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

Official title

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

Overview

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.

Interventions

• Combination product 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
• 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.

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

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

Identifiers

NCT: NCT07259278 · 2024-I2M-C&T-B-040

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