Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University Third Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment | Global cognition | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Memory Scale | Memory function | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| Digital Symbol test | Attention |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose metabolism index | fasting blood glucose | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| Blood lipid metabolism index | total cholesterol (TC), total triglyceride (TG), low density lipoprotein (LDL), high density lipoprotein (HDL) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
APOE Genotype
|
| Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| Trial Making Test part B | Executive function | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| Stroop color word test | Processing speed | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| Boston naming test | Verbal fluency | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| Rey-Osterrieth complex graphics test | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| Rey Auditory Verbal Learning Test | Episodic memory | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| 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 | 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. | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| Core Peripheral Blood Biomarkers for Mild Cognitive Impairment (MCI) | Amyloid-beta(Aβ)、phosphorylated tau(p-tau)、Neurofilament light chain(NfL)、Glial fibrillary acidic protein(GFAP) | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| Pittsburgh Sleep Quality Index, PSQI | Sleep Quality | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| 12-Item Short Form Health Survey | General health | Single cross-sectional assessment at the time of study enrollment (baseline visit) |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided