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IRCT20250603066054N1 IRCT 2025-06-20 Self-funded by the investigators Considering the effect of Two Cardiac Rehabilitation Approaches in Middle-Aged and Elderly Men with Coronary Artery Disease Cardiac Rehabilitation/Secondary Prevention (CRSP) Comparative Effectiveness of Two Cardiac Rehabilitation Approaches in Middle-Aged and Elderly Men with Coronary Artery Disease 2025-07-06 anticipated 32 Complete https://irct.ir/trial/84133 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: This study used a randomized controlled trial design. Thirty-two men with coronary artery disease were randomly assigned to two intervention groups: aerobic training and concurrent (combined) training. Participants were stratified by age (middle-aged and elderly) and then randomly allocated within each stratum using a simple randomization method. Randomization was conducted by an independent researcher using a random number table. Allocation concealment was maintained through coded identifiers, and outcome assessors were blinded to group assignments, Blinding description: Due to the nature of the intervention (supervised exercise training), blinding of participants, care providers, and investigators was not feasible. However, outcome assessors and data analysts were blinded to group allocation to minimize detection and analysis bias. This single-blind approach helped ensure objectivity in data evaluation and result interpretation. 2 Cardiovascular disease including myocardial infarction in men aged 45 to 65. Aerobic Exercise Group:Three weekly sessions of aerobic training including warm-up, main activities (cycling and elliptical at 50–80% max heart rate), and cool-down, with gradual increase over 8 weeks.Aerobic-Resistance Exercise Group:Same aerobic protocol plus two weekly resistance training sessions targeting major muscle groups at 30–50% one-rep max, 12–15 reps.. Yes - There is a plan to make this available What will be shared: Title: Clinical Trial Data on Cardiac Rehabilitation in Middle-Aged and Elderly Men with Coronary Artery Disease Details: This dataset includes de-identified participant data collected during pre- and post-intervention phases of the cardiac rehabilitation study, including demographic information, physiological measurements (blood pressure, heart rate, echocardiography results), and exercise protocol details. When: The data will be available starting 6 months after the publication of the study results. The dataset will remain accessible for a minimum of 5 years through an online data repository. To whom: Available to researchers upon request Conditions: The data will be available for academic and research purposes only. Users must agree to a data use agreement ensuring confidentiality and ethical use. Access to the data will be granted after approval by the principal investigator. Additional note: If the journal requests, the data and related documents will be made available to the journal editors and reviewers upon reasonable request to verify the study findings. Where to obtain: Data and documents will be available from the corresponding author upon reasonable request. How to obtain: Interested researchers should submit a formal request via email to the corresponding author detailing the purpose of data use. The request will be reviewed by the principal investigator for approval. Upon approval, a data use agreement ensuring confidentiality and ethical use must be signed. After completing these steps, access to data/documents will be granted. Comments: No additional comments.
public Heydar.Sadeghi
Faculty of Physical Education and Sport Sciences, Kharazmi University, End of Southern Razan (Shahid Hessari) Street, next to Shahid Keshvari Sports Complex, Mohseni (Mirdamad) Square, Mirdamad Blvd., Tehran, Iran
Tehran Iran (Islamic Republic of) 3311115447 0212228001 h.sadeghi@khu.ac.ir Kharazmi University scientific Heydar Sadeghi
Faculty of Physical Education and Sport Sciences, Kharazmi University, End of Southern Razan (Shahid Hessari) Street, next to Shahid Keshvari Sports Complex, Mohseni (Mirdamad) Square, Mirdamad Blvd., Tehran, Iran
Tehran Iran (Islamic Republic of) 3311115447 +98 21 2222 8001 h.sadeghi@khu.ac.ir Kharazmi University Iran (Islamic Republic of) Middle-aged men (45-65 years) with myocardial infarction Physician’s approval for participation in the exercise program Non-smokers No alcohol consumption 45 years 65 years Male Presence of warning signs during exercise Unstable angina pectoris Dyspnea at rest or severe arrhythmias Chronic diseases causing discomfort during exercise ST segment elevation or depression on ECG during exercise Respiratory disturbances during exercise Inability or unwillingness to complete the exercise program ICD-10: I2 Ischemic heart diseases (I20–I25) Rehabilitation Aerobic Exercise Group:Three weekly sessions of aerobic training including warm-up, main activities (cycling and elliptical at 50–80% max heart rate), and cool-down, with gradual increase over 8 weeks.Aerobic-Resistance Exercise Group:Same aerobic protocol plus two weekly resistance training sessions targeting major muscle groups at 30–50% one-rep max, 12–15 reps. Primary outcomes include changes in systolic and diastolic blood pressure, resting heart rate, left ventricular ejection fraction, and cardiac capacity and performance as assessed by stress testing, measured before and after the 8-week intervention. Timepoint: Primary outcome variables will be measured at two time points: baseline (before the intervention) and immediately after the 8-week exercise program. Method of measurement: Systolic Blood Pressure: Measured using a blood pressure monitor in mmHg.Diastolic Blood Pressure: Measured using a blood pressure monitor in mmHg.Resting Heart Rate: Measured by counting heartbeats per minute at rest.Left Ventricular Systolic Function: Calculated by echocardiography using ejection fraction (stroke volume/end-diastolic volume).Cardiac Capacity and Performance: Assessed using a cardiac stress test (exercise test). Supervisor’s funding Approved 2025-06-01 Kharazmi University Ethics Committee Kharazmi University, Shahid Haghani Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)