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IRCT20220708055415N1 IRCT 2023-02-25 Shahid Beheshti University of Medical Sciences Investigating The Effect of Aerobic Exercise on Hematopoietic Stem Cells Engraftment in Patients Undergoing Autologous Hematopoietic Cell Transplantation The Effect of Aerobic Exercise on Promoting Hematopoietic Stem Cells Engraftment in Patients Undergoing Autologous Hematopoietic Cell Transplantation 2023-02-20 anticipated 40 Complete https://irct.ir/trial/68293 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: This Study Is a Simple Randomization Type, Individually, Using a Table of Random Numbers, And the Sequence Is Obtained by Referring to Randomization.Com, Blinding description: In this study, Apart From The Patients Themselves And The Main Researcher And The Relevant Treating Doctors, All The Treatment Staff, Including Other Doctors, Nurses, The Person Responsible For Data Collection And Analysis, Are Blind To The Intervention Group. N/A Condition 1: Multiple myeloma. Condition 2: non-Hodgkin lymphoma. Intervention 1: Intervention group: After hospitalization and before transplantation, the patients are first subjected to the mobilization and release of stem cells for about 7 days through the injection of granulocyte colony stimulating factor (GCSF) at the rate of 5-10 (μg/kg per day). In order to implement the sports intervention, informed and written consent is received from the patients. Exercise protocol: First, the patients of the intervention group get to know how to work with the treadmill and the exercise program. On the first day, before starting work on the treadmill and performing the pre-test, the resting heart rate of each patient is recorded by an experienced examiner after at least 5 minutes of rest (sitting or lying down). Because the heart rate response is easily altered by a number of environmental (eg, heat, humidity), dietary (eg, caffeine, after the last meal), and behavioral (eg, anxiety, smoking) factors, patients at least They refrain from smoking or consuming caffeine 30 minutes before the measurement. In each session, before exercising on the treadmill, a 5-minute warm-up with stretching and aerobic exercises is done. Each patient exercises on a treadmill with a zero slope, with an initial intensity of about 40% of the reserve heart rate (HR Reserve) [resting heart rate - maximum heart rate (age - 220) = reserve heart rate], a speed of 0.8 km/h and He starts the 12-minute period that is set, and every day, 5% is added to the training intensity (increasing the training speed by 0.25 km/h) and 3 minutes to the training time, until on the seventh day, approximately The training intensity increases to 60% of the reserve heart rate, the training speed to 2.3 km and the training time to 30 minutes. In the 5 minutes at the end of the training program of each session, the speed gradually decreases and then stops completely. The increase in speed is due to the ability of the patient, who pays full attention to the patient, and the heart rate is continuously monitored during the test, and his condition is monitored and recorded by the examiner (exercise physiologist) at each stage. After performing aerobic exercise on the first day of mobilization and after 7 consecutive days, which is the end of the mobilization period, a blood sample of 5 cc was taken from each patient, immediately after exercise in order to evaluate the number of CD34+ cells, as well as blood samples during hospitalization. And at the time of discharge, in order to measure the amount of white blood cells, hemoglobin and platelets, they are taken from the patients of both groups by a technician and immediately transferred to the transplant laboratory. Intervention 2: Control group: Control group: mobilization and release of stem cells through routine injection of granulocyte colony stimulating factor (GCSF) alone and without exercise intervention. Yes - There is a plan to make this available What will be shared: All the Results of This Study Will Be Published in Several Articles in a Reputable Journals. When: 1401-1402 To whom: All people Conditions: In any situation and for any purpose Where to obtain: Masoomeh Kamyabnia m_kamiyab@yahoo.com How to obtain: As soon as the request is received Comments:
public Masoomeh Kamyabnia
Shahr Qods branch, Islamic Azad University, Kalhor Blvd, Shahr Qods
Tehran Iran (Islamic Republic of) 1471643353 +98 21 4689 6000 m_kamiyab@yahoo.com Islamic Azad University scientific Masoomeh Kamyabnia
No.34(3)-Third Alley ,Mehran Street,Kashani Street,Tehran,Iran
