<?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>IRCT20230527058305N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-21</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Investigating the effect of different exercise regimens of the first phase of cardiac rehabilitation</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of different exercise regimens of the first phase of cardiac rehabilitation on the discharge day performance of open heart surgery patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70734</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method was used to select people in these two groups. From the beginning, it was agreed that intervention group 1 would be given odd numbers and intervention group 2 would be given even numbers. Then, according to the number of sample size (32) under study, the relevant random numbers were extracted using Excel software, and each number was written on a card and placed in an envelope, and the envelopes were sealed, and on each envelope was the patient's number.Envelope number 1 will be given to the first patient who is enrolled in the study, envelope number 2 will be given to second patient , and so on.until the end of the study sample, Blinding description: In this study patients and therapist know the situation of patients in groups.only assessor do not know the situation of patients in groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Chronic ischemic heart disease. Condition 2: Rheumatic mitral valve diseases. Condition 3: Nonrheumatic mitral valve disorders. Condition 4: Multiple valve diseases. Condition 5: Rheumatic aortic valve diseases. Condition 6: Nonrheumatic aortic valve disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:cardiac rehabilitation program, which generally includes: early mobilization of the patient as soon as possible, teaching breathing exercises and organs, teaching personal care, will be given in the number of one session per day, from the day before the operation to the day of discharge. Intervention 2: Intervention group:cardiac rehabilitation program, which generally includes: early  mobilization of the patient as soon as possible, teaching breathing exercises and organs, teaching personal care, will be given in the number of two session per day, from the day before the operation to the day of discharge.(The difference between this group and intervention group 1 is in the frequency of therapeutic sessions, which is twice a day).</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 the data related to the demographic information of the patients and their related medical documents and the test results of this research can be shared.

When:
The access period starts after the article is published in the journal

To whom:
Researchers working in academic and scientific institutions

Conditions:
Research uses  for articles in the medical field

Where to obtain:
1. Oweis Rezaei at the email address oweisrezaei@gmail.com at the phone number 0098 939 374 6002
2. Dr. Farhad Azadi at the email address fa_azadi@yahoo.com

How to obtain:
First, the request is sent by the applicant to the email address of the mentioned people. Then, if the main researcher approves and after reviewing the applicant's documents, the requested data will be sent as a file

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Oweis Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dead end 15,Ali hoseini St,East Ferdows Blvd,Tehran,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1481916951</zip>
        <telephone>+98 21 4979 6260</telephone>
        <email>oweisrezaei@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Oweis Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dead end 15,ali hoseini St,East Ferdows Blvd,Tehran,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1481916951</zip>
        <telephone>+98 21 4979 6260</telephone>
        <email>oweisrezaei@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Open heart surgery(coronary artery bypass graft,valve replacement or both) candidate patients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of open heart surgery
Emergency surgery
History of recent myocardial infarction (past 6 months)
Implanted pace maker
Having chronic obstructive pulmonary disease
Severe non-cardiac disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25</hc_code>
      <hc_code>I05</hc_code>
      <hc_code>I34</hc_code>
      <hc_code>I08</hc_code>
      <hc_code>I06</hc_code>
      <hc_code>I35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischemic heart disease</hc_keyword>
      <hc_keyword>Rheumatic mitral valve diseases</hc_keyword>
      <hc_keyword>Nonrheumatic mitral valve disorders</hc_keyword>
      <hc_keyword>Multiple valve diseases</hc_keyword>
      <hc_keyword>Rheumatic aortic valve diseases</hc_keyword>
      <hc_keyword>Nonrheumatic aortic valve disorders</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:cardiac rehabilitation program, which generally includes: early mobilization of the patient as soon as possible, teaching breathing exercises and organs, teaching personal care, will be given in the number of one session per day, from the day before the operation to the day of discharge.</i_keyword>
      <i_keyword>Intervention group:cardiac rehabilitation program, which generally includes: early  mobilization of the patient as soon as possible, teaching breathing exercises and organs, teaching personal care, will be given in the number of two session per day, from the day before the operation to the day of discharge.(The difference between this group and intervention group 1 is in the frequency of therapeutic sessions, which is twice a day).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Distance walk in six minute walk test. Timepoint: Before intervention (surgery) and discharge day. Method of measurement: In this test we want from patient to walk as far as he or she can in six minute . Patient will walk in a 30 meter path up and down. There are some chairs through the path for rest.patient allowed to rest in case of fatigue or symptoms like chest pain, shortness of breath or musculoskeletal pain.the patient continues to walk until the time of six minutes is over.</prim_outcome>
      <prim_outcome>Forced vital capacity. Timepoint: Before intervention (surgery) and discharge day. Method of measurement: With spirometer (spirolab MIR company).</prim_outcome>
      <prim_outcome>Forced expiratory volume in first second. Timepoint: Before intervention (surgery) and discharge day. Method of measurement: With spirometer (spirolab MIR company).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-14</approval_date>
        <contact_name>Ethics committee of University of Social Welfare and Rehabilitation sciences</contact_name>
        <contact_address>Kodakyaar Deadend., Daneshjoo Blvd.,Evin.,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
