<?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>IRCT20181122041725N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-19</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of home-monitored cardiac rehabilitation in patients with myocardial infarction</public_title>
      <acronym></acronym>
      <scientific_title>Effect of morning-and-evening supervised Home-Based Cardiac Rehabilitation (HBCR) program on echo and Electrocardiographic indices, as well as general health among male patients with myocardium infraction, visiting Madani hospital of Khorramabad.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35414</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible patients were assigned to the groups through the stratified randomization method. People were first divided into two strata of morning and evening. Then, the subjects were selected from the strata through the block randomization method and divided into the intervention and control groups according to the order of the selected block number and the internal arrangement of blocks. The selected block number by luck. It should be noted that to blind the person who performed the sampling and to prevent the prediction of allocation, the size of the blocks was not written in the protocol, Blinding description: This study is a double-blind clinical trial, which the patients were unaware of their allocation to the various groups  Moreover, the researcher who was collecting various consequences of interventions will not be aware of group allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Effect of Home-based cardiac rehabilitation in myocardial infarction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention groups (morning and evening) carried out the cardiac rehabilitation walking program using  pedometers. The pedometer feedback- based home cardiac rehabilitation (PFHCR) program in this research included walking at home for almost 45-60 min (5-min warm-up, 40- min walking, and 5- min cool-down and stretching exercises). Intervention 2: Control group: The control groups (morning and evening) also performed the usual cardiac rehabilitation program  without utilizing pedometer feedback.The control groups had the same cardiac rehabilitation exercise program but did not use the step counter feedback.</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:
Only part of the data, such as the original outcome information

When:
2018

To whom:
Researchers working in academia and academia

Conditions:
researchers

Where to obtain:
telephone

How to obtain:
, Phone numbers, or email addresses, along with the names and addresses of individuals

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa Dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Abdovali. Baghcheban, Cepah Boulvar</address>
        <city>Kouhdasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6841956586</zip>
        <telephone>+98 66 3263 0659</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>Shahid Abdvali, Bagcheban, Cepah Boulvar</address>
        <city>Kouhdasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6841956586</zip>
        <telephone>+98 66 3263 0659</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>1. History of angioplasty, known coronary artery disease, or angiography with moderate cardiovascular disease (mild CAD)
Lack of regular physical activity during the three months prior to the intervention, so that their activity is less than 7,500 steps per day</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Stabilized Blood Disorder
Patients who have a history of using a pacemaker</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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 groups (morning and evening) carried out the cardiac rehabilitation walking program using  pedometers. The pedometer feedback- based home cardiac rehabilitation (PFHCR) program in this research included walking at home for almost 45-60 min (5-min warm-up, 40- min walking, and 5- min cool-down and stretching exercises).</i_keyword>
      <i_keyword>Control group: The control groups (morning and evening) also performed the usual cardiac rehabilitation program  without utilizing pedometer feedback.The control groups had the same cardiac rehabilitation exercise program but did not use the step counter feedback.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Echo and Electrocardiographic parameters. Timepoint: Before and after 8 weeks of cardiac rehabilitation. Method of measurement: Echo and Electrocardiography.</prim_outcome>
      <prim_outcome>General health. Timepoint: Before and after 8 weeks of cardiac rehabilitation. Method of measurement: GHQ questionnaire 28 questions.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ejection fraction. Timepoint: Before and after 8 weeks of cardiac rehabilition. Method of measurement: Eco cardiography.</sec_outcome>
      <sec_outcome>Left ventricular peak filling the initial and final. Timepoint: Before and after 8 weeks of cardiac rehabilition. Method of measurement: Eco cardiography.</sec_outcome>
      <sec_outcome>Heart rate rest. Timepoint: Before and after 8 weeks of cardiac rehabilition. Method of measurement: Electrocardiogram.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before and after 8 weeks of cardiac rehabilition. Method of measurement: Blood pressure device.</sec_outcome>
      <sec_outcome>Mean arterial pressure (pressure Drift). Timepoint: Before and after 8 weeks of cardiac rehabilition. Method of measurement: Blood pressure 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>2018-11-05</approval_date>
        <contact_name>Ethics committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Khorram Abad - Kamalundeh - Kilometer 4 Khorramabad Road, Boroujerd Korramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
