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IRCT20210827052304N2 IRCT 2022-12-03 Tehran University of Medical Sciences Effect of cardiac rehabilitation on inflammatory markers Effects of cardiac rehabilitation on C-reactive protein, neutrophil-to-lymphocyte, and platelet-to-lymphocyte ratio in unstable ischemic heart disease patients following percutaneous coronary intervention: A randomized clinical trial 2018-01-01 anticipated 120 Complete https://irct.ir/trial/61126 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients were allocated in the two groups by permuted stratified randomization technique ( ratio 2:1 , for each control patient we enrolled 2 cases in the intervention group) with random block sizes of 3,6,12,6, and 18. Unit of randomization was individuals. The computer software ( Block stratified randomization windows version 6 copyright 2010 by Steven Patntadosi) was used for randomization. Given the single-centre nature of the study, an intra-hospital web-based registry software was designed by the IT specialists of the hospital and the generated random sequence were recorded in it ,therefore allocation concealment (random sequence concealment) was carried out. N/A Evaluating inflammatory markers in patients with unstable ischemic heart diseases after cardiac rehabilitation. Intervention 1: Intervention group: , Patients in the intervention group underwent a 12-week cardiac rehabilitation. The cardiac rehabilitation program included once-a-week supervised aerobic exercise session and once-a-week educational sessions for 12 weeks which started immediately after discharge. In the former, patients warmed up for 10 minutes, did isometric movements for 30 minutes, and then coolled down for 10 minutes. Patients' exercise intensity gradually increased from 50 to 80% of the heart rate reserve. In the latter, patients were educated about various lifestyle modifications: routine checking of vital signs, losing extra weight, quitting smoking, consuming appropriate fresh fruit, vegetables, fibers, and cereals, reducing alcohol, salt, and fat intake, and avoiding extreme heat and cold preventing heavy activities. In addition, patients learnent how to identify and tackle everyday sources of stress. They also received the routine care after PCI including including dual platelet inhibition, acetylsalicylic acid (Pars Darou company), and clopidogrel (Abidi company) in addition to statins (Sobhan Darou company), in accordance with current guidelines. Intervention 2: Control group: Patients in this group only received the routine care after PCI including dual platelet inhibition, acetylsalicylic acid, and clopidogrel in addition to statins, in accordance with current guidelines. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mana Jameie
Tehran heart center, North-Kargar Ave
Tehran Iran (Islamic Republic of) 1411713138 009888029600 jameie.mana@gmail.com Tehran University of Medical Sciences scientific Pejman Mansouri
Tehran Heart center, North-Kargar ave
Tehran Iran (Islamic Republic of) 1411713138 09982188029600 dr.pmansouri@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) All > 18 years patients with unstable ischemic heart disease (UIHD) with negative enzymes who had undergone successful percutaneous coronary intervention (PCI) Informed consent 18 years 70 years Both Age > 70 years History of dysrhythmia History of decompensated heart failure History of coronary artery bypass graft (CABG) History of myocardial infarction Uncontrolled hypertension Uncontrolled diabetes mellitus, Physical disability History of respiratory dysfunction History of cerebrovascular diseases History of severe valvular heart diseases History of any known inflammatory diseases other than atherosclerosis Ongoing clinical infection Planned surgery within the next four months I20.0 Unstable angina Rehabilitation N/A Intervention group: , Patients in the intervention group underwent a 12-week cardiac rehabilitation. The cardiac rehabilitation program included once-a-week supervised aerobic exercise session and once-a-week educational sessions for 12 weeks which started immediately after discharge. In the former, patients warmed up for 10 minutes, did isometric movements for 30 minutes, and then coolled down for 10 minutes. Patients' exercise intensity gradually increased from 50 to 80% of the heart rate reserve. In the latter, patients were educated about various lifestyle modifications: routine checking of vital signs, losing extra weight, quitting smoking, consuming appropriate fresh fruit, vegetables, fibers, and cereals, reducing alcohol, salt, and fat intake, and avoiding extreme heat and cold preventing heavy activities. In addition, patients learnent how to identify and tackle everyday sources of stress. They also received the routine care after PCI including including dual platelet inhibition, acetylsalicylic acid (Pars Darou company), and clopidogrel (Abidi company) in addition to statins (Sobhan Darou company), in accordance with current guidelines Control group: Patients in this group only received the routine care after PCI including dual platelet inhibition, acetylsalicylic acid, and clopidogrel in addition to statins, in accordance with current guidelines High sensitivity CRP. Timepoint: The mentioned factor were taken at Baseline mode (ie before the discharge of patients admitted for PCI). After this time, patients in the intervention group received 12 week cardiac rehabilitation and the control group received only routine care. At the end of 12 weeks, blood samples were taken again from both groups of patients. Method of measurement: hs-CRP : hs-CRP kit by ROCHE company. Platelet to lymphocyte ratio. Timepoint: The mentioned factor were taken at Baseline mode (ie before the discharge of patients admitted for PCI). After this time, patients in the intervention group received 12 week cardiac rehabilitations and the control group received only routine care. At the end of 12 weeks, blood samples were taken again from both groups of patients. Method of measurement: PLR : platelet count( per cubic millimeter of blood) divided by lymphocyte count ( per cubic millimeter of blood) . Cell count was performed using SYSMEX cell counter. Neutrophil to lymphocyte ratio. Timepoint: The mentioned factor were taken at Baseline mode (ie before the discharge of patients admitted for PCI). After this time, patients in the intervention group received 12 week cardiac rehabilitations and the control group received only routine care. At the end of 12 weeks, blood samples were taken again from both groups of patients. Method of measurement: NLR : neutrophil count( per cubic millimeter of blood) divided by lymphocyte count ( per cubic millimeter of blood) - Cell count was performed using SYSMEX cell counter. Tehran University of Medical Sciences Approved 2019-12-21 Research Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences Office of Vice-Chancellor for Global Strategies and International Affairs, Number 21, Dameshgh St., Vali-e Asr Ave., Tehran 1416753955 Iran Tehran Tehran Iran (Islamic Republic of)