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

Determining the effects of eight weeks of continuous aerobic exercise and vitamin E supplementation on depression severity, quality of life, self-confidence, sleep quality, self-concept, memory function, and general fatigue in women with depressive symptoms

A controlled, parallel-group, single-blind, block-randomized clinical trial on 48 patients with depression. The website www.randomization.com will be used for randomization.

This study will be conducted at Razi University. First, the research variables will be measured. Then, 4 groups of participants in the study will receive the desired interventions. After the interventions are completed, the research variables will be measured again. In this study, participants will be blinded. Tablets similar to vitamin E tablets will be used as placebo.

Inclusion criteria: - 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) Exclusion criteria: - Presence of musculoskeletal abnormalities or disorders - Participation in a regular exercise program in the past 6 months - Taking supplements with anti-inflammatory properties

1) Exercise + Vitamin E: Three aerobic exercise sessions per week for 8 weeks and daily vitamin E supplementation 2) Exercise + Placebo: Three aerobic exercise sessions per week for 8 weeks and daily placebo pill intake 3) Vitamin E: Daily vitamin E supplementation for 8 weeks 4) Control: Daily placebo pill intake for 8 weeks

Changes in depression severity, quality of life, sleep quality, self-concept, self-esteem, memory status, general fatigue

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.

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.

All data can be shared after de-identifying the subjects.

3 months after results are published

All persons upon formal request

Meta-Analysis Studies

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.

In case of formal request, stating the relevant reasons and providing full details, the data will be sent via email after 72 hours.