Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
