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IRCT20210617051606N3 IRCT 2021-10-27 Razi University Effects of exercise training and vitamin D supplementation on Migraine 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 2021-10-07 anticipated 48 Complete https://irct.ir/trial/58967 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: 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 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, Blinding description: 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. N/A Migraine without aura. Intervention 1: Intervention group: 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 week 8, the time of training will be 40 minutes and the intensity will be 60% of heart rate reserve. This group also receives 50000 International Units of vitamin D in the form of oral tablets every week. Intervention 2: Intervention group: 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 week 8, the time of training will be 40 minutes and the intensity will be 60% of heart rate reserve. This group also receives placebo tablets identical to vitamin D tablets every week. Intervention 3: Intervention group: This group receives 50000 International Units of vitamin D in the form of oral tablets every week for 8 weeks. Intervention 4: Control group: Normal life during the study plus receiving placebo tablets identical to vitamin D tablets every week. 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) Not participation in regular exercise over the last 6 months Having Migraine without aura confirmed by a specialist 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 20 years 50 years Male Any psychiatric disorders other than Migraine without aura Alcohol and other kinds of drug addiction Musculoskeletal disorder Cardiovascular and pulmonary diseases Refusal to give informed consent G43.0 Migraine without aura Other Other Other Other Intervention group: 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 week 8, the time of training will be 40 minutes and the intensity will be 60% of heart rate reserve. This group also receives 50000 International Units of vitamin D in the form of oral tablets every week. Intervention group: 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 week 8, the time of training will be 40 minutes and the intensity will be 60% of heart rate reserve. This group also receives placebo tablets identical to vitamin D tablets every week. Intervention group: This group receives 50000 International Units of vitamin D in the form of oral tablets every week for 8 weeks. Control group: Normal life during the study plus receiving placebo tablets identical to vitamin D tablets every week. 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). Changes in severity, duration, and frequency of Migraine attacks. Timepoint: Before starting the intervention, and 8 weeks after starting the intervention. Method of measurement: By the use of researcher-made questionnaire to record the pertinent variables of Migraine attacks. Changes in memory performance. Timepoint: Before starting the intervention, and 8 weeks after starting the intervention. Method of measurement: By the use of Subjective Memory Complaints Scale. Changes in cognitive performance. Timepoint: Before starting the intervention, and 8 weeks after starting the intervention. Method of measurement: By the use of Ascertain Dementia 8 (AD8) questionnaire. Changes in depression severity. Timepoint: Before starting the intervention, and 8 weeks after starting the intervention. Method of measurement: By the use of Beck’s Depression Inventory. Change in the quality of sleep. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Pittsburgh Sleep Quality Index. Change in physical self-concept. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: Physical self-concept questionnaire. 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)