other outcomes

  1. Blood glucose metabolism index

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

    fasting blood glucose

  2. Blood lipid metabolism index

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

    total cholesterol (TC), total triglyceride (TG), low density lipoprotein (LDL), high density lipoprotein (HDL)

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

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

    Resting-State Functional Magnetic Resonance Imaging (rs-fMRI) Measurement of Default Mode Network Functional Connectivity Strength Resting-state fMRI (rs-fMRI) data will be acquired using a 3.0T scanner to evaluate default mode network (DMN) functional connectivity strength, a key correlate of cognitive function. All scanning parameters, preprocessing and analysis methods are identical to our parent randomized controlled trials (FujianUTCM-1/2). Data processing uses SPM12 and CONN toolbox.

    3.0T Three-Dimensional T1-Weighted Structural MRI (sMRI) Measurement of Bilateral Hippocampal Total Volume 3D T1-weighted structural MRI (sMRI) data will be acquired using a 3.0T scanner to quantify bilateral hippocampal total volume. All scanning parameters, preprocessing and volumetric analysis methods are consistent with our parent randomized controlled trials (FujianUTCM-1/2). Automated segmentation uses FreeSurfer 7.4.1 with manual visual correction.

  4. Core Peripheral Blood Biomarkers for Mild Cognitive Impairment (MCI)

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

    Amyloid-beta(Aβ)、phosphorylated tau(p-tau)、Neurofilament light chain(NfL)、Glial fibrillary acidic protein(GFAP)

  5. Pittsburgh Sleep Quality Index, PSQI

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

    Sleep Quality

  6. 12-Item Short Form Health Survey

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

    General health

Sponsors and collaborators

Lead sponsor

Lidian Chen

Other

Collaborators

  • Peking University Third Hospital

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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