Determining the effect of combination of Mg, B12, and intense aerobic exercise on CGRP in women with migraine
Design
A controlled clinical trial with a parallel-group design of 60 Subjects, Randomized by simple randomization method, Phase 2; on 60 patients
Settings and conduct
In this quasi-experimental study, by referring to the office of Dr. Chitsaz, a neurologist, 60 subjects are selected and divided into four groups. Blood samples are taken from patients 48 hours before the start and after the implementation of the training protocol.
Intervention group 1: Aerobic exercises, including training with Astrand bike with 60% of maximum heart rate in the first week and 85% of maximum heart rate in the eighth week.
Intervention group 2: Supplementation group: One 250 mg magnesium and 1 mg tablets daily Intervention group 3: Aerobic exercises and supplementation. Control group: No intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmation of migraine by a doctor. Exclusion criteria: Do not take food supplements in the last 3 months; Lack of sports history in the last 6 months
Intervention groups
Intervention group 1: Aerobic exercises, including training with Astrand bike with 60% of maximum heart rate in the first week and 85% of maximum heart rate in the eighth week.
Intervention group 2: Supplementation group: One 250 mg magnesium and 1 mg tablets daily Intervention group 3: Aerobic exercises and supplementation. Control group: No intervention
Main outcome variables
Calcitonin Gene-Related Peptide
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170510033909N12
Registration date:2021-07-14, 1400/04/23
Registration timing:prospective
Last update:2021-07-14, 1400/04/23
Update count:0
Registration date
2021-07-14, 1400/04/23
Registrant information
Name
فرزانه تقیان
Name of organization / entity
دانشگاه آزاد اسلامی.واحد اصفهان
Country
Iran (Islamic Republic of)
Phone
+98 913 308 0241
Email address
f.taghian@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined combination of Mg, B12 and intense aerobic exercise on CGRP in women with migraine
Public title
Exercise and migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of migraine by a doctor
Exclusion criteria:
Do not take food supplements in the last 3 months
Lack of sports history in the last 6 months
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization;
Randomization Tool: Random Number Table;
Randomization Unit: Individual;
In order to use a table of random numbers, the researcher will first determine the reading position of the table numbers.
The numbers will then be considered for different groups. For example, zero to twenty-four for intervention A, twenty-five to forty-nine for intervention B, fifty to seventy-four for group C, and seventy-five to nine for group D.
Then we will touch one of the numbers and move in one of the predetermined directions. The numbers will be recorded and assigned to four groups: aerobic exercise, Mg intake, B12, combination and control.
In order to hide random allocation, the method of coded boxes with random sequence will be used. This method uses a number of boxes that are numbered randomly. Adequate sealing of the boxes, their apparent similarity and their weight will be ensured.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Research Islamic Azad University - Isfahan Branch (Khorasgan)
Street address
University Blvd, Arghavanie, East Gay Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2021-06-02, 1400/03/12
Ethics committee reference number
IR.IAU.KHUISF.REC.1400.056
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Calcitonin Gene-Related Peptide
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Serum concentration of CGRP by ELISA method using the Eastbiopharm Monobind CHINA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 : Intense aerobic exercise:The training program consists of three parts: warm-up, main stage and cooling. The warm-up and cooling phase includes 10 minutes and the main phase of training with the Astrand bike with 60% of the maximum heart rate in the first week and 85% of the maximum heart rate in the eighth week.
Category
Rehabilitation
2
Description
Intervention group 2 : One tablet of 250 mg of magnesium and 1 mg of B12 daily for 8 weeks
Category
Lifestyle
3
Description
Intervention group 3 : Supplementation and aerobic exercise:Exercise program includes exercise with Astrand bike with 60% of maximum heart rate in the first week and 85% of maximum heart rate in the eighth week. Take one 250 mg magnesium and 1 mg B12 tablet daily for 8 weeks.
Category
Lifestyle
4
Description
Control group: No intervention, only follow up
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurologist
Full name of responsible person
Ahmad Chitsaz
Street address
Arad building, next to Sina hospital, Shamsabadi street
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3220 4715
Email
Chitsaz@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy
Full name of responsible person
Majid Toghyani
Street address
Khorasgan University, Arghavanie St, Isfaha
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2352
Email
F_taghian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzaneh taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183895183
Phone
+98 31335002352
Email
F_taghian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farzaneh Taghian
Full name of responsible person
Islamic Azad University
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183895153
Phone
+98 81 8389 5183
Email
F_taghian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Farzaneh Taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University , Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2352
Email
F_taghian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available