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

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Secondary Prevention of Coronary Heart Disease

Treatments: Combination Product: AI-Enabled Stratified Management System; Combination Product: Usual post-discharge care

Study type: Interventional

Funder types: Other

Identifiers

NCT07259278

2024-I2M-C&T-B-040

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

AI-Enabled Stratified Management Group

Experimental group

Description:

Participants in the intervention group will receive comprehensive post-hospital rehabilitation management through an AI-based stratified management platform, utilizing a smartphone app and wearable device to track health data, deliver reminders and immediate safety alerts.

Treatment:

Combination Product: Usual post-discharge care

Combination Product: AI-Enabled Stratified Management System

Standard Post-Discharge Care Group

Active Comparator group

Description:

Participants in the control group will receive usual discharge protocol and personalized exercise prescription and goals from a specialist.

Treatment:

Combination Product: Usual post-discharge care