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NCT Number: NCT07259278

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Prof. Gao, MD, PhD

CONTACT

[email protected]

010-88322413

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Peak oxygen consumption (VO2peak)

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

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

Secondary outcomes

  1. Change in 6-minute walk distance

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

    6-minute walk distance (m)

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

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

    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.

  3. Change in average daily step count

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

    Average daily step count (steps per day)

  4. Exercise adherence

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

    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.

  5. Composite endpoints

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

    A composite endpoint including all-cause mortality, cardiac arrest, non-fatal myocardial infarction, and symptom-driven unplanned rehospitalization occurring during exercise. Safety endpoint during rehabilitation.

  6. Systolic blood pressure (mmHg)

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

    Systolic blood pressure. Unit of Measure: mmHg.

  7. Diastolic blood pressure (mmHg)

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

    Diastolic blood pressure. Unit of Measure: mmHg.

  8. Glycated hemoglobin (HbA1c, %)

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

    Glycated hemoglobin. Unit of Measure: %.

  9. Low-density lipoprotein cholesterol (LDL-C, mmol/L)

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

    Unit of Measure: mmol/L

  10. Body mass index (BMI, kg/m^2)

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

  11. Unplanned rehospitalization due to cardiovascular causes

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

  12. Major Adverse Cardiovascular Events (MACE)

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

    Major Adverse Cardiovascular Events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.

  13. Anxiety level by Generalized Anxiety Disorder-7 scale score

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

    Anxiety level, assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Patients will be evaluated at the beginning and at the endpoint of the study with the self-administered GAD-7 scale. The GAD-7 scale score ranges from 0 to 21 points. A score between 5 and 9 points characterizes mild GAD. Between 10 and 14, moderate GAD and between 15 and 21, severe GAD.

  14. Depression level by Patient Health Questionnaire-9 (PHQ-9)

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

    Depression level, assessed using the Patient Health Questionnaire-9 (PHQ-9). The GAD-7 scale score ranges from 0 to 27 points. A score between 5 and 9 points characterizes mild depression. Between 10 and 14, moderate depression; between 15 and 19, moderate-severe depression; and between 20 and 27, severe depression.

  15. Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI)

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

    Sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21 with a higher score indicating poor quality of sleep (worse). The higher the score, the worse the sleep quality. A cut-off score of >5 indicates poor sleep quality.

  16. Quality of life by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire

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

    Quality of life, assessed using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire. This questionnaire asks 5 multiple-choice questions about mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. EQ-5D-5L index scores range from 0 to 100, where 100 is the best possible health state.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Gao, MD, PhD

CONTACT

[email protected]

010-88322413

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

  • Chinese Academy of Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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