<?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>IRCT2012113011616N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-03</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of educational exercise intervention on heart failure</public_title>
      <acronym></acronym>
      <scientific_title>Surrvey of educational  exercise intervention efficiency based on social cognitive theory in patients empowerment diagnosed with heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-03-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11806</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Rehabilitation program for 8-week course of exercise (three 60-minute sessions per week). Frequency of steady state training is included 5-10  minutes sessions 3 times per week for more compromised patients; 20–30 minutes sessions 3 times per week  for patients with good functionalcapacity. Intensity of training sessionsis included initial phase that it is 40–50% peak VO2, increasing duration from 5–15 minutes and inimprovement phase that it is gradual increase to 60–80% peak VO2, increasing duration to 15–20 minutes (up to 30 minutes as secondary goal). Patient work out in interval training by cycling and treadmill. Patiets exercise in work phase of 30–120 seconds and recovery phase of 60–120 seconds at an intensity of 50% of maximum short term capacity (determined on exercise bike) by cycling. Heart failure patients work out with tredmill in work and recovery phases 60 seconds each. The cardiac rehabilitation is also included combination of nutritional counseling, medication follow-ups, stress management and depression counseling. Intervention 2: Intervention group: the intervention group are attended the weekly social cognitive theory-based educational sessions and face to face intervention during rehabilitation program. Content education covers self-management components, warning sign for heart failure, understanding risk for heart failure, what exercise you can do and how can you get your heart rate. Patient are encouraged  to take walking, jogging, biking,calisthenics on nonrehabilitation days, because some patients who develop exhaustion after training may need a day of rest between sessions, these recommendation are offerd by the specialist in sport medicine. The families are educated about their supportive role in patient exercise. Pamphlet, book, CD and other material about heart failure and exercise are provided for patients.</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 Rajati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department Of Health Education and Promotion, Isfahan University of Medical Science, Hezar Jarib Str</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1792 2652</telephone>
        <email>f_rajati@hlth.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Firoozeh Mostafavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Education and Promotion, School of Public, Isfahan University of Medical Science, Hezar Jarib Str</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1792 2671</telephone>
        <email>mostafavi@hlth.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
(a) age 21 years or greater.&#13;
(b) optimum medical therapy with no changes in medications within the past 30 days.&#13;
(c) New York Heart Association (NYHA) Class II and Class III.&#13;
(d) resting left ventricular ejection fraction &lt; 40%.&#13;
(e)able to speak and read Persian.&#13;
(f)Willingness to participate in the study.&#13;
 Exclucion criteria:&#13;
(a) clinical evidence of decompensated HF.&#13;
(b) unstable angina pectoris.&#13;
(c) orthopedic or neuromuscular disorders preventing participation in exercise and strength/resistance training.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>69 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Heart failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Rehabilitation program for 8-week course of exercise (three 60-minute sessions per week). Frequency of steady state training is included 5-10  minutes sessions 3 times per week for more compromised patients; 20–30 minutes sessions 3 times per week  for patients with good functionalcapacity. Intensity of training sessionsis included initial phase that it is 40–50% peak VO2, increasing duration from 5–15 minutes and inimprovement phase that it is gradual increase to 60–80% peak VO2, increasing duration to 15–20 minutes (up to 30 minutes as secondary goal). Patient work out in interval training by cycling and treadmill. Patiets exercise in work phase of 30–120 seconds and recovery phase of 60–120 seconds at an intensity of 50% of maximum short term capacity (determined on exercise bike) by cycling. Heart failure patients work out with tredmill in work and recovery phases 60 seconds each. The cardiac rehabilitation is also included combination of nutritional counseling, medication follow-ups, stress management and depression counseling.</i_keyword>
      <i_keyword>Intervention group: the intervention group are attended the weekly social cognitive theory-based educational sessions and face to face intervention during rehabilitation program. Content education covers self-management components, warning sign for heart failure, understanding risk for heart failure, what exercise you can do and how can you get your heart rate. Patient are encouraged  to take walking, jogging, biking,calisthenics on nonrehabilitation days, because some patients who develop exhaustion after training may need a day of rest between sessions, these recommendation are offerd by the specialist in sport medicine. The families are educated about their supportive role in patient exercise. Pamphlet, book, CD and other material about heart failure and exercise are provided for patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical activity. Timepoint: Befor, after, one month, three months after intervention. Method of measurement: Inrternational Physical Activity Questionnaire (IPAQ).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Befor, after, one month, three months after intervention. Method of measurement: Minnesota Living with Heart Failure Questionnaire (MLHF).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self-efficacy. Timepoint: befor, after, one, and three months. Method of measurement: Cardiac Exercise Self-efficacy Questionnaire (CESE).</sec_outcome>
      <sec_outcome>Self-regulation. Timepoint: Befor, after, one, and three months. Method of measurement: Exercise self-regulation questionnaire.</sec_outcome>
      <sec_outcome>Outcome expectation. Timepoint: Befor, after, one, and three months. Method of measurement: Exercise outcome expectation questionnaire.</sec_outcome>
      <sec_outcome>Social support. Timepoint: Befor, after, one, and three months. Method of measurement: Exercise social support questionnaire.</sec_outcome>
      <sec_outcome>Ejection fraction. Timepoint: Befor and after intervention. Method of measurement: Echocardiography.</sec_outcome>
      <sec_outcome>Exercise tolerance. Timepoint: Befor and after intervention. Method of measurement: Exercise tolerance test per METs.</sec_outcome>
      <sec_outcome>Systolic blood perssure at rest. Timepoint: Befor, after, one, and three months. Method of measurement: Per mm Hg using a mercury barometer.</sec_outcome>
      <sec_outcome>Diastolic blood pressure at rest. Timepoint: Befor and after intervention. Method of measurement: Per mm Hg using a mercury barometer.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: befor, after, one, and three months. Method of measurement: Pluse rate in beats per minute.</sec_outcome>
      <sec_outcome>Knowledge about for Heart Failure. Timepoint: Befor, after, one, and three months. Method of measurement: The Patient Knowledge Questionnaire for Heart Failure Patients.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-03-05</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Medical university of Isfahan, Hezar jarib St. Isfahan, Iran Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
