<?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>IRCT20210927052610N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-28</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effect of exercise in patients with cardiac disease</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of rehabilitation at home compared to  rehabilitation at standard center on risk factors, quality of life and adherence to treatment in patients with cardiac disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59055</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: To perform random allocation and divide the samples between two groups A (exercise in the center) and group B (exercise at home), first using random allocation software version 1, we generate a random sequence by simple random allocation method. Each of numbers 1 to 62 is assigned to the intervention group A or B. When patients are referred, the first person eligible for number 1 is taken, and the last person eligible for number 62 is assigned, respectively, and assigned to the group. A and B It is determined that in order to be blind to the random allocation of clients, the random allocation table is given to a third person who is out of the study and the researcher of the intervention group calls the third person by phone or text message before specializing.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiac patients rehabilitation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:Doing exercise in a standard center Using treadmills and bicycles ,3 sessions per week, each session 50 minutes, a total of 36 sessions over 3 months. Intervention 2: Intervention group 2: Exercise at home, 30 minutes of walking daily, 5 days a week for 3 months.</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:
Information on the main outcome

When:
6 months after the publication of the article

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
Confirming the responsible person

Where to obtain:
Dr najmeh dehghanizadeh

How to obtain:
By sending a request to the email of the person in charge dr.n.dehghanizadeh@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh Dehghanizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 4, Floor 5, phase 5, Ahmadi Roshan residential complex, Ebne Sina blvd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915888884</zip>
        <telephone>+98 35 9100 2550</telephone>
        <email>dr.n.dehghanizadeh@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Najmeh Dehghanizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 4, Floor 5, phase 5, Ahmadi Roshan residential complex, Ebne Sina blvd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915888884</zip>
        <telephone>+98 35 9100 2550</telephone>
        <email>dr.n.dehghanizadeh@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Cardiac out put more than 40%
No ventricular arrhytmias and atrial fibrillation
Having a normal answer to exercise test
Age of 30_75 years
Clinically stable</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Arrhythmia and uncontrolled blood pressure
Uncontrolled Diabetes
Systemic and pulmonary diseases limiting exercise
Physical disabilities and any restrictive exercise conditions
Severe valvular cardiac disease and known or suspected aortic dissection
Patient dissatisfaction</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 1:Doing exercise in a standard center Using treadmills and bicycles ,3 sessions per week, each session 50 minutes, a total of 36 sessions over 3 months</i_keyword>
      <i_keyword>Intervention group 2: Exercise at home, 30 minutes of walking daily, 5 days a week for 3 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score. Timepoint: The quality of life questionnaire sf36 is completed before the start of the rehabilitation program and after the completion of rehabilitation sessions. Method of measurement: Quality of Life Questionnaire short form 36.</prim_outcome>
      <prim_outcome>Lipid profile and fasting blood glucose. Timepoint: Lipid profile and fasting blood glucose is measured before the start of the rehabilitation program and after the completion of rehabilitation sessions. Method of measurement: Level of fasting blood glucose and lipid profile is measured in labratory via Through blood sampling.</prim_outcome>
      <prim_outcome>Treatment adherence. Timepoint: The treatment adherence form is completed at the beginning and end of the rehabilitation program. Method of measurement: Treatment adherence medanlo questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life score. Timepoint: Sf36 form is completed before exercise and after 36 exercise sessions. Method of measurement: Short Form 36 quality of life questionnaire.</sec_outcome>
      <sec_outcome>Treatment adherence score. Timepoint: Modanloo questionarer form is completed before exercise and after 36 exercise sessions. Method of measurement: Treatment Adherence madanloo questionnaire.</sec_outcome>
      <sec_outcome>Lipid profile level. Timepoint: Lipid profile is measured before the start of exercise and after 36 sessions of rehabilitation. Method of measurement: Blood lipids are measured in the laboratory through a blood sample.</sec_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: Fasting blood sugar levels are measured before exercise and after 36 sessions of rehabilitation. Method of measurement: Fasting blood glucose is measured in the laboratory through a blood sample.</sec_outcome>
      <sec_outcome>Blood pressure level. Timepoint: At the beginning of the rehabilitation program and at the end of the rehabilitation sessions. Method of measurement: Use a sphygmomanometer.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-02</approval_date>
        <contact_name>Ethics committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam blvd, Professor Hesabi blvd. Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
