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IRCT20210617051606N1 IRCT 2021-09-07 Razi University Effect of exercise training on depression The effect of 8 weeks continuous and sprint-interval aerobic training on serum brain-derived neurotrophic factor (BDNF)levels, quality of life, depression severity, and some psycho-cognitive indices in depressed men 2021-09-11 anticipated 42 Complete https://irct.ir/trial/57026 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 42-digit sequence (equal to sample size) will be created. Then, treatment labels including sprint-interval training group, continuous aerobic group, and 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 3, 6, or 9). 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 Depression Disorder. Intervention 1: Intervention group 1: continuous aerobic exercise for 8 weeks and 3 sessions per week. In the first week, the duration of training will be 20 minutes and the intensity will be 50% of heart rate reserve. Gradually, the time and intensity of training increase and at the week 8, the time of training will be 40 minutes and the intensity will be 60% of heart rate reserve. Intervention 2: Intervention group 2: sprint interval training for 8 weeks and 3 sessions per week. In the first week, training includes 4 bouts of all-out sprint with 120 seconds rest among bouts (1:6 work to recovery ratio). Gradually, the training load increases and at week 8, the training includes 8 bouts of all-out sprint with 60 seconds rest among bouts (1:2 work to recovery ratio). Intervention 3: Control group: 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
Room 73. Faculty of Sport Sciences, Razi University, University St, Taq-e-Bostan, Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 7609 e.amiri@razi.ac.ir Razi University scientific Ehsan Amiri
Room 73. Faculty of Sport Sciences, Razi University, University St, Taq-e-Bostan, Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 7609 e.amiri@razi.ac.ir Razi University Iran (Islamic Republic of) Not participation in regular exercise training over the last 6 months Having moderate depression confirmed by a specialist Getting the certification of no prohibition of participating in exercise training program from a specialist 18 years 50 years Male Any other psychiatric disorder other than depression Alcohol or substance addiction Inability to perform exercise interventions Cardiovascular and pulmonary diseases Obesity (body mass index more than 30) Refusal to give informed consent F32.1 Major depressive disorder, single episode, moderate Other Other Other Intervention group 1: continuous aerobic exercise for 8 weeks and 3 sessions per week. In the first week, the duration of training will be 20 minutes and the intensity will be 50% of heart rate reserve. Gradually, the time and intensity of training increase and at the week 8, the time of training will be 40 minutes and the intensity will be 60% of heart rate reserve. Intervention group 2: sprint interval training for 8 weeks and 3 sessions per week. In the first week, training includes 4 bouts of all-out sprint with 120 seconds rest among bouts (1:6 work to recovery ratio). Gradually, the training load increases and at week 8, the training includes 8 bouts of all-out sprint with 60 seconds rest among bouts (1:2 work to recovery ratio). Control group: normal life during the study Change in serum levels of brain-derived neurotrophic factor. Timepoint: Before starting the intervention, and 8 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 8 weeks after starting the intervention. Method of measurement: World health organization standard quality of life questionnaire (short version). Change in depression severity. Timepoint: Before starting the intervention, and 8 weeks after starting the intervention. Method of measurement: Hamilton Depression Rating Scale. Change in cognitive flexibility. Timepoint: Before starting the intervention, and 8 weeks after starting the intervention. Method of measurement: The 20-item cognitive flexibility inventory (Dennis and Vander Wal). Change in physical self-concept. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Physical self-concept questionnaire. Change in the quality of sleep. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Pittsburgh Sleep Quality Index. Change in anxiety. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Beck Anxiety Inventory. Change in self-esteem. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Rosenberg’s Self-Esteem Scale. Razi University Approved 2021-06-02 Research Ethics Committees of Kermanshah Razi University Room. 73, Faculty of Sport Sciences, Razi University, University Str, Taq-e-bostan, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)