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IRCT20230919059471N1 IRCT 2023-10-28 Islamic Azad University The impact of exercise on breast cancer quality of life The impact of an exercise program on coping self-efficacy and quality of life in breast cancer patients. 2023-11-06 anticipated 30 Complete https://irct.ir/trial/73318 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, an exercise program includes a 12-week supervised exercise program set by an exercise physiologist. This program will include aerobic exercises, resistance exercises, balance exercises and flexibility exercises in a combined manner and in a regular sequence, taking into account the guidelines of the American College of Sports Medicine (ACSM). The implementation of the exercise program is carried out by an exercise coach who knows the details of exercise in breast cancer. Timing, duration of exercise, intensity of exercise and type of combined exercises are determined separately, Randomization description: Eligible patients are selected using available sampling method and are placed in two exercise and control groups based on simple randomization. Participants are randomized by random assignment through a coin toss into two exercise and usual care groups. The face of the coin (i.e. lion = control group), and the back of the coin (i.e. line = intervention group) are considered, Blinding description: In this study, the medical personnel (doctors, nurses, physiotherapists, etc.) who are responsible for the care of the patients, and those who analyze the data and evaluate the outcome, and those who prepare the draft of the article; They are blinded to study group allocation. N/A Breast Cancer. Intervention 1: Intervention group: intervention group: exercise group; They receive an exercise program including 12-week supervised exercises developed by a sports physiologist, 3 days a week for 50-60 minutes. This program will include aerobic exercises, resistance exercises, flexibility exercises and balance exercises. Aerobic exercise class consists of three parts: warm-up, aerobic exercises, and cool-down. Intervention 2: Control group: Patients in the control group only do their normal physical activities and are provided with educational brochures about routine care. Yes - There is a plan to make this available What will be shared: Part of the data, such as the information related to the main outcome or the like, can be shared. When: The access period starts 6 months after the results are published. To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: Researchers working in academic and scientific institutions at the rank of assistant professor and higher. Where to obtain: Islamic Azad University, Najafabad branch How to obtain: Apply by email Comments:
public Faridokht Yazdani
Islamic Azad University, Najaf Abad Branch, University Blvd
Najafabad Iran (Islamic Republic of) 8514143131 +98 31 4229 2583 faridokht.yazdani@yahoo.com Islamic Azad University scientific Faridokht Yazdani
Islamic Azad University, Najaf Abad Branch, University Blvd.
Najafabad Iran (Islamic Republic of) 8514143131 +98 31 4229 2583 faridokht.yazdani@yahoo.com Islamic Azad University Iran (Islamic Republic of) Patients aged 15 to 75 who have been diagnosed with grade I to III breast cancer based on pathology; Have completed intensive breast cancer treatment (including surgery, chemotherapy, or radiation therapy); Have the recommendation and permission to participate in the exercises program from the oncologist; Three weeks after chemotherapy or radiation therapy; Less than 6 months have passed since chemotherapy or radiation therapy; Patients should be able to do aerobic and resistance exercises. 15 years 75 years Female Having an acute illness or a serious psychiatric illness; Patients with recurrence or metastasis; Suffering from other diseases or other continuous treatments such as asthma or osteoporosis and heart disease and blood pressure; Anemia with a decrease in red blood cells; Ataxia (imbalance in walking); Patients have not been approved by the oncologist for exercise. C50 Malignant neoplasm of breast Rehabilitation Rehabilitation Intervention group: intervention group: exercise group; They receive an exercise program including 12-week supervised exercises developed by a sports physiologist, 3 days a week for 50-60 minutes. This program will include aerobic exercises, resistance exercises, flexibility exercises and balance exercises. Aerobic exercise class consists of three parts: warm-up, aerobic exercises, and cool-down. Control group: Patients in the control group only do their normal physical activities and are provided with educational brochures about routine care. The coping self-efficacy score in the questionnaire has 3 dimensions (stopping emotions and unpleasant thoughts), (problem-oriented strategy), and (receiving support from family and friends). The total scores for each item of that dimension are calculated together. Respondents must answer at least 80% of the scale items. Timepoint: Measuring coping self-efficacy at the beginning of the study (before the start of the intervention) and at the end of the intervention (12 weeks after the start of the study). Method of measurement: Chesney et al. Coping Self-Efficacy Questionnaire (CSES). The quality of life score of breast cancer patients in the QLQ-Br23 questionnaire includes 23 items that are divided into two dimensions. The first dimension includes four functional scales, (sexual function, sexual pleasure, and future perspective); While the second dimension includes four symptom scales (systemic treatment side effects, breast symptoms, arm symptoms, hair loss discomfort). Each item is scored from 1 to 4 points. Scores are converted to a 0-100 score after linear transformation. The highest scores correspond to better performance (except for sexual performance and sexual pleasure). On the other hand, higher scores on the symptom scale dimension are associated with higher persistence of signs and symptoms. Timepoint: Measuring quality of life at the beginning of the study (before the start of the intervention) and at the end of the intervention (12 weeks after the start of the study). Method of measurement: Breast Cancer Quality of Life Questionnaire (EORTC-QLQ-BR23). Reduce anxiety. Timepoint: End of the intervention (after 12 weeks from the start of the intervention). Method of measurement: Hospital Anxiety and Depression Scale (HADS). Islamic Azad University Approved 2023-10-05 Islamic Azad University-Najafabad branch Islamic Azad University, Najaf Abad branch, University Boulevard Najafabad Isfehan Iran (Islamic Republic of)