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IRCT20200228046637N1 IRCT 2020-04-03 Mazandaran University of Medical Sciences The effect of motor exercises on quality of life, depression and anxiety in women with breast cancer The effect of motor exercises on quality of life, depression and anxiety in women with breast cancer 2019-10-07 anticipated 70 Complete https://irct.ir/trial/46212 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Subjects are numbered on entry to the treatment center and will be assigned to one of the intervention or control groups using random numbers table and simple randomization method. N/A breast cancer. Intervention 1: Intervention group: Depression, quality of life and demographic questionnaires will be completed as a pre-test. The written consent of the research firm is obtained from them. Motion training is provided by a research associate (sports medicine specialist).Then a 6-minute walk test is performed for the patients to assess their fitness level and to measure shoulder joint range of motion with goniometer. The exercises that are used are selected in consultation with a specialist in sports medicine and patients. The intervention will then be administered to the patients for a 5-week regular walk and arm movements with pamphlets.Arm exercises begin on the second day after surgery and are performed 3 times a week for 20 minutes each time for 5 weeks. If the patient feels uncomfortable, taking a warm shower before exercise can also reduce joint stiffness and ease. Subjects are told that there is no compulsion to continue activities during the sessions and that they can be discouraged if they experience slight fatigue and unpleasant feelings. After the training, the post-test will also be repeated to assess the difference between the groups and the impact of the interventions. Intervention 2: Control group: First, the goals of the research will be explained to them, and then as a pre-test, they will complete the Depression, Quality of Life and Demographic Questionnaires. Based on the results of the questionnaires and according to the inclusion and exclusion criteria of the eligible people, they are randomly assigned to the control group. They are asked not to participate in any organized exercise program during this time. After 5 weeks, they will be tested again to assess the difference between the groups. At the end of the intervention, participants will be instructed on the ethical considerations of walking and arm movements. And a pamphlet is given to them. Yes - There is a plan to make this available What will be shared: Primary and secondary outcome information is shared anonymously. When: Access started 6 months after the results were published. To whom: Accessible to all researchers working in academic institutions and specialists in breast surgery Conditions: The results of documentation and data can be used for or not to be used on breast surgery patients. Where to obtain: The person responsible for the public accountability of the study can provide information to eligible individuals. Fahimeh Qasemi Cherati, fahime.ghasemi24@gmail.com How to obtain: If the person is eligible to request access to the documentation, it will be attempted to provide it as soon as possible after it has been demonstrated that the person is authorized to access the data. Comments: I hope that the results of the research will help improve the condition of patients.
public Fahimeh Ghasemi Cherati
Sari-Shahband Street-Vesal square-Nasibeh School of Nursing and Midwifery
Sari Iran (Islamic Republic of) 4816715793 +98 11 3379 5555 fahime.ghasemi24@gmail.com Mazandaran University of Medical Sciences scientific Vida Shafipour
Sari-Shahband Street-Vesal square-Nasibeh School of Nursing and Midwifery
Sari Iran (Islamic Republic of) 4816715793 +98 11 3379 5555 shafivida@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) women with breast cancer Non-metastatic non-postmenopausal over 18 years of age at least literate one or both breast drains The drain has been removed no psychological treatment experience no drug addiction No heart disease No respiratory disease no history of regular physical activity one year prior to the study patient consent to participate in research and written consent 18 years no limit Female Subject's unwillingness to continue the intervention physical disability of the intervention due to treatment periods Unable to walk Unable to stand People with a HADS questionnaire score of less than 11. C50 Malignant neoplasm of breast Rehabilitation Other Intervention group: Depression, quality of life and demographic questionnaires will be completed as a pre-test. The written consent of the research firm is obtained from them. Motion training is provided by a research associate (sports medicine specialist).Then a 6-minute walk test is performed for the patients to assess their fitness level and to measure shoulder joint range of motion with goniometer. The exercises that are used are selected in consultation with a specialist in sports medicine and patients. The intervention will then be administered to the patients for a 5-week regular walk and arm movements with pamphlets.Arm exercises begin on the second day after surgery and are performed 3 times a week for 20 minutes each time for 5 weeks. If the patient feels uncomfortable, taking a warm shower before exercise can also reduce joint stiffness and ease. Subjects are told that there is no compulsion to continue activities during the sessions and that they can be discouraged if they experience slight fatigue and unpleasant feelings. After the training, the post-test will also be repeated to assess the difference between the groups and the impact of the interventions. Control group: First, the goals of the research will be explained to them, and then as a pre-test, they will complete the Depression, Quality of Life and Demographic Questionnaires. Based on the results of the questionnaires and according to the inclusion and exclusion criteria of the eligible people, they are randomly assigned to the control group. They are asked not to participate in any organized exercise program during this time. After 5 weeks, they will be tested again to assess the difference between the groups. At the end of the intervention, participants will be instructed on the ethical considerations of walking and arm movements. And a pamphlet is given to them. Quality of Life. Timepoint: Before intervention - 5 weeks later. Method of measurement: 1) QLQ-C30 specific quality of life questionnaire and 2 quality of life questionnaire for breast cancer patients: EORTC QLQ-C23.V.3. Depression and anxiety. Timepoint: Before intervention - 5 weeks later. Method of measurement: HADS Hospital Expression and Anxiety Questionnaire. Level of physical fitness. Timepoint: Before surgery, after drainage, 5 weeks later. Method of measurement: 6 minute walk test. Joint angles and axis view of joint motion. Timepoint: Goniometer. Method of measurement: Before surgery, after drainage, 5 weeks later. Mazandaran University of Medical Sciences Approved 2018-12-19 Imam Educational Hospital of Sari-Mazandaran University of Medical Sciences Sari-Shahband Street-Vesal square-Nasibeh School of Nursing and Midwifery Sari Mazandaran Iran (Islamic Republic of)