<?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>IRCT20231222060493N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-10</date_registration>
      <primary_sponsor>Razi University of Kermanshah</primary_sponsor>
      <public_title>The effect of twelve weeks of light aerobic exercise on cognitive and motor performances in women with non-severe Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of twelve weeks of light aerobic exercise on cognitive and motor performances in women with non-severe Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75372</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: After completing all the pre-tests, the experimental group will be affected by the intervention of light and sub-maximal aerobic exercise program for twenty-four sessions in twelve weeks. The exercises will be two sessions per week, with a duration of one hour in each session, and each training session includes warming up, related exercises, and cooling down. It will be done at the end of the post-exams..</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:
All data can be shared after de-identifying the subjects.

When:
Six months after the results are published

To whom:
All people if they submit an official request

Conditions:
Requesting access to data for any purpose is permitted

Where to obtain:
If you need to receive documents, contact Marzieh Mehdiabadi, a master's student at Razi University, via email at the following email address.mmehdiabady2@gmail.com

How to obtain:
In case of submitting an official request, announcing the relevant reasons and mentioning the full details, the data will be announced via email after 72 hours.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Mehdi Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sports Sciences . Razi University . Taq Bostan . University St . Kermanshah . Iran</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3836 2077</telephone>
        <email>mmehdiabady2@gmail.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>marzieh mehdiabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of sports . Razy University . University St . Taq Bostan . Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414971</zip>
        <telephone>+98 83 3845 8428</telephone>
        <email>mmehdiabady2@gmail.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age range of eighteen to forty years• The gender of the subjects is female.Physical disability score of non-severe MS patients based on EDSS scale up to 5.5 (30-11)• Not having underlying diseases such as chronic heart diseases, arthritis or cognitive disorders• Not taking any medicine other than the medicine needed to treat MS• Not engaging in any sports and physical therapy activities at the same time as conducting this research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>• Any dissatisfaction or problem caused by the exercises• Two sessions of continuous absence or three sessions of intermittent absence of the subject• Any injury caused to the subject due to exercises• The option to leave the test at any time, by the examinee• Criteria for not entering the research• The presence of any underlying disease, including epilepsy and...• Taking any specific medication other than MS related medications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: After completing all the pre-tests, the experimental group will be affected by the intervention of light and sub-maximal aerobic exercise program for twenty-four sessions in twelve weeks. The exercises will be two sessions per week, with a duration of one hour in each session, and each training session includes warming up, related exercises, and cooling down. It will be done at the end of the post-exams.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in static equilibrium. Timepoint: Static balance is measured before interventional exercises, and this factor will be measured again after twelve weeks of interventional exercises. Method of measurement: by STROK static balance test.</prim_outcome>
      <prim_outcome>A change in dynamic equilibrium. Timepoint: Dynamic balance is measured before interventional exercises, and this factor will be measured again after twelve weeks of interventional exercises. Method of measurement: Y balance meter device.</prim_outcome>
      <prim_outcome>Change in flexibility. Timepoint: Flexibility is measured before interventional exercises, and this factor will be measured again after twelve weeks of interventional exercises. Method of measurement: Wells flexibility test.</prim_outcome>
      <prim_outcome>Change in reaction time. Timepoint: Before starting the intervention exercises, the reaction time is measured and after applying the intervention exercises for twelve weeks, this factor will be measured again. Method of measurement: Reaction time device from Lafayette company number 6305.</prim_outcome>
      <prim_outcome>Changes in bimanual coordination. Timepoint: Bimanual coordination is measured before interventional exercises, and this factor will be measured again after twelve weeks of interventional exercises. Method of measurement: Model 32532 two-handed continuous coordination device made by Lafayette Instrument Company.</prim_outcome>
      <prim_outcome>Change in memory. Timepoint: Memory is measured before interventional exercises, and this factor will be measured again after twelve weeks of interventional exercises. Method of measurement: En-back memory evaluation software.</prim_outcome>
      <prim_outcome>Change in fatigue. Timepoint: Before starting the interventional exercises, the level of fatigue is measured by the FSS fatigue questionnaire, and after twelve weeks of interventional exercises, this factor will be measured again. Method of measurement: FSS fatigue scale questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Razi University of Kermanshah</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-29</approval_date>
        <contact_name>Ethics Committee ofRazi University</contact_name>
        <contact_address>Kermanshah . Taq Bostan . University St . Razy University . Deputy Research Area Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
