Effect of Mobile-Based Home Cardiac Rehabilitation on Coronary Plaque
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChina National Center for Cardiovascular Diseases
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
mHealth-based Cardiac Rehabilitation Program
BehavioralThe 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.
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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).
Time frame
Baseline and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov