<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20191006045004N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-15</date_registration>
      <primary_sponsor>Shahrekord University</primary_sponsor>
      <public_title>Effect of exercise on immune and inflammatory factors in MS patients</public_title>
      <acronym></acronym>
      <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</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42785</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: Control group: The group will not receive any exercise activity.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
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:
Start the access period 3 months after printing results

To whom:
Only for researchers working in academic and academic institutions.

Conditions:
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

Where to obtain:
Saman Yousefi Saqqezi
Email: samanyousefi25@yahoo.com

How to obtain:
Confirmation of the relevant advisor and finally approved from vice chancellor for research and technology, University of Shahrekord

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saman Yousefi Saqqezi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Ansar Street, Farhang Blvd.</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8817976389</zip>
        <telephone>+98 38 3225 4315</telephone>
        <email>samanyousefi25@yahoo.com</email>
        <affiliation>Shahrekord University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saman Yousefi Saqqezi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Ansar Street, Farhang Blvd.</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8817976389</zip>
        <telephone>+98 38 3225 4315</telephone>
        <email>samanyousefi25@yahoo.com</email>
        <affiliation>Shahrekord University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <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</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>Control group: The group will not receive any exercise activity</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Expanded Disability Status Scale. Timepoint: Before and after 8 weeks of combined training (aerobic + resistance). Method of measurement: EDSS Test.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahrekord University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-30</approval_date>
        <contact_name>Ethics Committee in Research Sport Sciences Research Institute</contact_name>
        <contact_address>No,3, 5th St., Mir Emad St., Motahari Ave., Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
