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IRCT20141127020108N1 IRCT 2021-12-22 Esfahan University of Medical Sciences Investigating the effect of a combined exercise program on sleep quality and severity of fatigue in breast cancer patients undergoing chemotherapy Investigating the effect of a combined exercise program on sleep quality and severity of fatigue in breast cancer patients undergoing chemotherapy 2021-12-22 anticipated 64 Complete https://irct.ir/trial/60521 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation of samples in the test or control group is done using envelopes that have already been prepared using a random number table. In this way, the researcher first randomly determines that the patients to whom the odd number belongs to the experimental group and those to whom the even number belongs to the control group. He then closes his eyes and places his finger on one of the digits in the random number table. While the direction of movement is predetermined. By moving in the table of random numbers, the researcher selects the required number of samples of even and odd numbers. All numbers will be placed in separate envelopes and all will be placed in a box. When the samples enter the study with the conditions and criteria of easy entry, then the number one card is opened for him and depending on whether this card has an even or odd number, they will be placed in one of the two groups of test or control. Thus, sampling will continue until the specified sample volume is reached. The researcher will consider the loss of samples according to the set exclusion criteria. N/A Breast Cancer. Intervention 1: Intervention group: According to the exercise program compiled by a physical education specialist, in this study, sports intervention in the intervention group will be performed during eight weeks in the form of three sessions per week, each session lasting 35 to 40 minutes. In this study, exercise protocol in a structured way and at home will include three parts: warm-up, aerobic exercise and cooling.On the first day, the prepared package will include the required sports equipment, a CD containing training videos of sports movements, an illustrated training booklet and an internet package with a volume of five gigabytes. On the day of delivery of equipment, all sports movements are taught to patients by the researcher. After the training, in order to ensure the accuracy of learning, patients are asked to perform individual exercises in the presence of the researcher. Intervention 2: Control group: They receive only routine care and complete the questionnaires immediately before the start of the study and eight weeks later. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Amir Musarezaie
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Central Headquarters
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 musarezaie@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Amir Musarezaie
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Central Headquarters
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 musarezaie@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients should be aware of their diagnosis. The patient has the ability to speak and communicate verbally. (Familiar with Persian) Patients do not have mental retardation, blindness, deafness, physical problems and mobility disabilities. Be interested in participating in the study. Patients in the adult age group (18 to 65 years) Cancer patients who have been diagnosed for at least one month Have had at least two sessions of chemotherapy Be treated with one of the AC regimens (adriamycin and cyclophosphamide), the CAF regimen (cyclophosphamide, adriamycin and 5-fluorouracil) or the CEF regimen (cyclophosphamide, epirubicin, 5-fluorouracil). Positioning at a functional level of zero to one based on the performance level criteria of the Eastern Participatory Oncology Group affiliated to the ECOG (WHO) 18 years 65 years Female According to the diagnosis of a psychiatrist in the case, she has an active mental illness and to take drugs related to the active "mental" illness. Have any registered metastases. Treatment with anticoagulants History of any cancer other than breast cancer C50 Malignant neoplasm of breast N/A N/A Intervention group: According to the exercise program compiled by a physical education specialist, in this study, sports intervention in the intervention group will be performed during eight weeks in the form of three sessions per week, each session lasting 35 to 40 minutes. In this study, exercise protocol in a structured way and at home will include three parts: warm-up, aerobic exercise and cooling.On the first day, the prepared package will include the required sports equipment, a CD containing training videos of sports movements, an illustrated training booklet and an internet package with a volume of five gigabytes. On the day of delivery of equipment, all sports movements are taught to patients by the researcher. After the training, in order to ensure the accuracy of learning, patients are asked to perform individual exercises in the presence of the researcher Control group: They receive only routine care and complete the questionnaires immediately before the start of the study and eight weeks later. Score from the sleep quality questionnaire. Timepoint: Immediately before the intervention and after the end of the eighth week. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Score from the fatigue severity questionnaire. Timepoint: Immediately before the intervention and after the end of the eighth week. Method of measurement: Piper Fatigue Scale (PFS). Esfahan University of Medical Sciences Approved 2020-11-18 Research Ethics Committees of Vice-Chancellor in Research Affairs -Medical University of Isfahan Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Central Headquarters Isfahan Isfehan Iran (Islamic Republic of)