Effects of 8 weeks of aerobic exercise and vitamin D supplementation on serum levels of brain-derived neurotrophic factor, quality of life, and some cognitive and psychological indices in Migraine patients

Effect of 8 weeks of aerobic exercise and vitamin D supplementation on serum levels of brain-derived neurotrophic factor (BDNF), quality of life, severity, duration, and frequency of migraine attack, memory performance, cognitive impairment, depression severity, quality of sleep, and physical self-esteem in Migraine patients

A randomized, single-blind clinical trial with a control group, parallel groups on 48 patients, block randomization via www.randomization.com

This study is conducted at Razi University. First, the study variables are measured, and then, 4 experimental groups perform the prescribed interventions. Then, the variables are measured again. Participants and investigators will be blinded and, tablets identical to vitamin D tablets will be used.

Inclusion Criteria: Not participation in regular exercise over the last 6 months Having Migraine without aura Getting the certification of no prohibition of participating in the exercise training program from a specialist Insufficient values of Vitamin D (20-29 nanograms/milliliter) Aged between 20 to 50 years Exclusion Criteria: Any psychiatric disorders other than Migraine without aura Alcohol and other kinds of drug addiction Musculoskeletal disorders Cardiovascular and pulmonary diseases Refusal to give informed consent

1) Exercise + Vitamin D: Aerobic exercise 3 times a week for 8 weeks and weekly supplementation of vitamin D 2) Exercise + Placebo: Aerobic exercise 3 times a week for 8 weeks and weekly consumption of placebo tablets; 3) Vitamin D: Weekly supplementation of vitamin D for 8 weeks; 4) Control: Weekly consumption of placebo for 8 weeks

Changes in brain-derived neurotrophic factor, quality of life, variables of migraine, memory, cognitive performance, depression, quality of sleep,

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 48-digit sequence (equal to sample size) will be created. Then, treatment labels including 1) Exercise + Vitamin D group; 2) Exercise + Placebo group; 3) Vitamin D group, and 4) 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, 6, or 8). 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.

The present study is single-blind in which participants are blinded about receiving vitamin D or placebo while, based on the nature of exercise training, there will be no blinding for exercise interventions. For blinding 2 groups not receiving vitamin D, tablets with identical characteristics, color, taste, and smell with vitamin D tablets will be prepared as the placebo, and none of the subjects will be aware of the status of the supplementation.

All data are shared after the de-identification of the participants

3 months after publication

All individuals upon formal request

Data sharing requests are accepted for any purposes

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

Upon formal request, mentioning due reasons, and providing full personality details, data will be sent after 72 h via e-mail