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IRCT20230705058678N1 IRCT 2023-08-27 Isfahan Cardiovascular Research Institute Comparison of hybrid and center-based cardiac rehabilitation 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 2023-08-23 anticipated 126 Complete https://irct.ir/trial/71106 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. N/A Cardiac rehabilitation. Intervention 1: Intervention group: In this group, cardiac rehabilitation will be conducted through 6 sessions at the center and another 6 sessions at home. Each cardiac rehabilitation exercise session at the center will last for 60 minutes and will include stretching and low-intensity exercises for warming up, lasting 5 to 10 minutes. Then, the main exercise regimen for the patient will be performed using exercise equipment such as ergometers and treadmills, followed by 5 to 10 minutes of cool-down exercises for recovery. During the 6-session rehabilitation course conducted at home, participants will receive educational instructions on healthy nutrition, risk factor control, as well as engage in physical activities provided through instructional CDs. Participants' walking will be recorded using a pedometer, and their daily physical activity duration, intensity, and distance covered will be noted and evaluated using a daily physical activity log table. Intervention 2: Control group: In this group, 12 sessions of rehabilitation will be conducted at the center. Each cardiac rehabilitation exercise session at the center will last for 60 minutes and will include stretching and low-intensity exercises for warming up, lasting 5 to 10 minutes. Then, the main exercise regimen for the patient will be performed using exercise equipment such as ergometers and treadmills, followed by 5 to 10 minutes of cool-down exercises for recovery. Yes - There is a plan to make this available What will be shared: 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. When: 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. To whom: 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. Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Sina Rouhani
Cardiac Rehabilitation Research Center, Isfahan Cardiovascular Research Institute, Shahid Rahmani Alley, next to Shahid Chamran Hospital, Mushtaq 3rd St.
Isfahan Iran (Islamic Republic of) 8158388994 +98 31 3611 5208 sn.rouhani@gmail.com Esfahan University of Medical Sciences scientific Masoumeh Sadeghi
Cardiac Rehabilitation Research Center, Isfahan Cardiovascular Research Institute, Shahid Rahmani Alley, next to Shahid Chamran hospital, Mushtaq 3rd St.
Isfahan Iran (Islamic Republic of) 8158388994 +98 31 3611 5208 sadeghimasoumeh@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) The patient has been treated for ischemic heart disease in one of the hospitals in Isfahan City At least two weeks have passed since PCI or 4 weeks since CABG The minimum age for participation in the study is 30 years, and the maximum age is 80 years 30 years 80 years Both Contraindications for cardiac rehabilitation Patients who do not consent to participate in the study Physician's non-consent for patient's participation in the study. I20.9 Angina pectoris, unspecified Rehabilitation Rehabilitation Intervention group: In this group, cardiac rehabilitation will be conducted through 6 sessions at the center and another 6 sessions at home. Each cardiac rehabilitation exercise session at the center will last for 60 minutes and will include stretching and low-intensity exercises for warming up, lasting 5 to 10 minutes. Then, the main exercise regimen for the patient will be performed using exercise equipment such as ergometers and treadmills, followed by 5 to 10 minutes of cool-down exercises for recovery. During the 6-session rehabilitation course conducted at home, participants will receive educational instructions on healthy nutrition, risk factor control, as well as engage in physical activities provided through instructional CDs. Participants' walking will be recorded using a pedometer, and their daily physical activity duration, intensity, and distance covered will be noted and evaluated using a daily physical activity log table. Control group: In this group, 12 sessions of rehabilitation will be conducted at the center. Each cardiac rehabilitation exercise session at the center will last for 60 minutes and will include stretching and low-intensity exercises for warming up, lasting 5 to 10 minutes. Then, the main exercise regimen for the patient will be performed using exercise equipment such as ergometers and treadmills, followed by 5 to 10 minutes of cool-down exercises for recovery. Average functional capacity (METs) of patients based on exercise test. Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: Exercise test. Quality of life score based on MacNew questionnaire. Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: MacNew questionnaire. Anxiety score in Spielberger questionnaire. Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: Spielberger questionnaire. Depression score in Beck questionnaire. Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: Beck questionnaire. The amount of physical activity based on the IPAQ questionnaire. Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: IPAQ questionnaire. Smoking. Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: Questionnaire. Serum level of Triglyceride. Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: Testing the patient blood sample. The changes in systolic blood pressure. Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: Sphygmomanometer. The changes in body mass index (BMI). Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: Body mass index formula. Fasting blood sugar level. Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: Testing the patient blood sample. The changes in diastolic blood pressure. Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: Sphygmomanometer. Serum level of cholesterol. Timepoint: At the beginning of the study (prior to intervention) and at the end of the study after 12 rehabilitation sessions. Method of measurement: Testing the patient blood sample. Isfahan Cardiovascular Research Institute Approved 2021-04-05 Biomedical Ethics Research Committee of School of Medicine - Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar jarib ave. Isfahan Isfehan Iran (Islamic Republic of)