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IRCT20141127020108N4 IRCT 2022-07-17 Esfahan University of Medical Sciences The effect of an Aerobic and stretching exercise program on Self-Efficacy and mental health The effect of an Aerobic and stretching exercise program on Self-Efficacy and mental health in breast cancer women 2022-08-23 anticipated 64 Complete https://irct.ir/trial/64573 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we will use the block randomization method. Blocking is usually used to balance the number of samples assigned to each of the study groups. The size of all blocks is equal and we will have 4 groups of 4 blocks (including 2 participants in the intervention group and 2 participants in the control group) in this two-group experiment. In this way, we will have 16 blocks of 4 that will divide people into two groups of 32 people. Randomization tool also uses software random allocation software (Random allocation software) that these random sequence generation software in addition to simple randomization are able to generate random sequence by blocking method. Using opaque sealed envelopes, each of the random sequences created is recorded on a card, and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed. N/A Breast Cancer. Intervention 1: Intervention group:According to the sports program developed by a physical education specialist, in this research, sports intervention will be carried out in the intervention group for eight weeks, three sessions per week, each session lasting 35 to 40 minutes. In this study, the exercise protocol will be structured and at home, including three parts: warming up, aerobic exercises and cooling down. On the first day, the prepared package including 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 GB will be provided to the participants.On the day of delivery of equipment and supplies, all sports movements are taught to the patients by the researcher. After the training, in order to ensure the correctness of the learning, the patients are asked to perform each exercise in the presence of the researcher. After providing the necessary training and performing physical exercises, the patients will be added to a WhatsApp group by the researcher. Before the start of the intervention, the questionnaires will be completed in person. After the end of the eighth week in the intervention group, the questionnaires will be completed online through the WhatsApp group. Intervention 2: Control group: The control group received only routine care and completed questionnaires immediately before and after the end of the study. 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 I have not decided yet
public Amir Musa Rezaei
Hazar Jarib Street, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 musarezaie@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Amir Musa Rezaei
Hazar Jarib Street, Isfahan University of Medical Sciences
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) Iran (Islamic Republic of) Patients who are aware of their disease diagnosis. Patients who have the ability to speak and communicate verbally. Patients who are interested in participating in the study. Cancer patients who have been diagnosed for at least one month Patients who have completed at least two chemotherapy sessions. 18 years 65 years Female Patients with mental retardation, blindness, deafness, physical problems and mobility disabilities Patients with any metastases. Patients who are treated with anticoagulant drugs. Patients who have been treated with radiotherapy before chemotherapy. Patients who have a history of any type of cancer other than breast cancer. C50 Malignant neoplasm of breast Other Other Intervention group:According to the sports program developed by a physical education specialist, in this research, sports intervention will be carried out in the intervention group for eight weeks, three sessions per week, each session lasting 35 to 40 minutes. In this study, the exercise protocol will be structured and at home, including three parts: warming up, aerobic exercises and cooling down. On the first day, the prepared package including 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 GB will be provided to the participants.On the day of delivery of equipment and supplies, all sports movements are taught to the patients by the researcher. After the training, in order to ensure the correctness of the learning, the patients are asked to perform each exercise in the presence of the researcher. After providing the necessary training and performing physical exercises, the patients will be added to a WhatsApp group by the researcher. Before the start of the intervention, the questionnaires will be completed in person. After the end of the eighth week in the intervention group, the questionnaires will be completed online through the WhatsApp group. Control group: The control group received only routine care and completed questionnaires immediately before and after the end of the study. The score obtained from the general self-efficacy questionnaire. Timepoint: Immediately before and immediately after the intervention. Method of measurement: Sherer General Self-Efficacy Scale. The score obtained from Depression, anxiety and stress questionnaire DASS-42. Timepoint: Immediately before and immediately after the intervention. Method of measurement: Depression, anxiety and stress questionnaire DASS-42. Esfahan University of Medical Sciences Approved 2022-07-03 Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of Hazar Jarib Street, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)