Protocol summary

Study aim
We hypothesized that moderate aerobic training lowers the serum level of S100B and MDA or increases the serum level of SOD and improves headache indices and general health status in wMIG.
Design
The study is a randomized controlled clinical trial (RCT) with a semi-experimental design (three groups with pre- and post-testing).
Settings and conduct
Imam reza Hospital, Kermanshah
Participants/Inclusion and exclusion criteria
The inclusion criteria were as follows: (1) no history of regular exercise in the previous 6 months; (2) no chronic diseases such as cardiovascular, hypertension, diabetes, arthritis, cancer, asthma, AIDS, meningitis or MS; (3) confirming headache by the neurologist; (4) Having an age range of 18 to 45 years. Exclusion criteria comprised: (1) situations that researchers understood during the research period, such as pregnancy, breastfeeding and abuse of drugs or alcohol; (2) participation in any additional exercise training programmes; (3) no interest on the part of the volunteer in continuing or making a change in their personal life schedule; (4) contracting COVID-19, and 5) voluntary finished the protocol.
Intervention groups
1) exercise+migraineurs group (doing 8 weeks of endurance exercise training, running and taking medicine prescribed by the doctor). 2) non-exercise+migraineurs group (only taking medicine prescribed by the doctor). 3. A healthy control group (without medicine and healthy).
Main outcome variables
matrix metalloproteinases-2 (MMP-2), matrix metalloproteinases-9 (MMP-9), Inhibitors of matrix metalloproteinases-1(TIMP-1),Inhibitors of matrix metalloproteinases-2 (TIMP-2), S100 calcium-binding protein B(S100B)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120912010824N4
Registration date: 2023-09-30, 1402/07/08
Registration timing: retrospective

Last update: 2023-09-30, 1402/07/08
Update count: 0
Registration date
2023-09-30, 1402/07/08
Registrant information
Name
Abdolhossein Parnow
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 1428 3275
Email address
a.parnow@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-30, 1400/02/10
Expected recruitment end date
2021-07-11, 1400/04/20
Actual recruitment start date
2021-05-10, 1400/02/20
Actual recruitment end date
2021-11-06, 1400/08/15
Trial completion date
2023-09-21, 1402/06/30
Scientific title
The Effect of 8 Weeks of Aerobic endurance Exercise Training with Moderate Intensity on Permeability Inflammatory Indicators of Matrix Metalloproteinases and Specific Tissue Inhibitors of MMPs in Migraine Patients
Public title
Moderate aerobic exercise and Migraine disease
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
no chronic diseases such as cardiovascular, hypertension, diabetes, arthritis, cancer, asthma, AIDS, meningitis or MS no history of regular exercise in the previous 6 months confirming headache by the neurologist
Exclusion criteria:
contracting COVID-19
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 45
Actual sample size reached: 43
Randomization (investigator's opinion)
Randomized
Randomization description
First, for the two groups of training and control patients, according to the entry and exit criteria, 30 people were introduced by the attending physician of the Kermanshah migraine patient community. A simple random model was used to divide into two groups, and a random number table tool was used for this model. The random sequence was prepared using Random software. For the healthy group, 15 people were selected as available sampling.
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
Research Working Group at the Sports Sciences Research Institute
Street address
Motahari Street
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2022-06-24, 1401/04/03
Ethics committee reference number
IR.SSRC.REC.1402.100

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
matrix metalloproteinases (MMPs) and specific tissue inhibitors of MMPs
Timepoint
48 hours before and after the training protocol
Method of measurement
blood sampling

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the group of migraine patients who underwent 12 weeks of indoor aerobic exercise training, which lasted three sessions a week for one hour in each session.
Category
Rehabilitation

2

Description
Control group: group of migraine patients without exercise training.
Category
Rehabilitation

3

Description
Control group: group of healthy people without any disease and without exercise.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان امام رضا کرمانشاه
Full name of responsible person
زهرا پیرو
Street address
سرخه لیژه
City
کرمانشاه
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3428 3276
Email
parnowabdolhossein@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Payam Sari Aslani
Street address
sorkhe lisheh
City
Kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 912 831 5374
Email
psariaslani@kums.ac.ir
Grant name
no funded
Grant code / Reference number
00
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Pairo
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
0834283276
Email
zahrapairo@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Abdolhossein Parnow
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
exercise physiology
Street address
Razi university
City
Kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3428 3276
Email
parnowabdolhossein@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Abdolhossein Parnow
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
exercise physiolgy
Street address
Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3428 3276
Email
parnowabdolhossein@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
No known time
When the data will become available and for how long
No known time
To whom data/document is available
researchers
Under which criteria data/document could be used
Research using
From where data/document is obtainable
Corrsponding author
What processes are involved for a request to access data/document
Email
Comments
No
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