Effectiveness of Digital Cardiac Rehabilitation on Functional Capacity in Patients With Myocardial Infarction

NCT07867197 | Recruiting

• 1 other identifier: P.T.REC/012/006640
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Infarction; Tele-rehabilitation; FUCTIONAL MOBILITY

Outcome Measures

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

  12 weeks

Secondary Outcomes (5)

• Cardiac Rehabilitation Adherence & Engagement Scale

  throughout the 12-week intervention period.

• Health-Related Quality of Life (HRQoL)

  Baseline (pre-intervention) and at week 12 (post-intervention).

• Psychological Status

  Baseline (pre-intervention) and at week 12 (post-intervention).

• Resting Heart Rate (RHR)

  Baseline (pre-intervention) and at week 12 (post-intervention).

• Blood Pressure (BP)

  (pre-intervention) and at week 12 (post-intervention).

Study Arms (2)

Group A (Study Group): Participants received a 12-week digital health-supported hybrid cardiac rehab

EXPERIMENTAL

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 rehabili

OTHER

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

Interventions

Conventional Treatment group PROCEDURE

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.

Group B (Control Group): Participants received conventional center-based outpatient cardiac rehabili

Digital and Conventional treatment PROCEDURE

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.

Group A (Study Group): Participants received a 12-week digital health-supported hybrid cardiac rehab

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Ability to walk independently, with or without an assistive device.
• Ownership of a smartphone with stable internet access, or availability of a caregiver who can assist with smartphone use.
• Willingness to follow the study procedures and provide written informed consent.

You may not qualify if:

• 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.
• Severe cognitive impairment or communication difficulties that prevent adequate cooperation.
• Severe visual or hearing impairment that prevents safe use of the required digital technologies.
• Inability or unwillingness to use the digital rehabilitation platform, even with caregiver assistance.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Deraya University

Minya, Minya Province, Egypt

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• MARWA M ELSAYED, Assistant Professor

  Cairo University

  STUDY CHAIR

• SANDRA A GUIRGUIS, Lecturer

  Cairo University

  STUDY DIRECTOR

• MIOHAMED G ABDEL NABY FARAG, Lecturer

  Minia University

  STUDY DIRECTOR

Central Study Contacts

Mohamed S Farghaly, B.Sc. in Physical Therapy

CONTACT

+20 01006833073; mohamedshahin938@gmail.com

omar S Farghaly, B.Sc of Medicine and surgery

CONTACT

+2001066128801; omarshahin232@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: June 6, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)