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IRCT20171203037737N4 IRCT 2019-05-05 Ahvaz University of Medical Sciences The effect of the combined intervention on physical activity and severity of fatigue in the patients undergoing chemotherapy The effect of the combined intervention of low intensity exercise and slow stroke back massage(SSBM) on physical activity and severity of fatigue in the patients undergoing chemotherapy 2019-02-20 anticipated 46 Complete https://irct.ir/trial/36963 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Health service research, Randomization description: - Subjects participating in research will be placed randomly in control and intervention groups. Assigning intervention to participants was done randomly by randomized permutated blocks with 4 blocks (using randomized permutation table). - Randomization list is prepared by statistics expert. Intervention used in this research is assigned according to randomized list by a person out of study who is not aware of research objectives and will be put in a signed pocket and is given to each participant with regard to corresponding codes. - Determining effect of mixed intervention of low intensity exercise and back massage (in form of surface smashing) on physical activity and exhaustion of patients receiving chemotherapy. N/A Fatigue in patients undergoing chemotherapy. Intervention 1: In the intervention group, back massage is performed three days a week for 4 weeks and each session for 10 minutes. Dorsal massage will be performed in the form of a superficial shock on the back of the patient. Exercise 15 minutes a day as active and isometric movements, stretching and feeding, which will select patients to arrange the movements. The front moves in each member will be 10 seconds and repetitive movements will be 10 times. The mentioned moves will take 10 minutes and the walk will be 5 minutes. The beginning of the week intervention will be zero. At the beginning of the intervention (week zero), at the end of each week, the intensity of fatigue and physical activity will be measured by the tools mentioned. Intervention 2: Control group: Control group received routine program for patients treating with chemotherapy. In control group, amount of exhaustion and physical activity was assessed for 4 weeks in regular intervals (at the same time with intervention group) by mentioned tools. No - There is not a plan to make this available Justification or reason for not sharing IPD is The patient information file will be confidential for ethical reasons
public Marzieh Asadizaker
Golestan
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3373 8331 asadizaker_m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Tina Vosoughi
golestan
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3333 0074 Vosoughi.hto@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Men and women with different types of cancer and undergoing chemotherapy in oncology departments of women and men in Baqaee Hospital 2 in Ahwaz The Lack of musculoskeletal problems and abnormalities which prevent massage or exercise of patient The lack of cardiovascular disease history for doing exercise Not doing any other exercise during study Have at least one chemotherapy course before the study In the base CBC examination (WBC) above 3000, the patient's platelet is above 50,000 and hemoglobin is above 8 In each period, vital signs are within the normal range. Patients living in the city of Ahvaz and the suburbs 18 years 65 years Both The lack of ability to do daily activities Conducting chemotherapy and radiotherapy at the same time Cerebral or skeletal metastasis Rehabilitation Rehabilitation In the intervention group, back massage is performed three days a week for 4 weeks and each session for 10 minutes. Dorsal massage will be performed in the form of a superficial shock on the back of the patient. Exercise 15 minutes a day as active and isometric movements, stretching and feeding, which will select patients to arrange the movements. The front moves in each member will be 10 seconds and repetitive movements will be 10 times. The mentioned moves will take 10 minutes and the walk will be 5 minutes. The beginning of the week intervention will be zero. At the beginning of the intervention (week zero), at the end of each week, the intensity of fatigue and physical activity will be measured by the tools mentioned. Control group: Control group received routine program for patients treating with chemotherapy. In control group, amount of exhaustion and physical activity was assessed for 4 weeks in regular intervals (at the same time with intervention group) by mentioned tools Fatigue severity. Timepoint: The intensity of fatigue of patients will be measured by a questionnaire for 4 weeks and at regular intervals (control group at the same time as the intervention group). Method of measurement: Using the Piper Fatigue Scale and the Standard Physical Activity Scale (IPAQ). Physical activity status. Timepoint: physical activity of patients will be measured by a questionnaire for 4 weeks and at regular intervals (control group at the same time as the intervention group). Method of measurement: Using the Piper Fatigue Scale and the Standard Physical Activity Scale (IPAQ). Ahvaz University of Medical Sciences Approved 2018-11-17 The Ethics Committee of the Jundishapur University of Medical Sciences, Ahwaz Golestan Ahvaz Khouzestan Iran (Islamic Republic of)