<?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>IRCT20200113046119N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-11</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Investigation of the effect of exercise training on clinical status in infarction cardiac patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two different high-intensity interval training on clinical status improvement after coronary artery bypass grafting in cardiac patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45159</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization is used in the current study. The randomization unit is also considered individual. The random number table is also used as a randomization tool, Blinding description: This study is double-blinded that the subjects, clinical caregivers, researchers, outcome evaluators, and data analyzers are unaware of the allocation of study groups. Of course, The overall introduction of the study groups has been completely provided to the participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: High-intensity interval training Group with Short Activity Interventions: This group will perform high-intensity interval training exercises with 15-second intervals on the treadmill for 12 weeks and 24 training sessions. Indeed, there will be two training sessions in a week. The group's training program involves 15-second activity intervals with the intensity of 100% maximal aerobic power, with 15-second passive recovery among them. Each training session continues for 35 minutes. Intervention 2: Control group: This group will participate in the routine rehabilitation program of the Hamadan Farshchian Hospital for 12 weeks and 24 training sessions. Indeed, there will be two training sessions in a week. Each training session continues for 35 minutes. The group's training program involves aerobic continuous moderate-intensity training on the treadmill. Intervention 3: Second intervention group: High-intensity interval training Group with intermediate Activity Interventions: This group will perform high-intensity interval training exercises with 60-second intervals on the treadmill for 12 weeks and 24 training sessions. Indeed, there will be two training sessions in a week. The group's training program involves 60-second activity intervals with the intensity of 100% maximal aerobic power, with 60-second passive recovery among them. Each training session continues for 35 minutes.</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 There is no any further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Lobat Majidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh Ave</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517839131</zip>
        <telephone>+98 81 3838 1740</telephone>
        <email>lobat.majidi@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Lobat Majidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh Ave</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517839131</zip>
        <telephone>+98 81 3838 1740</telephone>
        <email>lobat.majidi@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of the subjects must be between 40-80 years old-age
The subjects must undergo the coronary artery bypass grafting surgery</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>There are disabling motor disorders in the patient
The patient undergoes reconstructive valve surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischemic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: High-intensity interval training Group with Short Activity Interventions: This group will perform high-intensity interval training exercises with 15-second intervals on the treadmill for 12 weeks and 24 training sessions. Indeed, there will be two training sessions in a week. The group's training program involves 15-second activity intervals with the intensity of 100% maximal aerobic power, with 15-second passive recovery among them. Each training session continues for 35 minutes.</i_keyword>
      <i_keyword>Control group: This group will participate in the routine rehabilitation program of the Hamadan Farshchian Hospital for 12 weeks and 24 training sessions. Indeed, there will be two training sessions in a week. Each training session continues for 35 minutes. The group's training program involves aerobic continuous moderate-intensity training on the treadmill.</i_keyword>
      <i_keyword>Second intervention group: High-intensity interval training Group with intermediate Activity Interventions: This group will perform high-intensity interval training exercises with 60-second intervals on the treadmill for 12 weeks and 24 training sessions. Indeed, there will be two training sessions in a week. The group's training program involves 60-second activity intervals with the intensity of 100% maximal aerobic power, with 60-second passive recovery among them. Each training session continues for 35 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maximal aerobic power. Timepoint: Before and after the treatment. Method of measurement: Bruce treadmill test.</prim_outcome>
      <prim_outcome>Heart rate variability. Timepoint: Before and after the treatment. Method of measurement: Electrocardiogram assessment of the patient.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before and after the treatment. Method of measurement: Heart disease patient's questionnaire.</prim_outcome>
      <prim_outcome>Lower extremity muscle strength. Timepoint: Before and after the treatment. Method of measurement: One repetition maximum test of the leg press.</prim_outcome>
      <prim_outcome>Systolic and diastolic function of cardiac left ventricle. Timepoint: Before and after the treatment. Method of measurement: Echocardiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Resting heart rate of the patient. Timepoint: Before and after the treatment. Method of measurement: Polar heart rate monitoring.</sec_outcome>
      <sec_outcome>Recovery heart rate of the patient. Timepoint: Before and after the treatment. Method of measurement: Polar heart rate monitoring.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before and after the treatment. Method of measurement: Mercury manometer.</sec_outcome>
      <sec_outcome>Body composition of the patient. Timepoint: Before and after the treatment. Method of measurement: Body composition analyzer.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-07</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
