NCT07259278招募中不适用
Artificial Intelligence-enhanced Stratified Management Platform Guiding Home-based Exercise Rehabilitation for Coronary Heart Disease Patients: a Randomized Control Trial
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Peak oxygen consumption (VO2peak)
研究概览
简要总结
The goal of this clinical trial is to find out if an artificial intelligence (AI)-enabled stratified management platform can help adults with coronary heart disease (CHD) better perform exercise rehabilitation and manage their health after being discharged from the hospital. The main questions it aims to answer are:
- Does using the AI platform lead to a greater improvement in exercise capacity (measured by peak oxygen consumption, VO2peak) after 3 months?
- Does the platform help increase daily physical activity, improve exercise adherence and motivation, and better control modifiable cardiovascular risk factors?
- Is guiding home-based exercise with this platform safe for low-risk CHD patients?
Researchers will compare the AI Management Group (using the platform and a sports wristband) to the Routine Management Group (receiving usual care without the platform) to see if the AI group shows more significant improvements in fitness and health metrics.
Participants will:
- Be randomly assigned to either use the AI platform or receive usual post-discharge care.
- Receive a personalized exercise prescription from a doctor before going home.
- If in the AI group: Use the smartphone app and wearable device to track health data for comprehensive post-discharge management, and receive reminders and immediate safety alerts.
- Attend a follow-up visit at 3 months for check-ups and tests, including an exercise test and health assessments.
The study hopes to show that this intelligent management platform is an effective and safe tool to help people with CHD recover at home, stay active, and reduce future heart risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHD patients aged over 18 years;
- •Stratified as low-risk for cardiovascular events during exercise and classified as low-risk according to the GRACE risk score.
- •Ability of the patient or close relatives to use smartphones and applications;
- •Willingness to participate and sign the informed consent form.
排除标准
- •Residual stenosis of >50% in the left main coronary artery, or >70% stenosis in other major epicardial vessels;
- •Planned coronary revascularization within the next 3 months;
- •Acute myocardial infarction within the past 1 month;
- •Severe cognitive impairment;
- •Severely impaired exercise capacity.
- •Advanced-stage malignancy;
- •Life expectancy less than 3 months;
- •Severe multi-organ failure;
- •Other conditions deemed unsuitable for home-based exercise rehabilitation following assessment by a specialist rehabilitation physician.
- •Refusal to provide written informed consent.
结局指标
主要结局
Peak oxygen consumption (VO2peak)
时间窗: From enrollment to the end of treatment at 3 months.
Peak oxygen consumption (VO2peak, mL∙kg-¹min-¹)
次要结局
- Change in average daily step count(From enrollment to the end of treatment at 3 months)
- Exercise adherence(From enrollment to the end of treatment at 3 months.)
- Composite endpoints(From enrollment to the end of treatment at 3 months)
- Systolic blood pressure (mmHg)(From enrollment to the end of treatment at 3 months)
- Diastolic blood pressure (mmHg)(From enrollment to the end of treatment at 3 months)
- Change in 6-minute walk distance(From enrollment to the end of treatment at 3 months)
- Change in physical activity level (MET-min/week)(From enrollment to the end of treatment at 3 months)
- Unplanned rehospitalization due to cardiovascular causes(From enrollment to the end of treatment at 3 months)
- Glycated hemoglobin (HbA1c, %)(From enrollment to the end of treatment at 3 months)
- Low-density lipoprotein cholesterol (LDL-C, mmol/L)(From enrollment to the end of treatment at 3 months)
- Body mass index (BMI, kg/m^2)(From enrollment to the end of treatment at 3 months)
- Major Adverse Cardiovascular Events (MACE)(From enrollment to the end of treatment at 3 months)
- Anxiety level by Generalized Anxiety Disorder-7 scale score(From enrollment to the end of treatment at 3 months)
- Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI)(From enrollment to the end of treatment at 3 months)
- Depression level by Patient Health Questionnaire-9 (PHQ-9)(From enrollment to the end of treatment at 3 months)
- Quality of life by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire(From enrollment to the end of treatment at 3 months)
研究者
研究点 (1)
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