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IRCT20170111031884N2 IRCT 2019-12-24 Vice Chancellor for research,Tehran Heart Center (TUMS) High Intensity Interval Training in Acute Pulmonary Embolism Effect of 8 weeks High-Intensity Interval Training on Aerobic Capacity, Pulmonary Function, Quality of Life, and Right Ventricular Function in Patients with Acute Pulmonary Embolism: A Randomized Control Trial Study, a Pilot Study 2019-09-01 anticipated 60 Complete https://irct.ir/trial/24971 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using Block stratified Randomization software version 6.0 via permuted block stratified randomization method with random blocks of 4, 8, 2, 6, and 10 patients. Based on this random list, individuals will be dedicated to intermittent exercise or the control group (without exercise). In order to have a random allocation sequence concealment, the list will be given to a research assistant who is unaware of the study protocol and has not a role in the study. Due to the nature of the study, blinding will not be applicable for the patients, outcome assessor and the interventionists and only the statistician is blinded to the study. N/A Acute Pulmonary Embolism. Intervention 1: The intervention group will receive a 8 weeks high intensity interval training, 3 sessions per week. Each session will last 50-55 minutes. Intervention 2: The control group will not receive any intervention. Yes - There is a plan to make this available What will be shared: Study protocol: The entire study protocol is shareable. Statistical Analysis Map: The entire statistical analysis map is shareable. clinical study report: The entire clinical study report is shareable. Data categorization system: The Data categorization system is shareable. When: Start the access period 2 months after printing results To whom: Researchers working in Academic Institutions Conditions: For any kind of research in the field of medicine is possible. Where to obtain: Amine Ghram 00989011631984 ghram.amine@hotmail.fr How to obtain: After sending the request by email within 2 weeks, the documentation is sent by email. Comments:
public Yaser Jenab
Tehran Heart Center, North Kargar Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9600 jenab@razi.tums.ac.ir Tehran Heart Center scientific Yaser Jenab
Tehran Heart Center , North Kargar-Ave , Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9256 jenab@razi.tums.ac.ir Tehran Heart Center Iran (Islamic Republic of) Between 18-70 Years old; admitted with acute pulmonary embolism confirmed by pulmonary CT angiography signed informed consent 18 years 70 years Both History of recurrent pulmonary embolism Low-risk pulmonary embolism Unable to participate in an exercise program Pregnancy Unable to read and understand the consent form I26 Pulmonary embolism Rehabilitation Treatment - Drugs The intervention group will receive a 8 weeks high intensity interval training, 3 sessions per week. Each session will last 50-55 minutes. The control group will not receive any intervention. Aerobic capacity. Timepoint: before and after 8 weeks. Method of measurement: Bruce modified test. Right ventricular function. Timepoint: before and after 8 weeks. Method of measurement: Two-dimensional and Doppler echocardiographic. Pulmonary function. Timepoint: before and after 8 weeks. Method of measurement: Spirometry test. Quality of life. Timepoint: before and after 8 weeks. Method of measurement: SF36 questionnaire. Safety. Timepoint: before, during and after intervnetion. Method of measurement: Assessed by recording the number and type of adverse events and any remedial action recorded in the patient’s exercise diary and interventionist records. Vice Chancellor for research,Tehran Heart Center (TUMS) Approved 2019-07-01 Research Ethics Committee of Sport Sciences Research Institute No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)