Research on the Mechanisms and Intervention Strategies for Physical Activity Promotion in Frail Patients With Cardiovascular-Kidney-Metabolic Syndrome From a Temporal Self-Regulation Perspective
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 614
- 主要终点
- Consideration of Future Consequences Scale (CFC-S)
研究概览
简要总结
Longitudinal physical activity data and associated factors were collected at baseline (diagnosis), 3-month, 6-month, and 9-month follow-ups in cardiovascular-kidney-metabolic syndrome patients.
详细描述
This study targets the frail population with early-middle-age CKM syndrome. Grounded in the Time-limited Self-regulation Theory (TST), it employs behavioral data analysis, theoretical variable modeling, and intervention strategy development to systematically identify risk trajectories and influencing pathways of physical activity (PA) insufficiency, thereby formulating stratified and classified intervention strategies to enhance PA levels. The research comprises three key components:
Research Component 1: Risk Prediction Model for PA Insufficiency in Frail CKM Syndrome Patients Early-middle-age frail CKM syndrome patients exhibit significant PA insufficiency and behavioral variability at the disease onset. Early identification of PA evolution trends and high-risk groups is crucial for timely intervention and precise resource allocation.
Objective:
To determine "who is more likely to sustain PA insufficiency" by constructing a trajectory identification model and risk prediction tool using longitudinal data, analyzing dynamic PA behavior patterns, and quantifying multifactorial risk probabilities to support subsequent intervention mechanisms and strategy classification.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥45 years and <60 years;
- •Frailty status assessed by Fried phenotype criteria, including those diagnosed with frailty or pre-frailty;
- •Meeting AHA guideline criteria for Stage 1-2 CKM syndrome (diagnostic details in Table 1);
- •Ability to communicate normally and use smartphones or wearable devices;
- •Willingness to participate in surveys and follow-up;
- •Additional Note on PREVENT Equation:
- •The PREVENT equation, developed by the American Heart Association (AHA), is a cardiovascular disease (CVD) risk prediction tool. It calculates 10-year CVD risk based on:
- •Total cholesterol, HDL-C
- •Systolic blood pressure, BMI
- •History of diabetes, smoking
- •Use of antihypertensive or lipid-lowering medications
排除标准
- •Severe cognitive impairment (e.g., MMSE score <10 or clinical dementia diagnosis);
- •Severe psychiatric/psychological disorders (e.g., schizophrenia, major depressive disorder with suicidal ideation);
- •Advanced chronic diseases including:
- •End-stage renal disease (eGFR <15 mL/min/1.73m² or on dialysis)
- •Metastatic cancer (stage IV per AJCC criteria)
- •Cardiorespiratory insufficiency (NYHA Class III-IV heart failure or COPD GOLD Stage D)
- •Severe osteoarthritis (Kellgren-Lawrence Grade 4 with functional limitation)
- •Major surgery or acute illness within 3 months (e.g., myocardial infarction, stroke, or major trauma requiring hospitalization);
- •Physical disabilities impairing mobility (e.g., amputation, paralysis, or severe Parkinsonism with Hoehn & Yahr Stage ≥3).
结局指标
主要结局
Consideration of Future Consequences Scale (CFC-S)
时间窗: Baseline , 3 months, 6 months, 9 months
The Consideration of Future Consequences Scale (CFC-S), developed by Strathman et al., includes two dimensions: consideration of the present (items 3, 4, 5, 9, 10, 11, 12) and consideration of the future (items 1, 2, 6, 7, 8). The Chinese version was cross-culturally adapted by Feng Jiaxi et al. The scale includes 12 items, rated on a 7-point Likert scale, where 1 means "not at all like me" and 7 means "exactly like me." Internal consistency coefficients in elderly populations are 0.71 and 0.80 for the two dimensions, and split-half reliability is 0.69 and 0.78, indicating good psychometric properties.
Global Physical Activity Questionnaire (GPAQ)
时间窗: Baseline , 3 months, 6 months, 9 months
It includes four domains: work, transportation, recreation, and sedentary behavior. The questionnaire assesses the participant's PA in these four areas over the course of a week. PA in the work and recreation domains is further classified into vigorous and moderate levels. The questionnaire contains 16 items, and only activities lasting more than 10 minutes are considered relevant PA.The higher the activity intensity, the greater the MET value, meaning the body consumes more energy. High PA Level: At least three days of vigorous-intensity activity per week, with a total MET value of at least 1500 METs, or daily moderate-to-vigorous activity with a total MET value of at least 3000 METs per week. Moderate PA Level: At least three days of vigorous-intensity activity per week.Low PA Level: Insufficient activity, where the individual does not meet the moderate-to-vigorous intensity activity standard.
次要结局
- Monetary Choice Questionnaire (MCQ)(Baseline , 3 months, 6 months, 9 months)
- Exercise Benefits/Barriers Scale (EBBS)(Baseline , 3 months, 6 months, 9 months)
- Multidimensional Frailty(baseline)
- Charlson Comorbidity Index (CCI)(baseline)
- Intentions(Baseline , 3 months, 6 months, 9 months)
- Self-Report Habit Index (SRHI)(Baseline , 3 months, 6 months, 9 months)
- Healthy Neighborhood Survey for Community-Dwelling Older Adults(Baseline , 3 months, 6 months, 9 months)
- Brief Self-Control Scale (BSCS)(Baseline , 3 months, 6 months, 9 months)
研究者
Zhongmin Fu
Principal Investigator
Nanjing Medical University