An interventional study of Conventional Treatment group and Digital and Conventional treatment in Myocardial Infarction, Tele-rehabilitation and FUCTIONAL MOBILITY, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 55 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
The Challenge:
Limited Participation in Cardiac Rehabilitation Cardiac rehabilitation is an important part of recovery and secondary prevention for patients with cardiovascular disease. However, participation in conventional center-based cardiac rehabilitation remains limited because of several barriers, including transportation difficulties, cost, work and family commitments, limited referral, and limited availability of rehabilitation programs. These barriers can be particularly challenging for patients living in underserved or low-resource settings, where participation and completion of rehabilitation programs may be poor.
The Goal of the Study :
This study aims to discover if a digital health-supported cardiac rehabilitation program can help improve functional capacity, adherence, quality of life, and psychological status in cardiac patients. Specifically, the research will evaluate the effect of adding digital health support to conventional outpatient cardiac rehabilitation compared with conventional cardiac rehabilitation alone.
How the Study Works? The study will involve 60 medically stable cardiac patients, both men and women, aged 55-65 years, who are eligible for Phase II outpatient cardiac rehabilitation following myocardial infarction and primary percutaneous coronary intervention.
These participants will be randomly divided into two equal groups:
The Digital Health-Supported Group: Participants will receive digital health-supported hybrid cardiac rehabilitation in addition to conventional outpatient cardiac rehabilitation for 12 weeks, with three sessions per week. They will use digital tools to support exercise adherence, activity monitoring, education, reminders, communication, and weekly telecoaching.
The Control Group: Participants will receive conventional outpatient cardiac rehabilitation alone for 12 weeks, with three sessions per week. They will also receive brief weekly phone contact without digital coaching.
Both groups will continue their prescribed medications and usual medical follow-up.
What is Being Measured?
To accurately determine whether the digital health-supported program is effective, the study will evaluate several key areas:
Functional Capacity: The Six-Minute Walk Test (6MWT) will be used as the primary outcome measure to assess functional exercise capacity by measuring the distance participants can walk in six minutes under standardized conditions.
Adherence and Engagement:
The study will assess adherence to the prescribed cardiac rehabilitation sessions. For participants receiving digital support, additional indicators such as platform use, completion of educational modules, and logged home-based activity will also be monitored.
Quality of Life:
Health-related quality of life will be evaluated using the MacNew Heart Disease Health-Related Quality of Life Questionnaire, which assesses physical, emotional, and social functioning.
Psychological Status:
Psychological status will be assessed using the Hospital Anxiety and Depression Scale (HADS) to evaluate symptoms of anxiety and depression.
Physiological Measures:
Resting heart rate and blood pressure will also be assessed as part of the clinical evaluation.
Why This Matters Because participation in conventional cardiac rehabilitation can be affected by geographical, financial, and logistical barriers, finding accessible ways to support patients beyond the rehabilitation center is important. Digital health technologies such as smartphone applications, wearable monitoring, remote communication, and telecoaching may help patients remain engaged with their rehabilitation program.
By comparing digital health-supported cardiac rehabilitation with conventional outpatient cardiac rehabilitation alone, this study hopes to determine whether digital support can provide additional benefits in functional capacity, adherence, quality of life, and psychological status among Phase II cardiac patients.
2,779 studies on the registry are indexed under Myocardial Infarction; 417 are open to participants now.
This study's planned enrollment of 60 is below the median of 148 across 1,613 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Group A (Study Group): Participants received a 12-week digital health-supported hybrid cardiac rehabilitation program in addition to conventional outpatient cardiac rehabilitation, with three rehabilitation sessions per week.
Procedure: Digital and Conventional treatment
Group B (Control Group): Participants received conventional center-based outpatient cardiac rehabilitation for 12 weeks, with three sessions per week. The control group received brief weekly telephone contact without digital coaching
Procedure: Conventional Treatment group
Duration \& 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.
Treatment 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.
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 weeks
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.
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).
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).
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).
Blood Pressure (BP)
Systolic and diastolic blood pressure will be monitored as physiological measures during the cardiac rehabilitation program.
Time frame: (pre-intervention) and at week 12 (post-intervention).
Plan to share: No — Individual participant data will not be shared to maintain participant privacy and strictly adhere to confidentiality agreements.
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