AzTrials
AzTrials

Myocardial InfarctionCR MI FCNCT07867197

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

A study testing Conventional Treatment group and Digital and Conventional treatment in people with Myocardial Infarction and Tele-rehabilitation, run by Cairo University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 65 years
What is being tested?
Conventional Treatment group and Digital and Conventional treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
6 Jun 2026to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mohamed S Farghaly, B.Sc. in Physical Therapy contact

+20 01006833073 ext. +2001016602066

mohamedshahin938@gmail.com

omar S Farghaly, B.Sc of Medicine and surgery contact

+2001066128801

omarshahin232@gmail.com

Egypt1 site, 1 recruiting
  • Faculty of Physical Therapy, Deraya University

    Minya, Minya Province

    Mohamed S Farghaly, BSc in Physical Therapy, 01006833073, mohamedshahin938@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: EFFECTIVENESS OF A DIGITAL HEALTH-GUIDED CARDIAC REHABILITATION PROGRAM ON FUNCTIONAL CAPACITY, AND QUALITY OF LIFE IN PATIENTS WITH MYOCARDIAL INFARCTION

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:

Read more

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.

Read the detailed description

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.

Being tested
Conventional Treatment group, Digital and Conventional treatment
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Treatment groupProcedure or surgery

    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.

  • Digital and Conventional treatmentProcedure or surgery

    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.

Study groups in NCT07867197
Study groupRoleWhat they receive
Group A (Study Group): Participants received a 12-week digital health-supported hybrid cardiac rehabExperimentalGroup 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.
Receives: Procedure: Digital and Conventional treatment
Group B (Control Group): Participants received conventional center-based outpatient cardiac rehabiliOtherGroup 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
Receives: Procedure: Conventional Treatment group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks

Secondary outcomes (5)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. Blood Pressure (BP)

    Systolic and diastolic blood pressure will be monitored as physiological measures during the cardiac rehabilitation program.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2026
  2. Study start6 Jun 2026
  3. Primary completionOct 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07867197
Sponsor's protocol ID
P.T.REC/012/006640
Acronym
CR MI FC
Status last verified
Oct 2026
First submitted
5 Oct 2026
Last updated
9 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared to maintain participant privacy and strictly adhere to confidentiality agreements.

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Treatment group and Digital and Conventional treatment in people with Myocardial Infarction and Tele-rehabilitation, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohamed S Farghaly, B.Sc. in Physical Therapy (+20 01006833073 ext. +2001016602066, mohamedshahin938@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six-Minute Walk Test (6MWT): (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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