Evaluation and comparison of the effectiveness of a 12-session center-based cardiac rehabilitation course with a hybrid form of cardiac rehabilitation course on changes in myocardial function indices, risk factors and quality of life in patients with ischemic heart disease

Assessment and comparison of changes in myocardial functional indices, risk factors, and quality of life in patients with ischemic heart disease after 12-session cardiac rehabilitation in two groups: center-based group and hybrid group (combination of center-based and home-based)

Clinical trial with two parallel groups (center-based and hybrid) with 63 participants in each group, single-blinded and randomized using random numbers table.

Study Location: Isfahan Cardiovascular Rehabilitation Center; study population: patients with ischemic heart disease; type of blinding: single-blind (researcher and analyzer); blinding method: Patients will be assigned to two groups, intervention, and control, by the clinical observer. However, the clinical observer will provide the collected data to the researcher and analyzer after anonymizing the intervention and control groups.

Inclusion criteria: the patient has been treated for ischemic heart disease; at least two weeks have passed since undergoing PCI (percutaneous coronary intervention) or four weeks have passed since CABG (coronary artery bypass grafting); being at the age of 30-80 years old. Non-inclusion criteria: contraindications for cardiac rehabilitation; physician's non-consent for patient's participation in the study; patient who do not consent to participate in the study.

Intervention group: hybrid; In this group, cardiac rehabilitation is conducted with 6 in-person sessions at the cardiac rehabilitation center and 6 virtual sessions at the individual's home. Control group: center-based; In this group, cardiac rehabilitation is conducted in person at the cardiac rehabilitation center over 12 sessions.

Average functional capacity (METs) of patient based on exercise test.

Randomization will be conducted through tables of random numbers and by computers that generate numbers randomly. The table of random numbers to be used is produced by the RAND Corporation (www.rand.org). These tables have random numbers in both row and column directions. First, all patients' names will be numbered. Then, the researcher selects a random number from the table of random numbers for selecting individuals in the intervention group. After selecting one number randomly, the researcher moves either in the row or column direction and sequentially chooses the next individuals until the last person in the intervention group is determined. The remaining individuals will be assigned to the control group.

Patients are randomly assigned to two groups, hybrid and center-based, and the clinical observer records the relevant information after conducting the intervention. Then, without specifying the name of each group (as A and B), this information is provided to the researcher and analyzer in a file. The analyzer and researcher remain unaware of which group the data corresponds to.

After completing the study, the results comparing the intervention and control groups for each variable are published in an article and made available to the public. The individual participants' data files will be made available to researchers through a virtual server in a secure research environment (SRE). Researchers can access the raw data files in this environment after anonymizing the individuals and performing their analysis on them.

The results of the study are accessible after the article is published. Access to the individual participants' data file will be possible for researchers 6 months after the publication of the article.

The results of the study will be made available to the public in the form of an article. The raw data file will only be provided to researchers from reputable academic and scientific institutions.

These data will be made available to researchers for relevant studies or to complement previous research. Adherence to research ethics principles and the preservation of intellectual property rights are necessary for accessing the information. Researchers can access and observe the raw data of the participants in a secure research environment (SRE) after anonymizing them, and they can perform statistical analysis on the data or generate reports based on it.

To access the data, researchers can contact the Cardiovascular Research Institute of Isfahan University of Medical Sciences. Email: crc@mui.ac.ir Phone number: 00983136115310 Address: Isfahan Cardiovascular Research Institute, Rahmani Alley, next to Chamran Cardiac Educational and Treatment Center, Moshtagh 3rd Street, Isfahan. Website: icri.mui.ac.ir

1. Submitting a request by the researcher to the Research Deputy of the Cardiovascular Research Institute. 2. Approval of the request and signing a memorandum of understanding. 3. Setting up the SRE environment for the researcher. 4. Uploading the data and dictionary for observation and analysis. 5. Sending the final report and output to the researcher after the approval of the Research Deputy.