<?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>IRCT20200418047118N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-09</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of rehabilitation in heart patients</public_title>
      <acronym>CVR</acronym>
      <scientific_title>Effect of a Cardiac Rehabilitation Course on Left ventricular Function and Hemodynamic Heart factors in Patients with Congestive Heart Failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47356</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>congestive heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: It consists of 20 patients who, with full awareness and satisfaction for two months, will take part in three regular sessions of cardio rehabilitation training each week.Patients have specific exercises with different devices such as:1- Ergoline treadmill made in Germany. 2. Ergoline bicycle  made in Germany. 3-Ergoline handmade bicycles made in Germany.Also, the patient's blood pressure will be measured by a manometer  and heart rate monitor, and the amount of oxygen in the blood will be measured by the pulse oximeter, Beurer cardiofrequency tester before, after, and during exercise. Intervention 2: Control group: Includes 20 patients who are physically similar to the experimental group who do not participate in cardiac rehabilitation exercises and they will be asked to only participate in the initial and final exams and evaluations of this course with full satisfaction and awareness, as well as the patients of the experimental group.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>َAkbar Pejhan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sabzevar University of Medical Sciences Campus Complex; Above the tombs of the unknown martyrs; Tohidshahr Boulevard</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617213112</zip>
        <telephone>+98 51 4401 8443</telephone>
        <email>pejhana@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Marefati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cardiac Rehabilitation Department, second floor, Heshmatieh Hospital, next to the central headquarters, Asadabadi Street</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873136</zip>
        <telephone>+98 51 4401 1663</telephone>
        <email>H.marefati@yahoo.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with heart disorders, such as impaired bowel function
Decreased cardiac output
Increased intracardiac pressure function
Disabling symptoms such as fatigue, pain, peripheral edema
Decreased respiratory function
Progressive hormonal and endothelial nerve disorders
Sports intolerance
Weak prognosis
Low quality of life
Age between 40 and 80 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of stroke
Extensive damage to the anterior myocardial area
Reconstructive vascular or regenerative angina procedures in the last 3 months
Orthopedic disorder
Alcohol or drug use
Patients with pacemakers or defibrillators
Flutter and atrial fibrillation
Insulin-dependent diabetes mellitus
Chronic obstructive pulmonary disease
Severe renal impairment
Non-cardiac comorbidities</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>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: It consists of 20 patients who, with full awareness and satisfaction for two months, will take part in three regular sessions of cardio rehabilitation training each week.Patients have specific exercises with different devices such as:1- Ergoline treadmill made in Germany. 2. Ergoline bicycle  made in Germany. 3-Ergoline handmade bicycles made in Germany.Also, the patient's blood pressure will be measured by a manometer  and heart rate monitor, and the amount of oxygen in the blood will be measured by the pulse oximeter, Beurer cardiofrequency tester before, after, and during exercise.</i_keyword>
      <i_keyword>Control group: Includes 20 patients who are physically similar to the experimental group who do not participate in cardiac rehabilitation exercises and they will be asked to only participate in the initial and final exams and evaluations of this course with full satisfaction and awareness, as well as the patients of the experimental group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of people whose ejection fraction  are more than 30 percent and less than 50 percent. Timepoint: Measure the heart ejection fraction  before the start of the study and at the end of the study after 24 practice sessions. Method of measurement: Two-dimensional echocardiography machine.</prim_outcome>
      <prim_outcome>Recovery rate in cardiac function factors. Timepoint: Before and after the study, during the rehabilitation period and during training. Method of measurement: Using a mercury pressure-gauge , pulse oximeter.</prim_outcome>
      <prim_outcome>Maximum and minimum hemodynamic pressure rate. Timepoint: At the end of the cardiac rehabilitation period. Method of measurement: By related formulas and equations.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maximum heart capacity (vo2). Timepoint: During rehabilitation exercises. Method of measurement: By sports test and specialized equation test.</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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-26</approval_date>
        <contact_name>Sabzevar University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Cardiac Rehabilitation Department, second floor, Heshmatieh Hospital, next to the central headquarters, Asadabadi Street, Sabzevar. IRAN Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
