<?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>IRCT20190408043203N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-30</date_registration>
      <primary_sponsor>Vice-Chancellor for Research of University of Guilan</primary_sponsor>
      <public_title>Effect of Aerobic Training and Calorie Restriction on Hormonal and Metabolic Factors Related to Fatty Liver in Postmenopausal Women with NAFLD</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Aerobic Training and Calorie Restriction on Hormonal and Metabolic Factors Related to Fatty Liver in Postmenopausal Women with NAFLD</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38708</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are randomly assigned with random number table in one of the three groups and will receive intervention of the same group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-Alcoholic Fatty Liver Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1st:  moderate intensity Aerobic Training (running on treadmill with 65% of HRmax), 4 days per week - 12 weeks. Intervention 2: Intervention group 2nd: Calorie Restriction (25 % reduction of daily energy requirement), 4 days per week - 12 weeks. Intervention 3: Intervention group 3rd: Aerobic Training with Calorie Restriction - 4 days per week - 12 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:
All data of measured variables can be shared without identifying subjects

When:
Starting at March 2020

To whom:
Researchers

Conditions:
Scientific use in improving and comparing with other researches is allowed

Where to obtain:
The applicant must contact the researcher's email address (Elham Akbarzadeh)
Email: akbarzadeh.elham@gmail.com

How to obtain:
Applicants must send the reasons for requesting the documentation to the researcher's e-mail address. The researcher, after examining the reasons and, if the reasons are sufficient, will send the documents for applicant up to 4 work days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht, Khalij Pars Highway(5th Kilometer of Ghazvin Road), University of Guilan, Faculty of Exercise Science</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۹۹۶۱۳۷۷۶</zip>
        <telephone>+98 13 3369 0485</telephone>
        <email>akbarzadeh.elham@gmail.com</email>
        <affiliation>The University of Guilan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Akbarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasht, Khalij Pars Highway(5th Kilometer of Ghazvin Road), University of Guilan, Faculty of Exercise Science</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۹۹۶۱۳۷۷۶</zip>
        <telephone>+98 13 3369 0485</telephone>
        <email>akbarzadeh.elham@gmail.com</email>
        <affiliation>The University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Overweight  Postmenopausal Women with NAFLD</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Weight Changing over 2 kg over the past 6 months
Smoking
Alcohol consumption more than 30 grams per day
Use of supplementary pills and special dietary
Cardiovascular disease And respiratory diseases
Orthopedic problems
Prohibition of participation in sports activities
Regular exercise in the past year (at least 3 days a week)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K75.81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonalcoholic steatohepatitis (NASH)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1st:  moderate intensity Aerobic Training (running on treadmill with 65% of HRmax), 4 days per week - 12 weeks</i_keyword>
      <i_keyword>Intervention group 2nd: Calorie Restriction (25 % reduction of daily energy requirement), 4 days per week - 12 weeks</i_keyword>
      <i_keyword>Intervention group 3rd: Aerobic Training with Calorie Restriction - 4 days per week - 12 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Estrogen Levels. Timepoint: Before and after intervention. Method of measurement: Blood Sample Analysis.</prim_outcome>
      <prim_outcome>Insulin Resistance Index. Timepoint: Before and after intervention. Method of measurement: Insulin Resistance Index Formula with Insulin and Glucose Levels.</prim_outcome>
      <prim_outcome>Hepatic Fat. Timepoint: Before and after intervention. Method of measurement: elastography.</prim_outcome>
      <prim_outcome>Glucose Levels. Timepoint: Before and after intervention. Method of measurement: Blood Sample Analysis.</prim_outcome>
      <prim_outcome>Insulin Levels. Timepoint: Before and after intervention. Method of measurement: Blood Sample Analysis.</prim_outcome>
      <prim_outcome>Liver Enzymes. Timepoint: Before and after intervention. Method of measurement: Blood Sample Analysis.</prim_outcome>
      <prim_outcome>Fetuin A Levels. Timepoint: Before and after intervention. Method of measurement: Blood Sample Analysis.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Before and after intervention. Method of measurement: Blood Sample Analysis.</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>Vice-Chancellor for Research of University of Guilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-09</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Rasht, Namjoo St, Shahid Siadati Avenue, in front of the 17th Shahrivar Hospital, vice chancellery for research and technology Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
