<?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>IRCT20150531022498N24</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-25</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of exercise training on chronic heart failure patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of  concurrent aerobic- resistance training on aerobic power, heart structure and function, heart rate variables, galectin-3 and N-terminal pro-brain natriuretic peptide in patients with chronic heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31238</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple random, Among the candidates who are qualified, the lottery method is performed after a justification session and expressing the possible benefits and disadvantages.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Heart Failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Aerobic training and concurrent resistance for eight weeks and three days a week, 60 minutes a day that progressive aerobic exercise with 60 to 90 percent of maximum heart rate at rest and strength by 60 to 85% of one repetition maximum. Intervention 2: Control group: Without intervention.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The study was not completed</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>zahra mahmoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3336 4861</telephone>
        <email>fmahmoodi1390@Gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ramin Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3336 4861</telephone>
        <email>shabani_msn@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with chronic heart failure in NYHA II-III Classification with ejection fraction(EF) &gt; 20%</inclusion_criteria>
      <agemin>52 years</agemin>
      <agemax>78 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with NYHA IV class
Patients with acute myocarditis
Patients with disorder exercise (such as severe aortic stenosis, severe hypertrophic cardiomyopathy (HOCM), etc.)
Patients are not able to perform 6MWT ''. For example, osteoarthritis, knee surgery, cerebrovascular infarct , and so on
Patients with specific cognitive impairment
Patients with psychiatric and nervous disorders who are being treated with sedative medicines
Patients with orthopedic, verbal and auditory problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Congestive heart failure, Congestive heart disease Right ventricular failure (secondary to left heart failure)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Aerobic training and concurrent resistance for eight weeks and three days a week, 60 minutes a day that progressive aerobic exercise with 60 to 90 percent of maximum heart rate at rest and strength by 60 to 85% of one repetition maximum</i_keyword>
      <i_keyword>Control group: Without intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Galectin-3. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Serum level by ELISA method(n mol/ ml).</prim_outcome>
      <prim_outcome>N-terminal pro-brain natriuretic peptide. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Serum level by ELISA method(n mol/ ml).</prim_outcome>
      <prim_outcome>Aerobic Power. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Maximum heart rate,  6-Minute Walk Test(6MWT).</prim_outcome>
      <prim_outcome>Structure and function of heart. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Heart rate variables. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Maximum heart rate.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-10</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University Rasht Branch</contact_name>
        <contact_address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