Tehran Iran (Islamic Republic of) 1471643353 +98 21 4401 8556 m_kamiyab@yahoo.com Islamic Azad University Iran (Islamic Republic of) Malignant Disease with Indication of HSCT, Transplantation of Peripheral Blood Stem Cells by Autologous Method, Age between 22 and 62 Years, Performing an Exercise Test Under the Supervision of a Cardiologist to Check the Patient's Cardiovascular Condition. Karnofsky Performance (KPS) with Scores Above 90 Suitable Functional Capacity of the Patient for Walking on the Treadmill. No History of Chronic Diseases such as High Blood Pressure, Severe Heart Failure, Respiratory Disease and Allergies, Diabetes, Kidney Failure, and Orthopedic Problems No History of Treatment and Radiotherapy 22 years 62 years Both Hemoglobin Below Eight Micrograms Per Liter Decrease in Platelets Below 50,000 Symptoms of Fever, Neutropenia, Bleeding, Nausea C90.0 C85 Multiple myeloma Other specified and unspecified types of non-Hodgkin lymphoma Treatment - Other Treatment - Other Intervention group: After hospitalization and before transplantation, the patients are first subjected to the mobilization and release of stem cells for about 7 days through the injection of granulocyte colony stimulating factor (GCSF) at the rate of 5-10 (μg/kg per day). In order to implement the sports intervention, informed and written consent is received from the patients. Exercise protocol: First, the patients of the intervention group get to know how to work with the treadmill and the exercise program. On the first day, before starting work on the treadmill and performing the pre-test, the resting heart rate of each patient is recorded by an experienced examiner after at least 5 minutes of rest (sitting or lying down). Because the heart rate response is easily altered by a number of environmental (eg, heat, humidity), dietary (eg, caffeine, after the last meal), and behavioral (eg, anxiety, smoking) factors, patients at least They refrain from smoking or consuming caffeine 30 minutes before the measurement. In each session, before exercising on the treadmill, a 5-minute warm-up with stretching and aerobic exercises is done. Each patient exercises on a treadmill with a zero slope, with an initial intensity of about 40% of the reserve heart rate (HR Reserve) [resting heart rate - maximum heart rate (age - 220) = reserve heart rate], a speed of 0.8 km/h and He starts the 12-minute period that is set, and every day, 5% is added to the training intensity (increasing the training speed by 0.25 km/h) and 3 minutes to the training time, until on the seventh day, approximately The training intensity increases to 60% of the reserve heart rate, the training speed to 2.3 km and the training time to 30 minutes. In the 5 minutes at the end of the training program of each session, the speed gradually decreases and then stops completely. The increase in speed is due to the ability of the patient, who pays full attention to the patient, and the heart rate is continuously monitored during the test, and his condition is monitored and recorded by the examiner (exercise physiologist) at each stage. After performing aerobic exercise on the first day of mobilization and after 7 consecutive days, which is the end of the mobilization period, a blood sample of 5 cc was taken from each patient, immediately after exercise in order to evaluate the number of CD34+ cells, as well as blood samples during hospitalization. And at the time of discharge, in order to measure the amount of white blood cells, hemoglobin and platelets, they are taken from the patients of both groups by a technician and immediately transferred to the transplant laboratory. Control group: Control group: mobilization and release of stem cells through routine injection of granulocyte colony stimulating factor (GCSF) alone and without exercise intervention. White blood cell count. Timepoint: Before and after transplantation. Method of measurement: Analyzer device, model Hitachi 912 made by Roche, Germany. Hemoglobin count. Timepoint: Before and after transplantation. Method of measurement: Analyzer device, model Hitachi 912 made by Roche, Germany. Platelet count. Timepoint: Before and after transplantation. Method of measurement: Analyzer device, model Hitachi 912 made by Roche, Germany. The number of platelet units injected. Timepoint: After transplantation. Method of measurement: Counting the number of platelet units injected. CD34+ hematopoietic progenitor cells. Timepoint: Before and after transplantation. Method of measurement: flow cytometry (Attune NXT, USA Country). Shahid Beheshti University of Medical Sciences Approved 2023-01-22 Ethics Committee of Shahid Beheshti University of Medical Sciences Bone Marrow Transplant Center ,Taleghani Hospital, Shahid Arabi Stree, Yaman St, Shahid Chamran highway Tehran Tehran Iran (Islamic Republic of)