<?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>IRCT20220316054315N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-29</date_registration>
      <primary_sponsor>Hakim Sabzevari University</primary_sponsor>
      <public_title>The effect   Pilates Training on  multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks Outdoor and Home-Based Pilates Training on sirtuin1, Chemokine CC ligand 20, serum vitamin D, physical function and some psychological factors in women with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62583</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with MS.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:  Pilates Exercise Group Outdoors Intervention.15 people will perform an exercise program for eight weeks (three sessions per hour). Intervention 2: Intervention group2: group. Pilates practice at home. 15 people will perform an exercise program for eight weeks (three sessions per hour). Intervention 3: Control group: 14 people will participate in the study for eight weeks and will not run any exercise program.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>dr roya askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Town, University Street</address>
        <city>sabzavar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617976487</zip>
        <telephone>+98 51 4401 2763</telephone>
        <email>vahdatpoor.114@gmail.com</email>
        <affiliation>the Hakim Sabzevari University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>halimeh vahdatpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Town, Hakim Sabzevari University</address>
        <city>sabzavar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617976487</zip>
        <telephone>+98 51 4401 2763</telephone>
        <email>hvahdatpoor.114@gmail.com</email>
        <affiliation>the Hakim Sabzevari University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria included no smoking,
no regular exercise
at least two years of history</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Muscle injuries,
inability to perform exercise
 severe recurrence of the disease
participation in a training program other than the training protocol of research
pregnancy
recurrence of MS in the last 12 weeks
change in MS medication or steroid treatment in 12 weeks Past and period of practice
non-cooperation until the end of the research process
severe recurrence of the disease</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>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1:  Pilates Exercise Group Outdoors Intervention.15 people will perform an exercise program for eight weeks (three sessions per hour).</i_keyword>
      <i_keyword>Intervention group2: group. Pilates practice at home. 15 people will perform an exercise program for eight weeks (three sessions per hour).</i_keyword>
      <i_keyword>Control group: 14 people will participate in the study for eight weeks and will not run any exercise program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical function based on 6 minutes walking time. Timepoint: Periods of this study before the intervention and 2 days after the intervention. Method of measurement: Measurement of physical function (cardiorespiratory endurance) by 6-minute walking test.</prim_outcome>
      <prim_outcome>Investigation of inflammatory status. Timepoint: Measurement of serum cysteine 1 and chemokine 20. Method of measurement: Before intervention and 2 days after intervention.</prim_outcome>
      <prim_outcome>Check serum vitamin D status. Timepoint: Before intervention and 2 days after intervention. Method of measurement: Examination of blood serum vitamin D by the kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Assess stress and anxiety. Timepoint: Before the intervention and 2 days after the intervention. Method of measurement: By means of the DASS-21 Stress-Anxiety Questionnaire.</sec_outcome>
      <sec_outcome>Evaluation of resilience. Timepoint: Before the intervention and 2 days after the intervention. Method of measurement: By Connor-Davidson Resilience Questionnaire.</sec_outcome>
      <sec_outcome>Evaluation of sleep quality. Timepoint: Before the intervention and 2 days after the intervention. Method of measurement: By Sleep Quality 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>This research work does not have a sponsor or sponsor.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-14</approval_date>
        <contact_name>Sabzevar Hakim University Code of Ethics Committee</contact_name>
        <contact_address>Tohid Town, University Street Sabzavar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
