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

NCT ID: NCT07259278

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Secondary Prevention of Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AI-Enabled Stratified Management Group

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.

Group Type EXPERIMENTAL

AI-Enabled Stratified Management System

Intervention Type 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

Intervention Type 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.

Standard Post-Discharge Care Group

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

Group Type ACTIVE_COMPARATOR

Usual post-discharge care

Intervention Type 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.

Interventions

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

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuwai Hospital, Chinese Academy of Medical Sciences/National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Prof. Gao, MD, PhD

Role: CONTACT

010-88322413

Facility Contacts

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Prof. Gao, MD, PhD

Role: primary

010-88322413

Other Identifiers

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2024-I2M-C&T-B-040

Identifier Type: -

Identifier Source: org_study_id

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