<?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>IRCT20181122041725N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-12</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cardiac rehabilitation in patients with myocardial infarction during the COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Exercise-based Cardiac Rehabilitation on the volume and size of heart valves and quality of life in myocardial infarction patients with during the COVID-19 pandemic period</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65446</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: First, we talk to patients who have indications for rehabilitation about the advantages and disadvantages of both home rehabilitation and in-hospital rehabilitation methods and then Patients who have the basic conditions for both methods of rehabilitation will be randomized. Eligible patients were assigned to the intervention and control groups through the block  randomization method. In this method, treatment blocks are arranged randomly with letters A and B. And we use blocks of 3, 6 and 4, so that the size of the tiles is the same. And by putting the random blocks together, we will create a balanced random list of two treatment groups, and until the sample size of the two groups is filled, random allocation will continue using the above blocks, Blinding description: In this study, blindness was performed in a single blind method and the physician (researcher) and the patient are aware of what kind of rehabilitation is being done for the patient, but the statistician does not know which patient is being rehabilitated at supervised exercise And which of the patients was rehabilitated in the routine care.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Effect of program cardiac rehabilitation in myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group program, included supervises exercise and walking (monitored via smart wristbands), as well as follow-up phone calls, for 3 month (three sessions per week). Intervention 2: Control group: The control group also perform the usual cardiac rehabilitation program recommendations by the physician to walk 40 minutes (three sessions per week), but they did not have any supervised exercise training during this period. During the study, all the participants (the intervention and control groups) receive their usual medications.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All potential data can be shared after unidentifiable people

When:
Start of access period 6 months after printing results

To whom:
Researchers working in academia and scientific

Conditions:
The necessary condition for submitting a request for access to data or documentation of the use of data for the purposes of protection, treatment of patients.

Where to obtain:
Cardiovascular research center shahid Rahimi Hospital korramabad, Mostafa Dehghani 
Dehghani.m66@gmail.com

How to obtain:
The applicant will receive the document within one week of the request by email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, West Kakavand Street., Alavi Square</address>
        <city>Korramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6814664535</zip>
        <telephone>+98 66 3333 6150</telephone>
        <email>dehghani.m66@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, West Kakavand Street., Alavi Square</address>
        <city>Korramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6814664535</zip>
        <telephone>+98 66 3333 6150</telephone>
        <email>dehghani.m66@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of myocardial infarction</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe aortic stenosis
Suffering from nervous and mental illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I22.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Subsequent ST elevation (STEMI) myocardial infarction of unspecified site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group program, included supervises exercise and walking (monitored via smart wristbands), as well as follow-up phone calls, for 3 month (three sessions per week).</i_keyword>
      <i_keyword>Control group: The control group also perform the usual cardiac rehabilitation program recommendations by the physician to walk 40 minutes (three sessions per week), but they did not have any supervised exercise training during this period. During the study, all the participants (the intervention and control groups) receive their usual medications.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Left ventricular end-systolic and end-diastolic dimension. Timepoint: Before and after 3 month of cardiac rehabilitation. Method of measurement: Echocardiography device.</prim_outcome>
      <prim_outcome>Left ventricular end-systolic and end-diastolic volume. Timepoint: Before and after 3 month of cardiac rehabilitation. Method of measurement: Echocardiography device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stroke volume. Timepoint: Before and after 3 month of cardiac rehabilitation. Method of measurement: Echocardiography device.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-27</approval_date>
        <contact_name>Ethics committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>No. 2, Lorestan University of Medical Sciences., Anooshirvan Rezaei Square خرم آباد Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
