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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-Enabled Stratified Management System

    Combination product

    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 control of cardiovascular risk factors; 3) Structured Engagement: Multi-channel reminders (messages, alarms, voice calls) for medications, exercise, and follow-ups to sustain adherence.

  • Usual post-discharge care

    Combination product

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: AI-Enabled Stratified Management GroupExperimental treatment 2 interventions
Group B: Standard Post-Discharge Care GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak oxygen consumption (VO2peak)

Peak oxygen consumption (VO2peak, mL∙kg-¹min-¹)

Time frame
From enrollment to the end of treatment at 3 months.

Secondary outcomes

1

Change in 6-minute walk distance

6-minute walk distance (m)

Time frame
From enrollment to the end of treatment at 3 months
2

Change in physical activity level (MET-min/week)

Physical activity level (MET-min/week), estimated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). It consists of 7 questions with a recall period defined as 'last week'. The questions of the scale ask whether the participant walks for at least 10 minutes on any given day or does moderate or vigorous activities, and how much time/day the individual spends on each of these activities or sit.

Time frame
From enrollment to the end of treatment at 3 months
3

Change in average daily step count

Average daily step count (steps per day)

Time frame
From enrollment to the end of treatment at 3 months
4

Exercise adherence

In the self-reported exercise diary, the participant will note the number of exercises done at home. The percentage adherence to the prescribed exercise regimen was calculated by dividing the number of exercises performed by the number of exercises prescribed and multiplying by 100.

Time frame
From enrollment to the end of treatment at 3 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Chinese Academy of Medical Sciences

Collaborator