<?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>IRCT20230819059185N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-24</date_registration>
      <primary_sponsor>Faculty of Sports Sciences and Physical Education, University of Isfahan</primary_sponsor>
      <public_title>The effect of aquatic exercise in water on thyroid hormone</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of aquatic exercise on body composition, blood lipids and thyroid hormone levels in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72283</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization will be in the form of six-block randomization. The current research will be conducted as a clinical trial. Pregnant women will be randomly assigned to the intervention and control groups using blocks of six. The research environment will be Isfahan University.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Thyroid hormone, blood lipid levels, body composition.</hc_freetext>
      <i_freetext>The number of people in the intervention group is 15 people. The intervention group starts training from 20 to 34 weeks of pregnancy. People in the intervention group during pregnancy perform water sports for 8 weeks, 3 sessions a week and each session is 40 minutes with moderate intensity in the indoor swimming pool of Isfahan University under the supervision of a trainer and a midwife. The time of each session includes: impact position, warm-up phase (5 minutes), aerobic phase (20 minutes), strength phase (10 minutes) and the last final phase of returning to the relaxation state (5 minutes) in which relaxation techniques and Muscles are stretched..</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Kargarfard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mehdi Kargarfard Professor, University of Isfahan Faculty of Sport Sciences Department of Exercise Physiology Hezar Jerib Street, P.O. Box 81746-7344 Ph: +98 31 37934282 Fax: +98 31 36687572 Email: m.kargarfard@spr.ui.ac.ir</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-7344</zip>
        <telephone>+98 31 3668 7572</telephone>
        <email>m.kargarfard@spr.ac.ir</email>
        <affiliation>The university of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Kargarfad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mehdi Kargarfard Professor, University of Isfahan Faculty of Sport Sciences Department of Exercise Physiology Hezar Jerib Street, P.O. Box 81746-7344 Ph: +98 31 37934282 Fax: +98 31 36687572 Email: m.kargarfard@spr.ui.ac.ir</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۴۱</zip>
        <telephone>+98 31 3668 7572</telephone>
        <email>m.kargarfard@spr.ui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>20-34 weeks of pregnancy
Consent to participate in the study</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diseases such as: blood pressure, heart problems, absence of more than 2 sessions in exercise programs
Dissatisfaction with participating in the research</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>The number of people in the intervention group is 15 people. The intervention group starts training from 20 to 34 weeks of pregnancy. People in the intervention group during pregnancy perform water sports for 8 weeks, 3 sessions a week and each session is 40 minutes with moderate intensity in the indoor swimming pool of Isfahan University under the supervision of a trainer and a midwife. The time of each session includes: impact position, warm-up phase (5 minutes), aerobic phase (20 minutes), strength phase (10 minutes) and the last final phase of returning to the relaxation state (5 minutes) in which relaxation techniques and Muscles are stretched.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body composition. Timepoint: Before the start of the intervention and 8 weeks after the intervention. Method of measurement: Body composition analysis device.</prim_outcome>
      <prim_outcome>Blood lipid levels. Timepoint: Before the start of the intervention and 8 weeks after the intervention. Method of measurement: Serum measurement.</prim_outcome>
      <prim_outcome>Thyroid hormone. Timepoint: Before the start of the intervention and 8 weeks after the intervention. Method of measurement: Serum measurement.</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>Faculty of Sports Sciences and Physical Education, University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-14</approval_date>
        <contact_name>Ethical Committee of Isfahan University</contact_name>
        <contact_address>University of Isfahan, Azadi Square Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
