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IRCT20230828059290N1 IRCT 2023-09-04 Khoram-Abad University of Medical Sciences The effect of exercise and Ganoderma mushroom on breast cancer The effect of 8 weeks of intermittent exercise and Ganoderma mushroom consumption on the structure and function of the heart of women undergoing chemotherapy with breast cancer 2023-09-23 anticipated 60 Complete https://irct.ir/trial/72324 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: In this method, block randomization will be used. In order to perform block randomization, a specific code will be assigned to each of the people under study (60 people). Then, blocks with a volume of 8 people, which have 4 exclusive codes, are defined. Two A codes, two B codes, two C codes, and two D codes are defined. Each of these four codes represent each of the groups under study. From the combination and sequence of these codes in blocks of 8, different blocks are created. Then, using Stata software version 17 and using the command code egen block, blocks of 8 are selected by a simple random method with placement. Using a simple random method with placement, the number of 8 blocks is selected and considering that the sample size is equal to 60 people, half of the eighth block will be included in the study. N/A breast cancer. Intervention 1: Intervention group:Ganoderma mushroom consumption group will consume 1.6 grams of Ganoderma mushroom powder in capsule form daily for 8 weeks. Ganoderma capsules are prepared by the Faculty of Pharmacy of Lorestan University of Medical Sciences. In order to coordinate and check the effect of Ganoderma mushroom, Ganoderma capsules will be taken every day at 6 pm. Intervention 2: Intervention group: Interval training:Intervention group: Intermittent training group: The subjects of the training group will perform three sessions of incremental aerobic exercise every week for eight weeks, the intensity of which will be determined according to the target heart rate. The target heart rate was calculated based on the Karonen method. The subjects will perform three training sessions a week under the supervision of two permanent experts. Based on the research and considering the age of the subjects, low to moderate intensity exercise will be used for these patients. Heart rate was measured using a polar heart rate monitor. The subjects of the exercise group will participate in the program for eight weeks and three sessions each week, each session lasting 60 minutes. The training protocol of the high-intensity interval group also included 4 intervals of 4 minutes with an intensity of 50-75% of the maximum heart rate and 3 minutes of active rest with an intensity of 50% of the maximum heart rate. The subjects of this group will start the exercise with the intensity of 60% of the maximum heart rate and gradually with the progress of the subjects' preparation, the intensity of the exercise will be increased by 5% every week. Intervention 3: Intervention group: Intermittent training group + consumption of Ganoderma mushroom. This group will perform interval training three times a week for eight weeks and consume 1.6 grams of Ganoderma mushroom powder in capsule form daily for 8 weeks. Intervention 4: Control group: Do not have any sports activities and Ganoderma mushroom consumption. Yes - There is a plan to make this available What will be shared: Participants' data is confidential When: The data will be provided to the participants after analysis To whom: Research team Conditions: To publish as an article Where to obtain: To the laboratory and the executive of the research project How to obtain: There is no special process Comments:
public Fazlollah Fathollahi shoorabeh
Anoushirvan Square
Khorramabad Iran (Islamic Republic of) 7412589632 +98 66 3312 0175 f.fathollahi1363@gmail.com Khoram-Abad University of Medical Sciences scientific Fazlollah Fathollahi Shoorabeh
Anoushirvan square
Khorramabad Iran (Islamic Republic of) 9512478632 +98 916 077 9310 f.fathollahi1363@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) No radiotherapy Chemotherapy No surgery Not having any heart disease Not consuming cigarettes and alcoholic beverages, not having physical problems such as orthopedic and brain-neural problems that prevent exercise, blood pressure > 110/180 as a criterion for exiting the study process, not having continuous exercise before starting the training program, not having metastases. Age range from 35 to 55 35 years 55 years Female Reluctance to participate in the plan Having heart disease C50.0 Malignant neoplasm of nipple and areola Prevention Prevention Prevention Diagnosis Intervention group:Ganoderma mushroom consumption group will consume 1.6 grams of Ganoderma mushroom powder in capsule form daily for 8 weeks. Ganoderma capsules are prepared by the Faculty of Pharmacy of Lorestan University of Medical Sciences. In order to coordinate and check the effect of Ganoderma mushroom, Ganoderma capsules will be taken every day at 6 pm. Intervention group: Interval training:Intervention group: Intermittent training group: The subjects of the training group will perform three sessions of incremental aerobic exercise every week for eight weeks, the intensity of which will be determined according to the target heart rate. The target heart rate was calculated based on the Karonen method. The subjects will perform three training sessions a week under the supervision of two permanent experts. Based on the research and considering the age of the subjects, low to moderate intensity exercise will be used for these patients. Heart rate was measured using a polar heart rate monitor. The subjects of the exercise group will participate in the program for eight weeks and three sessions each week, each session lasting 60 minutes. The training protocol of the high-intensity interval group also included 4 intervals of 4 minutes with an intensity of 50-75% of the maximum heart rate and 3 minutes of active rest with an intensity of 50% of the maximum heart rate. The subjects of this group will start the exercise with the intensity of 60% of the maximum heart rate and gradually with the progress of the subjects' preparation, the intensity of the exercise will be increased by 5% every week. Intervention group: Intermittent training group + consumption of Ganoderma mushroom. This group will perform interval training three times a week for eight weeks and consume 1.6 grams of Ganoderma mushroom powder in capsule form daily for 8 weeks. Control group: Do not have any sports activities and Ganoderma mushroom consumption The size of the left ventricular cavity at the end of diastole. Timepoint: 48 hours before and after the last training session. Method of measurement: Eco cardiography. The size of the left ventricular cavity at the end of systole. Timepoint: 48 hours before and after the last training session. Method of measurement: Eco cardiography. The size of the interventricular septum in the diastole phase. Timepoint: 48 hours before and after the last training session. Method of measurement: Eco cardiography. The size of the thickness of the dorsal free wall of the left ventricle. Timepoint: 48 hours before and after the last training session. Method of measurement: Eco cardiography. Left ventricular mass size. Timepoint: 48 hours before and after the last training session. Method of measurement: Eco cardiography. Maximum oxygen consumption (VO2peak). Timepoint: 48 before and after the last training session. Method of measurement: Rockport walking test. Blood pressure. Timepoint: 48 before and after the last training session. Method of measurement: Sphygmomanometer. Khoram-Abad University of Medical Sciences Approved 2023-08-09 Lorestan University of Medical Sciences Research Ethics Committees Certificate st khoramabad Lorestan Iran (Islamic Republic of)