Effect of Mobile-Based Home Cardiac Rehabilitation on Coronary Plaque
MHCRT
Effect of Mobile Internet Technology-Based Home Cardiac Rehabilitation on Coronary Artery Plaque in Patients With Mild to Moderate Stenosis
1 other identifier
interventional
176
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2024
CompletedFirst Submitted
Initial submission to the registry
June 16, 2026
CompletedFirst Posted
Study publicly available on registry
June 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
June 22, 2026
June 1, 2026
2 years
June 16, 2026
June 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
chang in non-calcified plaque volume
The change in non-calcified plaque volume will be assessed and quantified using Coronary Computed Tomography Angiography (CCTA).
Baseline and 12 months
Study Arms (2)
Experimental Group
EXPERIMENTALParticipants receiving the home-based cardiac rehabilitation program via a mobile application.
Control Group
NO INTERVENTIONParticipants receiving usual care and general health education
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of mild-to-moderate coronary artery stenosis: presence of plaque in any coronary artery causing mild (\<50%) or moderate (50%-69%) luminal stenosis.
- 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.
- Normal troponin levels. 5.Provided signed informed consent.
You may not qualify if:
- \. Severe coronary artery stenosis. 2.Presence of severe respiratory or cardiovascular diseases (e.g., acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis).
- 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).
- 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.
- Presence of other severe comorbidities. 11.Refusal to sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2026
First Posted
June 22, 2026
Study Start
December 31, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
June 22, 2026
Record last verified: 2026-06