<?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>IRCT20230618058515N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-04</date_registration>
      <primary_sponsor>Research Institute of Neuroscience, Faculty of Medical Sciences, Tehran</primary_sponsor>
      <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.</public_title>
      <acronym></acronym>
      <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.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70773</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</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:
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:
It is expected that data related to this research will be available from February 1402.

To whom:
All researchers in the field of clinical sports physiology and specialist doctors can access these data after the publication of articles from the project.

Conditions:
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.

Where to obtain:
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).

How to obtain:
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.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Torab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Kamali St., Shahid Naqibi Alley, No. 4, Unit 2</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1331777463</zip>
        <telephone>+98 41 3525 4804</telephone>
        <email>mohammad.torab@ut.ac.ir</email>
        <affiliation>Tehran university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Torab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Kamali St., Shahid Naqibi Alley, No. 4, Unit 2</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1331777463</zip>
        <telephone>+98 41 3525 4804</telephone>
        <email>mohammad.torab@ut.ac.ir</email>
        <affiliation>Tehran university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Worsening of the patient's condition
Inability to complete the exercise protocol
The beginning of the relapse period</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>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.</sec_outcome>
      <sec_outcome>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.</sec_outcome>
      <sec_outcome>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.</sec_outcome>
      <sec_outcome>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.</sec_outcome>
      <sec_outcome>EDSS. Timepoint: Before starting the training program and after its termination. Method of measurement: by a neurologist.</sec_outcome>
      <sec_outcome>Time to get tired. Timepoint: Before starting the training program and after its termination. Method of measurement: 6 minute walk 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>Sinai Hospital MS Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-11</approval_date>
        <contact_name>Ethics Committee of Neuroscience Research Institute &lt;&lt;Neural Rehabilitation&gt;&gt;</contact_name>
        <contact_address>No. 2-4th West Dead End-Shahid Naqeibi Alley-Kamali St.-Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
