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IRCT20231111060023N1 IRCT 2023-11-30 Allameh Tabataba'i University The comparison of cardiac rehabilitation protocols (functional and ordinary) on atherosclerosis biomarkers and functional capacity in coronary arteries patients The comparison of the effect of two cardiac rehabilitation protocols (functional and ordinary) on atherosclerosis biomarkers and functional capacity in coronary arteries patients 2023-10-23 anticipated 30 Complete https://irct.ir/trial/73690 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Coronary artery disease. Intervention 1: Functional group: Functional training group: In the functional training group, moderate functional training (MIFT) will be used, which will include performing functional movements in a circle and using the rule of maximum number and possible rounds (AMRAP) in a period of 30 minutes. The movements will include six major movements, which are: squat, step-up, lunge, high knee jog, rotation with pivot, and Butt-kick jog. During the whole 30 minutes, the heart rate of the subjects will be controlled, and like aerobic training, the intensity of these exercises will be 60% to 80% of the training capacity, using the reserve heart rate, resting heart rate in a stationary or sitting position (HRrest). 20 to 30 beats.min-1} { or the level of perception of pressure 16-12 will be controlled on the scale of 6-20. Intervention 2: Ordinary group: Subjects will train for 8 weeks, 3 sessions a week and each session will last 45 minutes. All sessions include a standard 10-minute warm-up that includes stretching (eg, upper neck mobility, shoulders, thoracic spine, hips, and ankle mobility) and an activity. Cardiovascular and neuromuscular briefs will be without resistance. Next, light static and dynamic stretching will be done. The aerobic training part of each session is rhythmic with large muscle group activities with an emphasis on increasing calorie consumption using a treadmill and bicycle. The duration of aerobic exercise will be 30 minutes and based on ACSM recommendations for people with cardiovascular disease characteristics participating in cardiac rehabilitation. The intensity of these exercises will be 60% to 80% of the training capacity, using the reserve heart rate, resting heart rate in a stationary or sitting position (HRrest)+20 to 30 beats.min-1} { or the pressure perception rate of 12-16 in the 6-20 scale will control. After completing the aerobic training part, the subjects will rest for 2 minutes. Finally, the training session will end with a 5-minute cooling down, including static and dynamic stretching movements, focusing on large joints. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of some patient information and their lack of consent to publish it.
public Rasoul Eslami
Tehran, Olympic Village, Dehkede Square, Central Campus of Allameh University Tabatabai
Tehran Iran (Islamic Republic of) 1489684511 +98 21 4839 0000 eslami.rasul@gmail.com Allameh Tabataba'i University scientific Arezoo Soleymani fard
NO. 66, Arghavan impass, Shahid Hossein Sormeh alley, Tabib Isfahani avenue, Quds square, Isfahan
Isfahan Iran (Islamic Republic of) 81498-67396 +98 31 3447 8046 arezoo_soleymanifard@atu.ac.ir Allameh Tabataba'i University Iran (Islamic Republic of) Coronary artery patients who have surgery, usage of Beta blockers, patients who are over 50 years old, have hypertension, smoking, dyslipidemia, do not have a history of regular exercise, and participate in cardiac rehabilitation programs. 50 years no limit Male Usage of Alcohol. Disabled to do exercise, having a history of regular exercise training. I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Devices Rehabilitation Functional group: Functional training group: In the functional training group, moderate functional training (MIFT) will be used, which will include performing functional movements in a circle and using the rule of maximum number and possible rounds (AMRAP) in a period of 30 minutes. The movements will include six major movements, which are: squat, step-up, lunge, high knee jog, rotation with pivot, and Butt-kick jog. During the whole 30 minutes, the heart rate of the subjects will be controlled, and like aerobic training, the intensity of these exercises will be 60% to 80% of the training capacity, using the reserve heart rate, resting heart rate in a stationary or sitting position (HRrest). 20 to 30 beats.min-1} { or the level of perception of pressure 16-12 will be controlled on the scale of 6-20. Ordinary group: Subjects will train for 8 weeks, 3 sessions a week and each session will last 45 minutes. All sessions include a standard 10-minute warm-up that includes stretching (eg, upper neck mobility, shoulders, thoracic spine, hips, and ankle mobility) and an activity. Cardiovascular and neuromuscular briefs will be without resistance. Next, light static and dynamic stretching will be done. The aerobic training part of each session is rhythmic with large muscle group activities with an emphasis on increasing calorie consumption using a treadmill and bicycle. The duration of aerobic exercise will be 30 minutes and based on ACSM recommendations for people with cardiovascular disease