Effect of Mobile-Based Home Cardiac Rehabilitation on Coronary Plaque (MHCRT)

June 16, 2026 updated by: China National Center for Cardiovascular Diseases

Effect of Mobile Internet Technology-Based Home Cardiac Rehabilitation on Coronary Artery Plaque in Patients With Mild to Moderate Stenosis

This single-center, randomized controlled trial aims to evaluate the efficacy of a mobile internet-based, home-based cardiac rehabilitation program in patients with mild to moderate coronary artery stenosis. A total of 176 eligible participants will be randomized to receive either a personalized lifestyle intervention via a mobile platform or routine clinical care. The primary endpoint is the change in non-calcified coronary plaque volume, as measured by coronary computed tomography angiography (CTA) at 12 months. Participants will be followed for a total of 36 months to comprehensively assess the long-term impact of this digital lifestyle intervention on plaque progression and cardiovascular outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1.Diagnosis of mild-to-moderate coronary artery stenosis: presence of plaque in any coronary artery causing mild (<50%) or moderate (50%-69%) luminal stenosis.

    2.Age between 18 and 70 years. 3.Asymptomatic during exercise or recovery phases of cardiopulmonary assessment, including absence of angina, ST-segment depression, or complex arrhythmias at rest or during exercise.

    4.Normal troponin levels. 5.Provided signed informed consent.

Exclusion Criteria:

  • 1. Severe coronary artery stenosis. 2.Presence of severe respiratory or cardiovascular diseases (e.g., acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis).

    3.Angina symptoms or signs during low-intensity exercise (<5 METs) or recovery. 4.Complex arrhythmias at rest or during exercise. 5.Hemodynamic abnormalities during exercise (e.g., failure of systolic blood pressure or heart rate to increase, or a decrease in blood pressure with increased exercise workload).

    6.Severe psychological disorders. 7.Left ventricular ejection fraction (LVEF) < 40%. 8.Elevated troponin levels. 9.Inability to undergo cardiopulmonary exercise testing due to neuromuscular or musculoskeletal disorders.

    10.Presence of other severe comorbidities. 11.Refusal to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Participants receiving the home-based cardiac rehabilitation program via a mobile application.
Behavioral: mHealth-based Cardiac Rehabilitation Program
The intervention is a comprehensive, personalized cardiac rehabilitation program delivered via a mobile health (mHealth) platform. It consists of three core components: (1) Exercise Prescription: Personalized training plans aiming for 150 minutes of moderate-intensity aerobic exercise per week, combined with strength and flexibility training. (2) Nutritional Guidance: An initial offline nutritional assessment and personalized meal planning, followed by monthly online follow-ups and adjustments. (3) Psychological Support: Motivational interviewing and targeted psychological interventions provided as needed. Additionally, the program utilizes the mHealth platform to provide weekly online community supervision, progress tracking, and continuous health education to enhance patient compliance and engagement.
No Intervention: Control Group
Participants receiving usual care and general health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chang in non-calcified plaque volume
Time Frame: Baseline and 12 months
The change in non-calcified plaque volume will be assessed and quantified using Coronary Computed Tomography Angiography (CCTA).
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-GSP-TS-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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