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
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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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. -
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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. |
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Montreal Cognitive Assessment
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Global cognition
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Wechsler Memory Scale
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Memory function
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Digital Symbol test
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Attention
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Trial Making Test part B
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Executive function
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Stroop color word test
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Processing speed
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Boston naming test
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Verbal fluency
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Rey-Osterrieth complex graphics test
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Rey Auditory Verbal Learning Test
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Episodic memory
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Blood glucose metabolism index
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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fasting blood glucose
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Blood lipid metabolism index
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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total cholesterol (TC), total triglyceride (TG), low density lipoprotein (LDL), high density lipoprotein (HDL)
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Resting-State Functional Magnetic Resonance Imaging: Default Mode Network Functional Connectivity Structural Magnetic Resonance Imaging: Hippocampal Volume
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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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)
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Core Peripheral Blood Biomarkers for Mild Cognitive Impairment (MCI)
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Amyloid-beta(Aβ)、phosphorylated tau(p-tau)、Neurofilament light chain(NfL)、Glial fibrillary acidic protein(GFAP)
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Pittsburgh Sleep Quality Index, PSQI
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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Sleep Quality
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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12-Item Short Form Health Survey
時間枠：Single cross-sectional assessment at the time of study enrollment (baseline visit)
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General health
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Single cross-sectional assessment at the time of study enrollment (baseline visit)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。