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IRCT20250403065195N1 IRCT 2025-04-28 The University of Razi Studying the effects of aerobic exercise and vitamin E on depression severity and mental health in women with depressive symptoms Investigating the Effects of eight weeks Aerobic Training and Vitamin E consumption on depression Severity and Some Mental Health Indicators in Women with Depressive Symptoms 2025-04-30 anticipated 48 Complete https://irct.ir/trial/82692 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the block randomization method will be used through the website www.randomization.com. For this purpose, first, each subject is assigned a number as a unique identification code and a 48-digit sequence (equal to the sample size) is created. Then, the names of the intervention groups including 1) exercise + vitamin E group; 2) exercise + placebo group; 3) vitamin E group; 4) control group will be defined in the relevant section of the website. After defining the groups and in order to prevent potential problems caused by blocking with fixed-size blocks, the method of randomly selecting blocks with different sizes will be used for blocking. In this case, with the sample size being known, the block sizes will be unequal and a multiple of the number of intervention groups (for example, blocks with sizes of 2, 4, 6 or 8). The website has the ability to randomly create sequences of blocks with different sizes. In the final step, by executing the Generate Plan command on the website, all subjects are randomly assigned to blocks of different sizes that themselves have a random sequence. Finally, by using the number (code) assigned to each subject and examining the blocks, the group of each subject will be determined, Blinding description: The present study will be conducted in a single-blinded manner and participants will be kept blind to the intake of vitamin E or placebo, while due to the nature of exercise training, blinding will not be done in this case (exercise intervention). In order to blind the two groups that do not receive vitamin E tablets, tablets similar to vitamin E tablets in terms of appearance, smell, taste and color will be used as placebos, and information regarding vitamin E and placebo intake will be kept secret from the subjects. N/A Depression. Intervention 1: Intervention group: Continuous aerobic exercise, including 3 training sessions per week for 8 weeks. In the first week, the exercises will be performed for 20 minutes at an intensity of 50% of the heart rate reserve, and the intensity and duration of the exercise will be gradually increased. Finally, in the eighth week, the duration of the exercises will be 40 minutes and the intensity of the exercises will be equivalent to 60% of the heart rate reserve. This group will also receive 15 mg of vitamin E daily in the form of oral tablets. Intervention 2: Intervention group: Continuous aerobic exercise, consisting of 3 training sessions per week for 8 weeks. In the first week, the exercises will be performed for 20 minutes at an intensity of 50% of the heart rate reserve, and the intensity and duration of the exercise will be gradually increased. Finally, in the eighth week, the duration of the exercises will be 40 minutes and the intensity of the exercises will be equivalent to 60% of the heart rate reserve. This group will also receive placebo pills, which are completely identical to vitamin E pills, daily. Intervention 3: Intervention group: This group will receive 15 mg of vitamin E in the form of oral tablets daily for 8 weeks. Intervention 4: Control group: This group will have a normal life for 8 weeks and during this period, they will receive placebo pills, which are completely identical to vitamin E pills, daily. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying the subjects. When: 3 months after results are published To whom: All persons upon formal request Conditions: Meta-Analysis Studies Where to obtain: If you need to receive documents, please send an email to Ehsan Amiri, a faculty member at Razi University, at the following email address: e.amiri@razi.ac.ir. How to obtain: In case of formal request, stating the relevant reasons and providing full details, the data will be sent via email after 72 hours. Comments:
public Ehsan Amiri
Room 73, Faculty of Sport Sciences, Razi University, Daneshgah St., Taq Bostan
kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 e.amiri@razi.ac.ir The University of Razi scientific Ehsan Amiri
Room 73, Faculty of Sport Sciences, Razi University, Daneshgah St., Taq Bostan
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 e.amiri@razi.ac.ir The University of Razi Iran (Islamic Republic of) Age range 18 to 50 years Resident of Kermanshah city Body mass index (BMI) less than 29.9 kg/m2 Having depressive symptoms (score of 16 or higher on the Center for Epidemiological Studies Depression Scale) 18 years 50 years Female Presence of musculoskeletal abnormalities or disorders Participation in a regular exercise program in the past 6 months Taking supplements with anti-inflammatory properties F32.0 Major depressive disorder, single episode, mild Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Continuous aerobic exercise, including 3 training sessions per week for 8 weeks. In the first week, the exercises will be performed for 20 minutes at an intensity of 50% of the heart rate reserve, and the intensity and duration of the exercise will be gradually increased. Finally, in the eighth week, the duration of the exercises will be 40 minutes and the intensity of the exercises will be equivalent to 60% of the heart rate reserve. This group will also receive 15 mg of vitamin E daily in the form of oral tablets. Intervention group: Continuous aerobic exercise, consisting of 3 training sessions per week for 8 weeks. In the first week, the exercises will be performed for 20 minutes at an intensity of 50% of the heart rate reserve, and the intensity and duration of the exercise will be gradually increased. Finally, in the eighth week, the duration of the exercises will be 40 minutes and the intensity of the exercises will be equivalent to 60% of the heart rate reserve. This group will also receive placebo pills, which are completely identical to vitamin E pills, daily. Intervention group: This group will receive 15 mg of vitamin E in the form of oral tablets daily for 8 weeks. Control group: This group will have a normal life for 8 weeks and during this period, they will receive placebo pills, which are completely identical to vitamin E pills, daily. Change in severity of depression. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Standard questionnaire of the Center for Epidemiological Studies. Change in quality of life. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Use of the Mental Health Quality of Life (MHQoL) questionnaire. Change in sleep quality. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Using the Pittsburgh Sleep Quality Questionnaire. Self-concept review. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Using the Robson Self-Concept Questionnaire. Change in self-esteem. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Using the Rosenberg Self-Esteem Scale. Change in memory status. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Using the standard MCS questionnaire (Memory Complaints Scale) to assess memory status. General fatigue assessment. Timepoint: Before the start of the intervention and 8 weeks after the start of the intervention. Method of measurement: Using the Multidimensional Fatigue Index (MFI) questionnaire. The University of Razi Approved 2025-03-14 Razi University Research Ethics Committee Room 73, Faculty of Sport Sciences, Razi University, Daneshgah St., Taq Bostan Kermanshah Kermanshah Iran (Islamic Republic of)