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The effect of eight weeks of combined training on the expression of some anti-antimicrobial and micro-RNAS related to immune, TLR-4 and TLR-2 in patients with multiple sclerosis

Protocol summary

Study aim
The effect of eight weeks of combined aerobic and resistance training on peptides expression, LL-37, beta-2nd human-2-, indices, TLR-2, TLR-4 and MicroRNA 155, 326, 23b, 21 and 146a in MS patients.
Design
his quasi-experimental study with pretest-posttest with experimental and control groups was used. After selecting 24 people, according to their inclusion criteria, random allocation will be divided into two groups of experimental and control.
Settings and conduct
The study population consisted of 90 of MS patient in Shahrekord, which 24 of them will be selected based on inclusion criteria. Then they will be randomly divided into two groups of experimental (n = 12) and control (n = 12). The study place will be conducted in Pars shahrekord Sports medicine.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmed diagnosis of relapsing and remitting MS; An Expanded Disability Status Scale (EDSS) score of 1 to 4; No history of any medical condition, that would preclude participation in the exercise program; Ability to participate in exercise; No participants in regular exercise in the last 6 months; The age range of 20-40. Non Inclusion criteria: Comorbidities that prevent participation (cardiovascular disease, metabolic disease, ets); Corticosteroid treatment; Body injury that effective cannot participate in the exercise program; Pregnancy.
Intervention groups
Experimental group: Combined Training (aerobic + resistance) for 8 weeks, 4 sessions with mild to moderate intensity will consist of 3 sessions of aerobic training and one session of resistance training. Control group: This group will not receive any intervention.
Main outcome variables
Relative expression LL-37; hDB-2; TLR-4; TLR-2 and microRNAs 155; 326; 21; 23b;146a

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191006045004N1
Registration date: 2019-11-15, 1398/08/24
Registration timing: retrospective

Last update: 2019-11-15, 1398/08/24
Update count: 0
Registration date
2019-11-15, 1398/08/24
Registrant information
Name
Saman Yousefi saqqezi
Name of organization / entity
Shahrekord University
Country
Iran (Islamic Republic of)
Phone
+98 38 3225 4315
Email address
samanyousefi25@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-21, 1398/03/31
Expected recruitment end date
2019-06-30, 1398/04/09
Actual recruitment start date
2019-06-30, 1398/04/09
Actual recruitment end date
2019-07-10, 1398/04/19
Trial completion date
2019-09-12, 1398/06/21
Scientific title
The effect of eight weeks of combined training on the expression of some anti-antimicrobial and micro-RNAS related to immune, TLR-4 and TLR-2 in patients with multiple sclerosis
Public title
Effect of exercise on immune and inflammatory factors in MS patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of definite relapsing and remitting MS (RRMS) An Expanded Disability Status Scale (EDSS) Score of 1 to 4 No history of any medical condition, that would preclude participation in the exercise program Ability to participate in exercise No Participants in regular exercise in the last 6 months The age range of 20 - 40 years
Exclusion criteria:
Comorbidities that prevent participation (cardiovascular disease: metabolic disease: etc.) Corticosteroid treatment Body injury that they effectively cannot participate in the exercise program Pregnancy
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Actual sample size reached: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be selected based on the criteria for entering the study as well as other necessary examinations. Than, the subjects will be randomly assigned (simple lottery) to the experimental and control groups. The simple lottery method in this study is done first; the names of all the people in accordance with the inclusion criteria; without observing the specific order on the paper pieces and placed inside the box (A total; 24 of them will select).Then mix the paper and the first 12 numbers whose names came out of the box in the experimental group and the next 12 people will be placed in the control group.
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 in Research Sport Sciences Research Institute
Street address
No,3, 5th St., Mir Emad St., Motahari Ave., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-06-30, 1398/04/09
Ethics committee reference number
IR.SSRC.REC.1398.071

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
The expression rate of anti-antimicrobial peptides hBD-2 and LL-37
Timepoint
Before and after 8 weeks of combined training (aerobic + resistance)
Method of measurement
Measurement kits for measuring the hBD-2 and LL-37 variables with methods Real Time-PCR

2

Description
Expression rate of micro-RNAS 155; 326; 23b; 146a; 21
Timepoint
Before and after 8 weeks of combined training (aerobic + resistance)
Method of measurement
Measuring kits for measuring the expression of micro-RNAS 155; 326; 23b; 146a; 21 by method Real Time -PCR

3

Description
Expression rate of TLR-4; TLR-2
Timepoint
Before and after 8 weeks of combined training (aerobic + resistance)
Method of measurement
Measurement kits for measuring the expression of TLR-4 and TLR-2 with Real Time-PCR method

Secondary outcomes

1

Description
Expanded Disability Status Scale
Timepoint
Before and after 8 weeks of combined training (aerobic + resistance)
Method of measurement
EDSS Test

Intervention groups

1

Description
Intervention group: Exercise training Protocol In this study, 32 training sessions, which included a total of 8 weeks of training and 4 sessions of training each week. 3 sessions will be aerobic training (bicycle and treadmill) and one session of resistance training. Cardio workouts are performed on Saturday, Sunday and Monday, and the Resistance training program is performed on Wednesday every week.
Category
Lifestyle

2

Description
Control group: The group will not receive any exercise activity
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Association of MS patients in Chaharmahal and Bakhtiari province
Full name of responsible person
Saman Yousefi Saqqezi
Street address
5th Street, Moharram 12 St., Basij Sq,Ms Forum.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816786574
Phone
+98 38 3225 4700
Email
samanyousefi25@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University
Full name of responsible person
Mohsen Mobini Dehkordi
Street address
ShahrKord University, Rahbar Boulevard, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 38 3232 4435
Email
mmobinid@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Saman Yousefi Saqqezi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 1, Ansar Street, Farhang Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817976389
Phone
+98 38 3225 4315
Email
samanyousefi25@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Saman Yousefi Saqqezi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 1, Ansar Street, Farhang Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817976389
Phone
+98 38 3225 4315
Email
samanyousefi25@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Saman Yousefi Saqqezi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 1, Ansar Street, Farhang Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817976389
Phone
+98 38 3225 4315
Email
samanyousefi25@yahoo.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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In this section, part of anthropometric information (height, weight and BMI), and information about the main outcomes of the study are shared after non-identifying people to print to a reputable magazine.
When the data will become available and for how long
Start the access period 3 months after printing results
To whom data/document is available
Only for researchers working in academic and academic institutions.
Under which criteria data/document could be used
1-If needed, and as a non-personally identifiable data, only the journals that the article will be sent to the printing. 2. Physicians in this study
From where data/document is obtainable
Saman Yousefi Saqqezi Email: samanyousefi25@yahoo.com
What processes are involved for a request to access data/document
Confirmation of the relevant advisor and finally approved from vice chancellor for research and technology, University of Shahrekord
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