<?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>IRCT20220324054348N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-09</date_registration>
      <primary_sponsor>The University of Hakim Sabzevari</primary_sponsor>
      <public_title>The effect of Pilates exercise on the treatment of multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks Home-Based and Outdoor Pilates Training on Neurofilament light chain, Kynurenine pathway, serum vitamin D, physical function and some psychological factors in women with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62634</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: Among the reasons for this study is the role of home-based exercise in preventing the risk of Covid 19 in sports venues, the benefits of Pilates training and its ability to perform and adjust its intensity at home, its low cost and popularity among these patients, and its impact on improving the condition. Functional and psychological of these patients and, most importantly, considering the role of sunlight in the absorption of vitamin D and its effect on disease severity and modulation of psychological factors, it is not yet clear whether exercise through the kynurenine pathway or through other mediators can affect the results. Whether it has a psychological effect or not (Lim et al., 2021). Therefore, according to studies conducted so far, no research has been observed on the effect of Pilates exercise at home and outdoors on the structural proteins of neurons and important molecular pathways in the progression of the disease and psychological and physical factors in patients with MS. Therefore, this study is the first study to compare the effect of 8 weeks of Pilates training at home and outdoors on NFL indices, kynurenine pathway (KYN, TRP, KA, QA), serum vitamin D, and some psychological factors (fatigue, depression, quality of life). And physical function (coordination, balance, abdominal muscle endurance, gait endurance, and upper and lower body muscle strength) of women with MS.</study_design>
      <phase>N/A</phase>
      <hc_freetext>multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Pilates Exercise Group Outdoors Intervention.15 people performed an exercise program for eight weeks (three sessions per week, each session one hour). The exercise consisted of three parts: warming up, the main body of the exercise, and cooling down. The subjects had to perform 7, 14, and 9 Pilates movements in each section, respectively. Intervention 2: Intervention group2: group. Pilates practice at home. 15 people performed an exercise program for eight weeks (three sessions per week, each session one hour). The exercise consisted of three parts: warming up, the main body of the exercise, and cooling down. The subjects had to perform 7, 14, and 9 Pilates movements in each section, respectively. Intervention 3: Control group: 14 people participated in the study for eight weeks and did 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>NO 612 Bargh street, Kheybar Alley</address>
        <city>Darab</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617976487</zip>
        <telephone>+98 51 4401 2763</telephone>
        <email>r.askari@hsu.ac.ir</email>
        <affiliation>The University Of Hakim Sabzevari</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faranak Balaghi Inaloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO 612 Bargh street, Kheybar Alley</address>
        <city>Darab</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617976487</zip>
        <telephone>+98 71 5352 4843</telephone>
        <email>faranakbalaghi70@gmail.com</email>
        <affiliation>The University of Hakim Sabzevari</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>at least two years of history
EDSS between 2 and 5
no smoking,
no regular exercise</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Muscle injuries
Severe relapse of the disease
disability to perform sports exercises
Lack of regular participation in the training protocol
Participate in a training program other than the research training protocol,
Pregnancy
relapse of MS in the last 12 weeks
Change in MS medication or steroid treatment in the last 12 weeks and period of practice
Lack of cooperation until the end of the research process</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 performed an exercise program for eight weeks (three sessions per week, each session one hour). The exercise consisted of three parts: warming up, the main body of the exercise, and cooling down. The subjects had to perform 7, 14, and 9 Pilates movements in each section, respectively.</i_keyword>
      <i_keyword>Intervention group2: group. Pilates practice at home. 15 people performed an exercise program for eight weeks (three sessions per week, each session one hour). The exercise consisted of three parts: warming up, the main body of the exercise, and cooling down. The subjects had to perform 7, 14, and 9 Pilates movements in each section, respectively.</i_keyword>
      <i_keyword>Control group: 14 people participated in the study for eight weeks and did not run any exercise program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood serum vitamin D status. Timepoint: 48 hours before and 48 hours after the intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA) by the Kit.</prim_outcome>
      <prim_outcome>The inflammatory status of axonal damage (Neurofilament light chain). Timepoint: 2 days before the intervention and 2 days after the intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA) by the Kit.</prim_outcome>
      <prim_outcome>Status of neuroprotective metabolites in the kynurenine pathway (kynurenine and kynurenic acid). Timepoint: 48 hours before and 48 hours after the intervention. Method of measurement: Liquid chromatography–mass spectrometry (LC–MS).</prim_outcome>
      <prim_outcome>Status of neurodegenerative metabolite in the kynurenine pathway (quinolinic acid). Timepoint: 48 hours before and 48 hours after the intervention. Method of measurement: Liquid chromatography–mass spectrometry (LC–MS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Assess fatigue status. Timepoint: Before the intervention and 2 days after the intervention. Method of measurement: By the Fatigue Severity Scale (FSS) Questionnaire.</sec_outcome>
      <sec_outcome>Evaluation of Quality of life. Timepoint: 48 hours before and 48 hours after the study. Method of measurement: By multiple sclerosis Quality of life-54 (MSQOL-54) Questionnaire.</sec_outcome>
      <sec_outcome>Evaluation of deppresion. Timepoint: 48 hours before and 48 hours after the study. Method of measurement: questionnaires Depression, Anxiety, Stress Scales (DASS-21).</sec_outcome>
      <sec_outcome>Physical function based on 6 minutes walking time. Timepoint: 48 hours before and 48 hours after the study. Method of measurement: Measurement of physical function (cardiorespiratory endurance) by 6-minute walking 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>The University of Hakim Sabzevari</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-16</approval_date>
        <contact_name>Ethics Committee in Research, Hakim Sabzevari University</contact_name>
        <contact_address>Tohid Town sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
