Intelligent Management Platform for Guiding Exercise Rehabilitation in Coronary Heart Disease Patients

Официальное название

Artificial Intelligence-enhanced Stratified Management Platform Guiding Home-based Exercise Rehabilitation for Coronary Heart Disease Patients: a Randomized Control Trial

Обзор

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: 1. Does using the AI platform lead to a greater improvement in exercise capacity (measured by peak oxygen consumption, VO2peak) after 3 months? 2. Does the platform help increase daily physical activity, improve exercise adherence and motivation, and better control modifiable cardiovascular risk factors? 3. 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: 1. Be randomly assigned to either use the AI platform or receive usual post-discharge care. 2. Receive a personalized exercise prescription from a doctor before going home. 3. 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. 4. 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.

Вмешательства

• Комбинированный продукт AI-Enabled Stratified Management System
  Following discharge, participants in the AI-stratified management group will use an intelligent platform (smartphone app + wearable divice) for home-based exercise rehabilitation and comprehensive post-discharge care. Key features include: 1) Safety Monitoring \& Alerts: Real-time tracking of heart rate and other parameters via wristband triggers immediate safety warnings during exercise; 2) Holistic Risk Management: Integrated support for lifestyle modification, medication adherence, and contro
• Комбинированный продукт Usual post-discharge care
  Usual discharge protocol comprising verbal and printed discharge instructions addressing medication schedules, follow-up timelines, and lifestyle optimization strategies as well as a personalized exercise prescription.

Первичные конечные точки

• Peak oxygen consumption (VO2peak) [Срок оценки: From enrollment to the end of treatment at 3 months.]

Вторичные конечные точки (12)

• Change in 6-minute walk distance [Срок оценки: From enrollment to the end of treatment at 3 months]
• Change in physical activity level (MET-min/week) [Срок оценки: From enrollment to the end of treatment at 3 months]
• Change in average daily step count [Срок оценки: From enrollment to the end of treatment at 3 months]
• Exercise adherence [Срок оценки: From enrollment to the end of treatment at 3 months.]
• Composite endpoints [Срок оценки: From enrollment to the end of treatment at 3 months]
• Systolic blood pressure (mmHg) [Срок оценки: From enrollment to the end of treatment at 3 months]
• Diastolic blood pressure (mmHg) [Срок оценки: From enrollment to the end of treatment at 3 months]
• Glycated hemoglobin (HbA1c, %) [Срок оценки: From enrollment to the end of treatment at 3 months]
• Low-density lipoprotein cholesterol (LDL-C, mmol/L) [Срок оценки: From enrollment to the end of treatment at 3 months]
• Body mass index (BMI, kg/m^2) [Срок оценки: From enrollment to the end of treatment at 3 months]
• Unplanned rehospitalization due to cardiovascular causes [Срок оценки: From enrollment to the end of treatment at 3 months]
• Major Adverse Cardiovascular Events (MACE) [Срок оценки: From enrollment to the end of treatment at 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Dis — Пекин

Идентификаторы

NCT: NCT07259278 · 2024-I2M-C&T-B-040

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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