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.
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.
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;
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.
Other
Cross-sectional
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.
Montreal Cognitive Assessment
Global cognition
Wechsler Memory Scale
Memory function
Digital Symbol test
Attention
Trial Making Test part B
Executive function
Stroop color word test
Processing speed
Blood glucose metabolism index
fasting blood glucose
Blood lipid metabolism index
total cholesterol (TC), total triglyceride (TG), low density lipoprotein (LDL), high density lipoprotein (HDL)
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.
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)
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Lidian Chen
Lead sponsor
Fujian University of Traditional Chinese Medicine
Sponsor institution
Peking University Third Hospital
Collaborator
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