]>
IRCT20210617051606N4 IRCT 2021-11-21 Razi University Exercise and Breast Cancer During COVID-19 Pandemic The effect of 16 weeks of concurrent home-based exercise on some physiological, psychological, functional, and anthropometric indices in females with breast cancer during the COVID-19 pandemic 2021-11-26 anticipated 28 Complete https://irct.ir/trial/60066 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, permuted block randomization via the www.randomization.com website will be used. To do so, first, a unique number will be allocated to each subject as the identifier code and, a 28-digit sequence (equal to sample size) will be created. Then, treatment labels including 1) Exercise group; 2) Control group will be entered in the relevant section on the website. After defining the treatment groups and to avoid potential problems associated with equal block sizes, permuted block randomization with differents block sizes will be applied. In this case, by knowing the sample size, the block sizes will be unequal and a multiple of the number of treatment groups (for example, block sizes of 2, 4, or 6). The website has the ability to randomly specify the sequence of blocks with different sizes. In the final step and upon performing the 'Generate Plan' on the website, all subjects will be randomly assigned to blocks of different sizes that already have a random sequence. Finally, the group (treatment) of each subject will be specified by the use of the identifier code and checking out the blocks. N/A Breast Cancer. Intervention 1: Intervention group: This group performs home-based concurrent training including body-weight resistance training and step aerobic 2 times per week for 16 weeks. The training program consists of 3 phases including phase A (4 weeks), phase B (6 weeks), and phase C (6 weeks). The training variables including the intensity, time, and volume of training will gradually increase within 16 weeks. The training type will also change in different phases of the program. The intensity of aerobic and resistance training will be controlled by the use of the Borg Scale and monitoring the heart rate. In each session, participants first perform body-weight resistance training which includes specified cycles with defined rest periods, and then, they do step aerobic according to the instructions. 10 min of warm-up and 10 min of cool-down will be devoted to each session. Intervention 2: Control group: this group has the the normal life during the study. Yes - There is a plan to make this available What will be shared: All data are shared after the de-identification of the participants When: 3 months after publication To whom: All individuals upon formal request Conditions: Data sharing requests are accepted for any purposes Where to obtain: To obtain any data/document, please send an e-mail to Ehsan Amiri, a faculty member at Razi University, through the following e-mail address: e.amiri@razi.ac.ir How to obtain: Upon formal request, mentioning due reasons, and providing full personality details, data will be sent after 72 h via e-mail Comments:
public Ehsan Amiri
No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 e.amiri@razi.ac.ir Razi University scientific Ehsan Amiri
No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 e.amiri@razi.ac.ir Razi University Iran (Islamic Republic of) Diagnosed with breast cancer by a specialist No signs of relapse or tumor metastasis No less than 3 months and more than 5 years passed from the last cancer-specific treatment (chemotherapy or radiotherapy) Not participating in regular exercise training within last 6 months 18 years 50 years Female Cardiovascular and pulmonary diseases Alcohol and other kinds of drug addiction Musculoskeletal disorder Pregnancy Refusal to give informed consent C50 Malignant neoplasm of breast Other Other Intervention group: This group performs home-based concurrent training including body-weight resistance training and step aerobic 2 times per week for 16 weeks. The training program consists of 3 phases including phase A (4 weeks), phase B (6 weeks), and phase C (6 weeks). The training variables including the intensity, time, and volume of training will gradually increase within 16 weeks. The training type will also change in different phases of the program. The intensity of aerobic and resistance training will be controlled by the use of the Borg Scale and monitoring the heart rate. In each session, participants first perform body-weight resistance training which includes specified cycles with defined rest periods, and then, they do step aerobic according to the instructions. 10 min of warm-up and 10 min of cool-down will be devoted to each session. Control group: this group has the the normal life during the study Change in serum levels of Cortisol. Timepoint: Before starting the intervention, and 16 weeks after starting the intervention. Method of measurement: By the use of blood sample and ELISA method. Change in quality of life. Timepoint: Before starting the intervention, and 16 weeks after starting the intervention. Method of measurement: Cancer quality of life questionnaire (EORTC-QOQ-C30). Changes in cancer-related fatigue. Timepoint: Before starting the intervention, and 16 weeks after starting the intervention. Method of measurement: By the use of Functional Assessment of Chronic Illness Therapy- Fatigue Scale (Version 4). Changes in body image. Timepoint: Before starting the intervention, and 16 weeks after starting the intervention. Method of measurement: By the use of standard cancer-specific 10-item body image scale. Changes in cardiovascular endurance. Timepoint: Before starting the intervention, and 16 weeks after starting the intervention. Method of measurement: By the use of sub-maximal 1-mile (1600 m) walking Rockport test. Changes in body composition. Timepoint: Before starting the intervention, and 16 weeks after starting the intervention. Method of measurement: By the use of bioelectrical impedance analysis. Changes in cognitive function. Timepoint: Before starting the intervention, and 16 weeks after starting the intervention. Method of measurement: By the use of Cognitive Failure Questionnaire (25 items). Razi University Approved 2021-10-20 Research Ethics Committees of Kermanshah Razi University Deputy of Research and Technology, Razi University, University Str, Taq-e-bostan, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)