<?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>IRCT20220809055643N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-16</date_registration>
      <primary_sponsor>Shahrekord University</primary_sponsor>
      <public_title>Effect of combined exercise training on subclinical hypothyroidism variables</public_title>
      <acronym></acronym>
      <scientific_title>Effect of a 12-week combined exercise training program on lipid peroxidation, total antioxidant capacity, high-sensitivity C-reactive protein, body composition, physical function, and lipid profile in women with subclinical hypothyroidism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65167</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: A new and safe training system, as well as exploring variables that have been less explored, Randomization description: After completing all the initial evaluations, the subjects will be divided into the training group and the control group using two block randomization in order to balance the number of samples allocated. Also, due to the importance of concealing the random allocation, a sealed envelope is used. It is intended to perform random blocking based on age and one of the body composition indicators such as body mass index or fat percentage.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Subclinical hypothyroidism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  receiving a resistance exercise program with an elastic band and performing an aerobic program on a treadmill or an exercise bike. Intervention 2: Intervention group:  Subjects in the intervention group receive two types of exercises for 12 weeks. At the beginning of each session, 10 minutes of warm-up exercises, then 5 minutes of stretching exercises - after that, 20 minutes of resistance exercises using an elastic band with an intensity of 60 to 75%, a maximum repetition in the range of 12 to 14 repetitions, and then aerobic exercises on a ergometer or Treadmill will be done with 40 to 60% Vo2max for 30 minutes, and at the end stretching movements will be done to cool down the body.</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:
After the relevant article is printed

When:
Access starts 3 months after results are published

To whom:
Everyone and public

Conditions:
Prevention and treatment

Where to obtain:
Internet

How to obtain:
search

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Javad Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.238, Lale Sharghi Blvd. Bazarche Ave, 2 Moshtaghe Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8818634141</zip>
        <telephone>0098-038- 32324401-07</telephone>
        <email>azamianakbar@yahoo.com</email>
        <affiliation>Shahrekord University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akbar Azamian Jazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord University, Rahbar Blvd</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8818634141</zip>
        <telephone>0098-038-32324401-07</telephone>
        <email>azamianakbar@yahoo.com</email>
        <affiliation>Shahrekord University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>TSH between 5 and 10 mu/l
No special disease and no medication
Same body mass index
No pregnant
no regular exercise training for at least six months before participating in this study
No smoking
No alcohol consumption
Not using food supplements containing zinc, magnesium and vitamin A during the last 3 months</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnosis of the attending physician regarding the need to withdraw from the study
Personal desire to withdraw from the study
Getting other diseases</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  receiving a resistance exercise program with an elastic band and performing an aerobic program on a treadmill or an exercise bike.</i_keyword>
      <i_keyword>Intervention group:  Subjects in the intervention group receive two types of exercises for 12 weeks. At the beginning of each session, 10 minutes of warm-up exercises, then 5 minutes of stretching exercises - after that, 20 minutes of resistance exercises using an elastic band with an intensity of 60 to 75%, a maximum repetition in the range of 12 to 14 repetitions, and then aerobic exercises on a ergometer or Treadmill will be done with 40 to 60% Vo2max for 30 minutes, and at the end stretching movements will be done to cool down the body.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lipid peroxidation. Timepoint: 24 hours before the beginning of the interventions - 48 hours after the end of the interventions. Method of measurement: Measurement of malondialdehyde through blood sample taken by valid laboratory kits.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: 24 hours before the beginning of the interventions - 48 hours after the end of the interventions. Method of measurement: Measurement of antioxidant capacity through blood samples taken by valid laboratory kits.</prim_outcome>
      <prim_outcome>C-reactive protein with high sensitivity. Timepoint: 24 hours before the beginning of the interventions - 48 hours after the end of the interventions. Method of measurement: Measurement of C-reactive protein level in blood sample by valid laboratory kits.</prim_outcome>
      <prim_outcome>Blood lipid profile. Timepoint: 24 hours before the beginning of the interventions - 48 hours after the end of the interventions. Method of measurement: Measuring the level of lipid profile in the blood sample by valid laboratory kits.</prim_outcome>
      <prim_outcome>Body fat percentage. Timepoint: 24 hours before the beginning of the interventions - 48 hours after the end of the interventions. Method of measurement: Measurement of the thickness of subcutaneous fat (triceps brachialis, Supraspinatus and thigh) using calipers and formula calculations.</prim_outcome>
      <prim_outcome>Waist to hip ratio. Timepoint: 24 hours before the beginning of the interventions - 48 hours after the end of the interventions. Method of measurement: Measure waist circumference at the narrowest point divided by hip circumference at the widest point.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: 24 hours before the beginning of the interventions - 48 hours after the end of the interventions. Method of measurement: Measure weight in kilograms by height in meters to the power of two.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lipid peroxidation. Timepoint: 48 hours after the last training session. Method of measurement: Malondialdehyde measurement through a blood sample taken by a valid laboratory kit.</sec_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: 48 hours after the last training session. Method of measurement: Measuring the antioxidant capacity of blood by valid laboratory kits.</sec_outcome>
      <sec_outcome>C-reactive protein with high sensitivity. Timepoint: 48 hours after the last training session. Method of measurement: Measurement of C-reactive protein level in blood by valid laboratory kits.</sec_outcome>
      <sec_outcome>Lipid profile. Timepoint: 48 hours after the last training session. Method of measurement: Measurement of lipid profile components in blood by valid laboratory kits.</sec_outcome>
      <sec_outcome>Body fat percentage. Timepoint: 48 hours after the last training session. Method of measurement: Measurement of the thickness of subcutaneous fat (triceps brachialis, Supraspinatus and thigh) using calipers and formula calculations.</sec_outcome>
      <sec_outcome>Waist to hip ratio. Timepoint: 48 hours after the last training session. Method of measurement: Waist circumference at the lowest point divided by hip circumference at the widest part.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: 48 hours after the last training session. Method of measurement: Weight in kilograms divided by height in meters to the power of two.</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>Payment of financial resources by the researcher</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-26</approval_date>
        <contact_name>Research Ethics Committee in Shahrekord University</contact_name>
        <contact_address>Shahrekord University, Blvd Rahbar, Shahrekord Shahre kord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
