<?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>IRCT20211214053407N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-28</date_registration>
      <primary_sponsor>Faculty of Physical Education and Sport Sciences, Shahid Beheshti University, Tehran</primary_sponsor>
      <public_title>The effect of exercise on fatigue in MS</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Aerobic-cognitive Combined Training on Inflammatory factors and Mental fatigue in Multiple Sclerosis Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60731</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Performing 8 weeks of aerobic-cognitive training called Brightonic training, which includes 2 sessions of approximately 40 minutes each week. Intervention 2: Intervention group 2: Perform 8 weeks of aerobic exercise called isotonic exercise, which includes 2 sessions of approximately 40 minutes each week. Intervention 3: Control group: 8 weeks without any activity and exercise.</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:
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:
Access period starts 1 year before the results are published

To whom:
Researchers related to MS

Conditions:
To study in patients with multiple sclerosis

Where to obtain:
1. Department of Sports Physiology, Faculty of Physical Education and Sport Sciences, Shahid Beheshti University, Tehran
2. MS Clinic of Imam Hossein Hospital, Tehran

How to obtain:
1. Request via email Dr. Rana Fayyaz Milani
2. Request via e-mail Dr. Mehran Ghaffari

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Farajnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Saadat Abad - Mohammad Ali Keshavarz Boulevard - East East Corner - No. 35 - Viva Yuka Tower - West West Unit</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1997776452</zip>
        <telephone>+98 21 2641 6337</telephone>
        <email>sfarajnia2020@gmail.com</email>
        <affiliation>Faculty of Physical Education and Sport Sciences, Shahid Beheshti University, Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Farajnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Saadat Abad District, Mohammad Ali Keshavarz Blvd., East 2nd Corner, No. 35, Viva Yuka Tower, West First Unit</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1997776452</zip>
        <telephone>+98 21 2641 6337</telephone>
        <email>sfarajnia2020@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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).</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <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</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>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Performing 8 weeks of aerobic-cognitive training called Brightonic training, which includes 2 sessions of approximately 40 minutes each week.</i_keyword>
      <i_keyword>Intervention group 2: Perform 8 weeks of aerobic exercise called isotonic exercise, which includes 2 sessions of approximately 40 minutes each week.</i_keyword>
      <i_keyword>Control group: 8 weeks without any activity and exercise.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>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.</sec_outcome>
      <sec_outcome>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.</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>Faculty of Physical Education and Sport Sciences, Shahid Beheshti University, Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-19</approval_date>
        <contact_name>National Committee for Ethics in Biomedical Research</contact_name>
        <contact_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 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
