Effectiveness of Digital Cardiac Rehabilitation on Functional Capacity in Patients With Myocardial Infarction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-65
SponsorCairo University
About this trial
The goal of this clinical trial is to learn if a digital health-supported cardiac rehabilitation program works to improve functional capacity, adherence, quality of life, and psychological status in cardiac patients. It will also learn about the effect of digital health support when added to conventional outpatient cardiac rehabilitation.
The main questions it aims to answer are:
Does a digital health-supported cardiac rehabilitation program improve functional capacity?
How does digital health support affect patients' adherence to cardiac rehabilitation?
How does the program affect patients' quality of life and psychological status?
Researchers will compare digital health-supported cardiac rehabilitation combined with conventional outpatient cardiac rehabilitation to conventional outpatient cardiac rehabilitation alone to determine whether digital support improves functional, behavioral, and psychological outcomes in phase II cardiac patients.
Participants will:
Be randomly assigned to receive either digital health-supported hybrid cardiac rehabilitation in addition to conventional outpatient cardiac rehabilitation or conventional outpatient cardiac rehabilitation alone.
Have their functional exercise capacity assessed using the Six-Minute Walk Test (6MWT) as the primary outcome measure.
Complete assessments to evaluate cardiac rehabilitation adherence and engagement, health-related quality of life, and psychological status.
Have resting heart rate and blood pressure monitored as part of the clinical assessment.
Participants in the digital health-supported group will also use digital health tools for activity monitoring, exercise adherence, reminders, education, communication, and weekly telecoaching.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women aged 55-65 years.
Medically stable patients with a documented history of myocardial infarction who have been referred for Phase II outpatient cardiac rehabilitation.
Body mass index (BMI) between 30.0 and 39.9 kg/m² (Obesity Classes I and II).
Clearance from a cardiologist to participate in the prescribed exercise program.
Disqualifiers
Unstable angina or decompensated heart failure.
Uncontrolled arrhythmias, uncontrolled hypertension, or any other contraindication to exercise training.
A recent major cardiac event or intervention that has not yet been medically stabilized.
Severe orthopedic, neurological, or pulmonary conditions that limit exercise testing or training.
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Treatment group
Procedure/SurgeryDuration \& Frequency: A 12-week supervised program with 3 sessions per week for both groups. Session Structure: Warm-up (5-10 min): Low-intensity stretching and rhythmic movements. Aerobic Training (20-40 min): Treadmill exercise prescribed at 40%-60% Heart Rate Reserve (HRR) using the Karvonen formula. Precision Intensity Target: HR{max} is derived from a symptom-limited exercise stress test (rather than age-predicted formulas) to keep intensity safely below the patient's ischemic or symptomatic threshold. Resistance \& Cool-down: Major muscle group resistance training (1-2 sets of 10-15 reps), cool-down exercises, and breathing techniques. Patient Education: Covers risk-factor modification, medication adherence (e.g., beta-blockers), nutrition, and smoking cessation for secondary prevention.
Digital and Conventional treatment
Procedure/SurgeryTreatment Procedure for the Digital Component:· In addition to the conventional outpatient program, participants in the experimental group will receive a digital support package comprising: An initial orientation session on application use, symptom reporting, exercise safety, and home monitoring. A smartphone application and/or secure messaging platform for education, reminders, and communication.· A smart phone for step counting and activity monitoring.· Home-based walking or prescribed physical activity on non-clinic days, logged through the digital platform.· Weekly tele coaching or teleconsultation to review progress, symptoms, barriers, and goals.· Automated reminders and motivational messages to support adherence.· Clinician-reviewed adjustment of home activity targets based on symptoms, safety criteria, and monitored activity data.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group A (Study Group): Participants received a 12-week digital health-supported hybrid cardiac rehabExperimental treatment 1 intervention
Group B: Group B (Control Group): Participants received conventional center-based outpatient cardiac rehabiliOther 1 intervention
Trial outcomes
Primary outcomes
1
Six-Minute Walk Test (6MWT):
Functional exercise capacity was evaluated using the 6MWT to determine the total Six-Minute Walk Distance (6MWD) in meters. The assessment adhered to standardized American Thoracic Society (ATS) guidelines, utilizing a 30-meter flat, unobstructed indoor corridor. Standardized encouragement phrases were provided at 1-minute intervals. To eliminate the learning effect, a practice walk was conducted prior to baseline data collection. Continuous heart rate dynamics during the walk were monitored using a synchronized smartwatch (Huawei Watch Fit 3, Huawei Technologies Co., Ltd.). The 6MWD was evaluated at baseline and following the 12-week intervention period
Time frame
12 weeksSecondary outcomes
1
Cardiac Rehabilitation Adherence & Engagement Scale
Adherence will be assessed based on the proportion of prescribed supervised cardiac rehabilitation sessions successfully completed during the 12-week program. For the digital health-supported group, digital engagement will also be assessed through platform utilization, completion of educational modules, and logged home-based activity sessions.
Time frame
throughout the 12-week intervention period.2
Health-Related Quality of Life (HRQoL)
Health-related quality of life will be assessed using the MacNew Heart Disease Health-Related Quality of Life Questionnaire (MacNew), a 27-item cardiac-specific questionnaire evaluating physical, emotional, and social functioning.
Time frame
Baseline (pre-intervention) and at week 12 (post-intervention).3
Psychological Status
Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report questionnaire designed to evaluate psychological distress.
Time frame
Baseline (pre-intervention) and at week 12 (post-intervention).4
Resting Heart Rate (RHR)
Resting heart rate will be assessed as a physiological measure to evaluate cardiovascular response and autonomic balance.
Time frame
Baseline (pre-intervention) and at week 12 (post-intervention).Sponsors and contacts
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Source ClinicalTrials.gov