characteristics participating in cardiac rehabilitation. The intensity of these exercises will be 60% to 80% of the training capacity, using the reserve heart rate, resting heart rate in a stationary or sitting position (HRrest)+20 to 30 beats.min-1} { or the pressure perception rate of 12-16 in the 6-20 scale will control. After completing the aerobic training part, the subjects will rest for 2 minutes. Finally, the training session will end with a 5-minute cooling down, including static and dynamic stretching movements, focusing on large joints. Apo-B. Timepoint: 24 hours before the intervention and 72 hours after the intervention. Method of measurement: In order to measure the amount of apoB, 10 cc of blood is taken first. Then 3-4 cc of it will be frozen and then placed in a centrifuge. The samples will be kept at a temperature of 20 degrees and then frozen at a temperature of 70 degrees Celsius. Finally, they will be measured using the biomarker kit from the isolated plasma. MPO. Timepoint: 24 hours before the intervention and 72 hours after the intervention. Method of measurement: In order to measure the amount of MPO, 10 cc of blood is taken first. Then 3-4 cc of it will be frozen and then placed in a centrifuge. The samples will be kept at a temperature of 20 degrees and then frozen at a temperature of 70 degrees Celsius. Finally, they will be measured using the biomarker kit from the isolated plasma. 6MWT. Timepoint: 24 hours before the intervention and 72 hours after the intervention. Method of measurement: It is a simple and inexpensive test, well tolerated by the patient. Also, a walking test for 6 minutes is an alternative to a cardiopulmonary exercise test (CPET) for risk classification in heart failure patients. The walking test should be performed for 6 minutes, preferably inside a closed space, on a flat surface in a corridor with a hard surface, and on a straight path that is usually at least 30 meters long. The patient is told to keep calm, take his medication, and wear comfortable clothes and shoes. The observer records baseline oxygen saturation, heart rate, brachial arterial blood pressure, and Borg scale ratings for dyspnea and fatigue. Now the patient understands the relevant instructions and then prepares to start the test. The walking path must be marked every 3 meters. It is also recommended to place cones at the turns of the paths. During the test, the participants are required to walk at a suitable speed according to their conditions, and they are allowed to do so if they wish to do so. Slow down in the road and stop. Then continue walking as soon as possible. The supervisor should always be ready to provide encouragement to the patient with appropriate phrases such as "You are doing well" and "Keep doing what you are doing". Encouragement has been shown to affect distance traveled, especially in the pediatric population. At the end of the test, the observer again records the Borg scale for shortness of breath and fatigue, and then selectively measures arterial blood pressure, heart rate, and oxygen saturation. The number of laps and additional distance covered by the registration and test is calculated by 6 minutes of walking. TUG. Timepoint: 24 hours before the intervention and 72 hours after the intervention. Method of measurement: The test of getting up and walking is the ability to perform consecutive movement tasks compared to walking and returning. This test is for a distance of 3 meters in a standard way, so that in the first stage, the initial rest is done, then the movement of getting up from the chair, then walking the path to the distance is three meters, turning the track, sitting on a chair and finally taking a final rest. Also, this test has been used to predict the risk of falling at the global level and has been widely accepted as a standard protocol for measuring the basic functional mobility of patients with Parkinson's disease. The normal time to complete this test is 8-12 seconds, which depends on age, and the observations obtained from the get-up-and-go test provide valuable medical information about strength (getting up from a chair), mobility (walking a short distance), and It provides balance (rotation) at the same time in an efficient manner. Gait Speed. Timepoint: 24 hours before the intervention and 72 hours after the intervention. Method of measurement: First, the person walks in a normal state (walking with the aid that is allowed) in a straight line on a flat surface from a starting point to a standing position at a distance of 9 meters. The first distance is 2/ 5 meters. There is no time for 2/5 meters (which is called the acceleration phase). The time taken to move to the next 4-meter track is recorded by a hand-held stopwatch, and then the patient has another 5.2-meter track to be in a stationary position (called the deceleration phase). The fastest two consecutive test phases are recorded. It is described in meters per second. Allameh Tabataba'i University Approved 2023-06-01 Research Ethics Committees of Allameh Tabataba'i University (ATU) 13th floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran St., between South Flamak and Zarafshan, Quds Town (West), Tehran Tehran Tehran Iran (Islamic Republic of)