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The Effect of Aerobic-cognitive Combined Training on Inflammatory factors and Mental fatigue in Multiple Sclerosis Patients

Protocol summary

Study aim
Determining the effect of Brightonic training on plasma levels of interleukin-17 (IL17), interleukin-4 (IL4), ratio of interleukin-17 to interleukin-4, Dual Task and functional test, PVT cognitive test, cognitive profile questionnaire of POMS mood modification, fatigue correction MFIS, St. Petersburg Sleep Quality and Vickery Quality of Life for MS Patients
Design
The research project will have 3 training and control groups, with parallel groups, blinded, randomized, on 45 patients. Simple randomization and toss throwing will be used for randomization.
Settings and conduct
The full implementation of this research project in the pre-test and post-test period will be done in the MS clinic of Imam Hossein hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with recurrent and clinically stable MS, a minimum disability (EDSS) below 3, the age range of 20 to 50 years. Exclusion criteria: cardiovascular disease, diabetes, thyroid disorders, gout, orthopedic restrictions, patients who have an attack 4 weeks before or during the project.
Intervention groups
Patients will be randomly divided into 3 groups: aerobic-cognitive training, aerobic training and control.
Main outcome variables
Brightonic training on plasma levels of interleukin-17 (IL17), interleukin-4 (IL4), interleukin-17 to interleukin-4 ratio, Dual Task and TUG functional test, PVT cognitive test, POMS mood profile cognitive questionnaire tests, modified fatigue MFIS will affect the quality of sleep in St. Petersburg and the quality of life of Vicky patients with MS.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211214053407N1
Registration date: 2021-12-28, 1400/10/07
Registration timing: prospective

Last update: 2021-12-28, 1400/10/07
Update count: 0
Registration date
2021-12-28, 1400/10/07
Registrant information
Name
sara farajnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2641 6337
Email address
sfarajnia2020@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-01, 1400/10/11
Expected recruitment end date
2022-03-02, 1400/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Aerobic-cognitive Combined Training on Inflammatory factors and Mental fatigue in Multiple Sclerosis Patients
Public title
The effect of exercise on fatigue in MS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The subjects used in this study will be patients with MS and all of them will use interferon. People with recurrent and clinically stable MS with a minimum of disability (EDSS) below 3 will be selected for this study. The age range of the subjects will be 20 to 50 years (based on the average age of the patients).
Exclusion criteria:
People with cardiovascular disease, diabetes, thyroid disorders, gout, and orthopedic restrictions Patients who have an attack 4 weeks before or during the project. No signing the consent form approved by the Research Ethics Committee
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in this study will be divided into 3 groups of aerobic-cognitive training, aerobic training, and control by simple randomization method and by throwing baldness. The division is such that the names of all the candidates will be written on a piece of paper and the names of each bald person will be placed in front of it. 5 and 6 are also considered for the division of the control group. It should also be noted that if the quorum of each group reaches the quorum, the numbers belonging to that group will be awarded equally to the other two groups. For example, if 14 people in the first group are completed, the number 1 will be assigned to the second group and the number 2 to the third group, and henceforth the numbers 1, 3, and 4 for the second group and the numbers 2, 5 and 6 will be for the third one.
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
National Committee for Ethics in Biomedical Research
Street address
Ghods Town (West) - Between South Flamek and Zarafshan, Iran TV Street - Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th Floor
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2021-12-19, 1400/09/28
Ethics committee reference number
IR.SBU.REC.1400.177

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
Determining the effect of Brightonic training on mental fatigue in patients with MS
Timepoint
Pre-test and post-test
Method of measurement
Mental fatigue will be assessed by the MFIS Modified Fatigue Effect Questionnaire.

2

Description
Determining the effect of Brightonic training on inflammatory factors in patients with MS
Timepoint
Pre-test and post-test
Method of measurement
Inflammatory factors will be assessed by measuring the plasma levels of interleukin 17 and interleukin 4 and their ratios.

Secondary outcomes

1

Description
Determining the effect of Brightonic training on sleep quality in patients with MS
Timepoint
Pre-test and post-test
Method of measurement
By the Petersburg Sleep Quality Questionnaire

2

Description
Determining the effect of Brightonic training on quality of life in patients with MS
Timepoint
Pre-test and post-test
Method of measurement
By Vickery Quality of Life Questionnaire

Intervention groups

1

Description
Intervention group 1: Performing 8 weeks of aerobic-cognitive training called Brightonic training, which includes 2 sessions of approximately 40 minutes each week.
Category
N/A

2

Description
Intervention group 2: Perform 8 weeks of aerobic exercise called isotonic exercise, which includes 2 sessions of approximately 40 minutes each week.
Category
N/A

3

Description
Control group: 8 weeks without any activity and exercise.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
MS Clinic of Imam Hossein Hospital, Tehran
Full name of responsible person
Dr. Nahid Baladi Moghadam and Dr. Mehran Ghaffari
Street address
Tehran, Imam Hossein Square, at the beginning of Shahid Madani Street, Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2750
Fax
Email
info@ehmc.ir
Web page address
https://www.ehmc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of Physical Education and Sport Sciences, Shahid Beheshti University, Tehran
Full name of responsible person
Dr. Rana Fayaz Milani
Street address
Tehran, Evin, Shahid Shahriari Square
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1919
Fax
+98 21 2243 1607
Email
pr-office@sbu.ac.ir
Web page address
https://www.sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Physical Education and Sport Sciences, Shahid Beheshti University, Tehran
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
Faculty of Physical Education and Sport Sciences, Shahid Beheshti University, Tehran
Full name of responsible person
Sara Farajnia
Position
PhD tudent in sports physiology
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Tehran - Saadat Abad - Mohammad Ali Keshavarz Boulevard - East East Corner - No. 35 - Viva Yuka Tower - West West Unit
City
Tehran
Province
Tehran
Postal code
1997776452
Phone
+98 21 2641 6337
Email
sfarajnia2020@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Farajnia
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Saadat Abad District, Mohammad Ali Keshavarz Blvd., East 2nd Corner, No. 35, Viva Yuka Tower, West First Unit
City
Tehran
Province
Tehran
Postal code
1997776452
Phone
+98 21 2641 6337
Fax
Email
sfarajnia2020@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Farajnia
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Saadat Abad District, Mohammad Ali Keshavarz Blvd., East 2nd Corner, No. 35, Viva Yuka Tower, West First Unit
City
Tehran
Province
Tehran
Postal code
1997776452
Phone
+98 21 2641 6337
Fax
Email
sfarajnia2020@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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Plasma levels of interleukin-17 and interleukin-4 and mental fatigue Some of the data that will be related to the main consequences of the work will be shared after the people are not identified.
When the data will become available and for how long
Access period starts 1 year before the results are published
To whom data/document is available
Researchers related to MS
Under which criteria data/document could be used
To study in patients with multiple sclerosis
From where data/document is obtainable
1. Department of Sports Physiology, Faculty of Physical Education and Sport Sciences, Shahid Beheshti University, Tehran 2. MS Clinic of Imam Hossein Hospital, Tehran
What processes are involved for a request to access data/document
1. Request via email Dr. Rana Fayyaz Milani 2. Request via e-mail Dr. Mehran Ghaffari
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