<?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>IRCT2017011821258N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-19</date_registration>
      <primary_sponsor>Islamic Azad University of Boroujerd</primary_sponsor>
      <public_title>Effects of exercise on nonalcoholic fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of six weeks combined aerobic and resistance exercise training on some liver function parameters in Middle-aged men with non-alcoholic fatty liver disease.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18671</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nonalcoholic fatty liver disease (NAFLD).</hc_freetext>
      <i_freetext>Intervention 1: The intervention group participants performed six weeks and three sessions per week combined of aerobic and resistance training that Including: 60-90 minutes aerobic exercise With an intensity of 45-75% of maximum heart rate (At first, with 45 percent of maximum heart rate that gradually increased up to 75 percent of maximum heart rate) on the bike and elliptical trainer, and resistance training that Includes: 3 sets with 8-12 repetition, with 50% of one repetition maximum (At first, with 50 percent of one repetition maximum that gradually increased up to 75 percent of one repetition maximum)  and bench press, squat, curl (to strengthen the both of upper and lower body), and knee extension. Intervention 2: The control group participants continued with their usual activities, which may have included leisure and sporting activities but did not include a progressive resistance and aerobic training program.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Ali Samavati Sharif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu Ali Sina University of Hamadan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3829 2614</telephone>
        <email>ali.samavati@gmail.com</email>
        <affiliation>Bu Ali Sina University of Hamadan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ali Samavati Sharif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu Ali Sina University of Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3829 2614</telephone>
        <email>ali.samavati@gmail.com</email>
        <affiliation>Bu Ali Sina University of Hamadan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1. non-alcoholic fatty liver disease; 2. males; 3. having the age range of 45-30 years old.&#13;
Exclusion criteria: &#13;
1. under the age of 30 years ; 2. age over 45 years old; 3. patients with cardiovascular disease; 4. patients with high blood pressure; 5. patients who have studied interoperability; 6. patients with musculoskeletal disorders; 7. people with Medical ban to participate in sports activities; 8. alcohol consumption.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonalcoholic fatty liver disease (NAFLD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group participants performed six weeks and three sessions per week combined of aerobic and resistance training that Including: 60-90 minutes aerobic exercise With an intensity of 45-75% of maximum heart rate (At first, with 45 percent of maximum heart rate that gradually increased up to 75 percent of maximum heart rate) on the bike and elliptical trainer, and resistance training that Includes: 3 sets with 8-12 repetition, with 50% of one repetition maximum (At first, with 50 percent of one repetition maximum that gradually increased up to 75 percent of one repetition maximum)  and bench press, squat, curl (to strengthen the both of upper and lower body), and knee extension.</i_keyword>
      <i_keyword>The control group participants continued with their usual activities, which may have included leisure and sporting activities but did not include a progressive resistance and aerobic training program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Alanine Aminotransferase Enzyme (ALT). Timepoint: Baseline and final (6th week). Method of measurement: Blood samples test.</prim_outcome>
      <prim_outcome>Blood Aspartate Aminotransferase Enzyme (AST). Timepoint: Baseline and final (6th week). Method of measurement: Blood samples test.</prim_outcome>
      <prim_outcome>Liver fats. Timepoint: Baseline and final (6th week). Method of measurement: Liver ultrasound.</prim_outcome>
      <prim_outcome>Body weight. Timepoint: Baseline and final (6th week). Method of measurement: Digital balance.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: Baseline and final (6th week). Method of measurement: Weight (kg) divided by square of height (m).</prim_outcome>
      <prim_outcome>Maximum oxygen uptake. Timepoint: Baseline and final (6th week). Method of measurement: Rockport Fitness Walking Test.</prim_outcome>
      <prim_outcome>Waist-to-hip ratio (WHR). Timepoint: Baseline and final (6th week). Method of measurement: Waist circumference divided by hip circumference.</prim_outcome>
      <prim_outcome>Body fat percent. Timepoint: baseline and final (6th week). Method of measurement: Measurement of skin fold thickness.</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>Islamic Azad University of Boroujerd</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-18</approval_date>
        <contact_name>Hamedan University of Medical Sciences and Health Services</contact_name>
        <contact_address>Hamedan University of Medical Sciences and Health Services Hamedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
