<?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>IRCT201607236909N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-21</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention on lifestyle and clinical outcomes of patients with myocardial infarction</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational intervention, based on Pender's health promotion model on lifestyle and clinical outcomes of patients with myocardial infarction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-07-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7343</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>Myocardial Infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: eight training sessions lasting 45 minutes, twice a week, including: two sessions about the nature of cardiovascular disease, risk factors and treatment options, one sessions about medication, two sessions on healthy nutrition, one session on mental health, relaxation and rest, exercise and consultation, one session about the types of allowed exercise activities, frequency and time of useful exercise, how to control the pulse rate and allowed exercise intensity. Intervention 2: Control group: routine training (education about medications, nutrition and authorized activity).</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>Fatemeh Mohammadipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 31, Shahid Chaghorvand Alley, Dehkhoda Street, Enghelab Avenue, Khorram Abad, Lorestan</address>
        <city>Khorram Abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819836568</zip>
        <telephone>+98 66 3312 0195</telephone>
        <email>mohammadipourf@gmail.com</email>
        <affiliation>Lorestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Mohammadipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 31, Shahid Chaghorvand Alley, Dehkhoda Street, Enghelab Avenue, Khorram Abad, Lorestan</address>
        <city>Khorram Abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6819836568</zip>
        <telephone>+98 66 3312 0195</telephone>
        <email>mohammadipourf@gmail.com</email>
        <affiliation>Lorestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients who have no history of  previous myocardial infarction, with the age between 30 and 60 years, at least an elementary school education and the ejection fraction above 40 percent  (according to doctor's approval);  &#13;
Exclusion criteria: participation in rehabilitation programs in the control group and failure to participate in training sessions in the intervention group</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>121</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute myocardial infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: eight training sessions lasting 45 minutes, twice a week, including: two sessions about the nature of cardiovascular disease, risk factors and treatment options, one sessions about medication, two sessions on healthy nutrition, one session on mental health, relaxation and rest, exercise and consultation, one session about the types of allowed exercise activities, frequency and time of useful exercise, how to control the pulse rate and allowed exercise intensity</i_keyword>
      <i_keyword>Control group: routine training (education about medications, nutrition and authorized activity)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lifestyle. Timepoint: Befor and three months after intervention. Method of measurement: Health Promotion Lifestyle Profile (HPLP).</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Befor and three months after intervention. Method of measurement: Blood sample by auto analyzer BT3000.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Befor and three months after intervention. Method of measurement: Measuring arterial blood pressure by mercury sphygmomanometer.</prim_outcome>
      <prim_outcome>Ejection fraction. Timepoint: Befor and three months after intervention. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Fasting blood level of glucose. Timepoint: Befor and three months after intervention. Method of measurement: Measuring blood glucose by glucometer before breakfast.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cardiac knowledge. Timepoint: Befor and three months after the end of  intervention. Method of measurement: Cardiac knowledge questionnaire.</sec_outcome>
      <sec_outcome>Perceive benefits to behavior. Timepoint: Befor and three months after the end of  intervention. Method of measurement: Perceive Benefits to Behavior (PBB) questionnaire.</sec_outcome>
      <sec_outcome>Perceive barrier to behavior. Timepoint: Befor and three months after the end of  intervention. Method of measurement: Perceive Barrier to Behavior (PBB) questionnaire.</sec_outcome>
      <sec_outcome>Perceived self-efficacy. Timepoint: Befor and three months after the end of  intervention. Method of measurement: Perceived Self-Efficacy questionnaire.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-07-11</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research and technology, Gonabad University of Medical Sciences, next to the Asian Road, Gonabad, Razavi Khorasan Gonabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
