<?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>IRCT20150531022498N34</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of combined training on breast cancer survivors</public_title>
      <acronym></acronym>
      <scientific_title>The effect of combined yoga and pilates training on sexual hormones, leptin, cortisol, glucose homeostasis and tumor markers on breast cancer survivors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49108</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The present study is a randomized controlled trial that thirty breast cancer survivors were selected as participants in the research process. After the necessary investigations and based on the information of the completed questionnaires, the subjects were divided into two groups of 15 people using a lottery by simple random method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis (MS).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  12 weeks of combined yoga and pilates training, three sessions per week, 75 minutes each session. Exercise training program consists of 10 minutes warming up, 30 minutes pilates training, 30 minutes yoga training and 5 minutes cooling down. Intervention 2: Control group: 12 weeks. routine daily activities.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No decision has been made yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samane Ebrahimpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4153911900</zip>
        <telephone>+98 13 4466 5179</telephone>
        <email>s99.ebrahimpour@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramin Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lakan St., Poltaleshan Blv. , Rasht, Gilan, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 2153</telephone>
        <email>shabani_msn@yahoo.com</email>
        <affiliation>Islamic Azad University, Rasht Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to perform exercise training with oncologist approval
underwent partial mastectomy
termination of chemotherapy
age between 35-50</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>More than three consecutive sessions or four intermittent sessions absence from the training
injury during training</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>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  12 weeks of combined yoga and pilates training, three sessions per week, 75 minutes each session. Exercise training program consists of 10 minutes warming up, 30 minutes pilates training, 30 minutes yoga training and 5 minutes cooling down</i_keyword>
      <i_keyword>Control group: 12 weeks. routine daily activities</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting Blood Sugar. Timepoint: before and after the end of intervention. Method of measurement: Serum levels using Enzymatic method.</prim_outcome>
      <prim_outcome>CA 15-3 tumor marker. Timepoint: before and after the end of intervention. Method of measurement: Serum levels using Eliza method.</prim_outcome>
      <prim_outcome>CA 125 tumor marker. Timepoint: before and after the end of intervention. Method of measurement: Serum levels using Eliza method.</prim_outcome>
      <prim_outcome>CEA tumor marker. Timepoint: before and after the end of intervention. Method of measurement: Serum levels using Eliza method.</prim_outcome>
      <prim_outcome>Cortisol hormone. Timepoint: before and after the end of intervention. Method of measurement: Serum levels using Eliza method.</prim_outcome>
      <prim_outcome>Estrogen Hormone. Timepoint: before and after the end of intervention. Method of measurement: Serum levels using Eliza method.</prim_outcome>
      <prim_outcome>Testosterone Hormone. Timepoint: before and after the end of intervention. Method of measurement: Serum levels using Eliza method.</prim_outcome>
      <prim_outcome>SHBG. Timepoint: before and after the end of intervention. Method of measurement: Serum levels using Eliza method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>HbA1C. Timepoint: Before and after the end of interventions. Method of measurement: Serum levels using Enzymatic method.</sec_outcome>
      <sec_outcome>Insulin hormone. Timepoint: Before and after the end of interventions. Method of measurement: Serum levels using Eliza method.</sec_outcome>
      <sec_outcome>Leptin hormon. Timepoint: Before and after the end of interventions. Method of measurement: Serum levels using Eliza method.</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>En Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-09</approval_date>
        <contact_name>Ethics Committee of Azad University, Lahijan Branch</contact_name>
        <contact_address>Shaghayegh Street, East Kashef Street, Lahijan City Lahijan Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
