<?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>IRCT20161129031165N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-12</date_registration>
      <primary_sponsor>Lorestan university</primary_sponsor>
      <public_title>The Effect of Exercise on Depression, Anxiety, and Stress</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Eight Weeks of Aerobics Exercise on Depression, Anxiety, and Stress in Women with Subclinical Hypothyroidism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>41</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39333</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After referring to the Rasool Akram Hospital in Abdanan city, the subjects will be selected based on their availability and after obtaining consent, and using simple randomization method (Flip the coin) assigned into two groups: experimental group (eight weeks aerobic training) and control group (doing daily activities).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Subclinical Hypothyroidism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The experimental group will participate in an Aerobics exercise program for three sessions (60 min) per week for eight weeks. Both groups will take levothyroxine tablets. Intervention 2: Control group: Control subjects will not participate in any kind of activity regularly and will only take levothyroxine for 8 weeks.</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:
The only consequence of this is the sharing of data

When:
Start the access period after printing the results

To whom:
Researchers

Conditions:
-

Where to obtain:
-

How to obtain:
-

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Valiopour Dehnou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lorestan University</address>
        <city>Khorram Abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>44316-68151</zip>
        <telephone>+98 66 3312 0086</telephone>
        <email>valipour.v@lu.ac.ir</email>
        <affiliation>Lorestan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Valiopour Dehnou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lorestan University</address>
        <city>Khorram Abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>44316-68151</zip>
        <telephone>+98 66 3312 0086</telephone>
        <email>valipour.v@lu.ac.ir</email>
        <affiliation>Lorestan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age from 30 to 45 years
Consume at least 6 months of Levothyroxine regularly
Female gender</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>cardiovascular disease and diabetes
alcohol and tobacco use
Orthopedic problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Subclinical iodine-deficiency hypothyroidism</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The experimental group will participate in an Aerobics exercise program for three sessions (60 min) per week for eight weeks. Both groups will take levothyroxine tablets.</i_keyword>
      <i_keyword>Control group: Control subjects will not participate in any kind of activity regularly and will only take levothyroxine for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Depression, Anxiety and Stress Questionnaire with 21 items.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Depression, Anxiety and Stress Questionnaire with 21 items.</prim_outcome>
      <prim_outcome>Stress. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Depression, Anxiety and Stress Questionnaire with 21 items.</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>Lorestan university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-15</approval_date>
        <contact_name>Ethics Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Lorestan province, Khorramabad city, Lorestan university of medical sciences Khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
