The general purpose of this research is to investigate the effect of a combined exercise protocol (aerobic resistance) on microRNAs involved in pain, inflammation and fatigue in MS patients.
Design
First, we randomly divided 36 men and women with relapsing-remitting MS into control and exercise groups.
The randomization method will be simple.
Then the training group starts to do the training protocol for 8 weeks while the control group does not do any training during these 8 weeks.
Settings and conduct
The study site will be the MS Research Center of Sinai Hospital.
Participants/Inclusion and exclusion criteria
The main criteria for entering the research
Male and female patients with MS with EDSS 1 to 4
Only patients using interferon-beta medication alone will participate in the study.
Age range from 25 to 45 years
Lack of regular physical activity in the last 6 months
Ability to perform sports protocol
The main criteria for exiting the research
Worsening of the patient's condition
Inability to complete the exercise protocol
The beginning of the relapse period
Intervention groups
The intervention considered in this research is 8 weeks of combined sports training (aerobic-resistance) which only the training group will be able to do, and the control group will not have any sports activities during these 8 weeks.
Main outcome variables
The main variables considered in this research are micro RNAs involved in pain, inflammation and fatigue of MS patients, which will include miR-155, miR-326, miR-23b, miR146a.
Also, the amount of pain, quality of sleep, quality of life, time to reach fatigue and EDSS score are other variables considered for measurement.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230618058515N1
Registration date:2023-07-04, 1402/04/13
Registration timing:prospective
Last update:2023-07-04, 1402/04/13
Update count:0
Registration date
2023-07-04, 1402/04/13
Registrant information
Name
mohammad torab
Name of organization / entity
Tehran university
Country
Iran (Islamic Republic of)
Phone
+98 41 3525 4804
Email address
mohammad.torab@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-08, 1402/04/17
Expected recruitment end date
2023-07-15, 1402/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of combined exercise training (aerobic-resistance) on microRNAs involved in pain, inflammation and fatigue in patients with MS.
Public title
The effect of 8 weeks of combined exercise training (aerobic-resistance) on microRNAs involved in pain, inflammation and fatigue in patients with MS.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female patients with MS with EDSS 1 to 4
Only patients using interferon-beta medication alone will participate in the study.
Age range from 25 to 45 years
Lack of regular physical activity in the last 6 months
Ability to perform sports protocol
Exclusion criteria:
Worsening of the patient's condition
Inability to complete the exercise protocol
The beginning of the relapse period
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Randomization unit: individual
The randomization method will be a coin toss.
Usually, this method is used to create a random sequence in two-group experiments in such a way that one of the studied groups is considered a lion and the other group is considered a line, and based on the desired sample size, the same number of coins are thrown. and people are divided into two groups. They find it by accident.
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 of Neuroscience Research Institute <<Neural Rehabilitation>>
Street address
No. 2-4th West Dead End-Shahid Naqeibi Alley-Kamali St.-Tehran
City
Tehran
Province
Tehran
Postal code
1331777463
Approval date
2023-06-11, 1402/03/21
Ethics committee reference number
IR.TUMS.NI.REC.1402.006
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
miR-155 , miR-326, miR-23b, miR-146a
Timepoint
Before starting the training program and 24 hours after the last training session
Method of measurement
RT-PCR
Secondary outcomes
1
Description
Sleep quality
Timepoint
Before starting the training program and 24 hours after the last training session
Method of measurement
In order to measure the effect of the combined exercise program on the sleep quality of these patients, the Sleep Quality Questionnaire (PSQI) will be used.
2
Description
Quality of Life
Timepoint
Before the start of the training program and after the end of the training program
Method of measurement
In order to measure the effect of the combined exercise program on the quality of life of these patients, the quality of life questionnaire of MS patients (MSQOL-54) will be used.
3
Description
Fatigue rate
Timepoint
Before starting the training program and after it ends
Method of measurement
In order to measure the effect of the combined exercise program on the fatigue level of this patient, the comprehensive fatigue assessment scale in patients with MS (CFAB-MS) from the questionnaire related to fatigue in these patients will be used.
4
Description
The amount of pain
Timepoint
Before starting the training program and after it ends.
Method of measurement
The McGill Pain Questionnaire (SF-MPQ) will be used to measure the effect of the combined exercise program on the pain level of these patients.
5
Description
EDSS
Timepoint
Before starting the training program and after its termination
Method of measurement
by a neurologist
6
Description
Time to get tired
Timepoint
Before starting the training program and after its termination
Method of measurement
6 minute walk test
Intervention groups
1
Description
Intervention group: The intervention group (exercise) will be monitored for 8 weeks to start sports activities. In this way, two sessions of aerobic exercise per week using a stationary bike and two sessions per week of resistance exercise using bodybuilding machines are performed in the form of knee flexion and extension. Before starting the training program, all movements are closely taught to the returnees.
Category
Rehabilitation
2
Description
Control group: control The control group will avoid any planned and regular physical activity during the time that the training group is doing the activity.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sinai Hospital MS Research Center
Full name of responsible person
Dr. Maryam Abolhasani
Street address
Sina Hospital- Narsideh to Hasan Abad Square- Imam Khomeini St.-Tehran
City
Tehran
Province
Tehran
Postal code
۱۱۳۶۷۴۶۹۱۱
Phone
+98 21 6634 8571
Email
info@sinaih.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute of Neuroscience, Faculty of Medical Sciences, Tehran
Full name of responsible person
Dr. Akbar Fatuhi
Street address
Reyhaneh Building - Imam Khomeini Hospital - End of Keshavarz Boulevard - Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۳۹
Phone
+98 21 6658 1701
Fax
Email
tini@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sinai Hospital MS Research Center
Proportion provided by this source
10
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university
Full name of responsible person
Mohammad Torab
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Tehran, Kamali St., Shahid Naqibi Alley, No. 4, Unit 2
City
Tehran
Province
Tehran
Postal code
1331777463
Phone
+98 41 3525 4804
Fax
Email
mohammad.torab@ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university
Full name of responsible person
Mohammad Torab
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Tehran, Kamali St., Shahid Naqibi Alley, No. 4, Unit 2
City
Tehran
Province
Tehran
Postal code
1331777463
Phone
+98 41 3525 4804
Fax
Email
mohammad.torab@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran university
Full name of responsible person
Mohammad Torab
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Tehran, Kamali St., Shahid Naqibi Alley, No. 4, Unit 2
City
Tehran
Province
Tehran
Postal code
1331777463
Phone
+98 41 3525 4804
Fax
Email
mohammad.torab@ut.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the completion of the research, all the data of this research will be published with full interpretation in the form of student thesis and scientific-research articles.
When the data will become available and for how long
It is expected that data related to this research will be available from February 1402.
To whom data/document is available
All researchers in the field of clinical sports physiology and specialist doctors can access these data after the publication of articles from the project.
Under which criteria data/document could be used
The current research is an applied research and the data and protocol obtained from this plan are used to prevent the severity of the disease.
From where data/document is obtainable
To get the raw data, you can refer to the main researchers of this project (Mr. Mohammad Torab, Dr. Mohammad Reza Kordi, and Ms. Dr. Maryam Abolhasani).
What processes are involved for a request to access data/document
In order to receive data, the researcher must submit an official request to the university and the research institute where he is working, in which it is clearly stated for what purpose he wants to use this data and whether this data is effective in advancing his research.