<?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>IRCT2014081618520N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-26</date_registration>
      <primary_sponsor>Vice Chancellor for research of  Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effects of cardiac rehabilitation in the management of fatigue in patients with Coronary Heart Disease</public_title>
      <acronym></acronym>
      <scientific_title>The  effect of home-based cardiac rehabilitation on fatigue of  patients with Coronary Heart Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16773</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>CORONARY HEART DISEASE.</hc_freetext>
      <i_freetext>The study included 4 one hour education sessions of face to face in 4 consecutive days with content of home-based cardiac rehabilitation  and followed  for 8 weeks after discharging at patient’s home. First session includes learning about diseases, (side effects/ complications) and treatment, and cardiac rehabilitation simply. The second session includes education and prevention of risk factors, including smoking (smoking cessation training set), high blood lipids, hypertension, weight gain and stress. The third session consisted of diet and drug regimen in these patients. The fourth session included instruction on simple physical activity with an emphasis on hiking, sports are allowed in this group of patients and how to control pulse during exercise. &#13;
At  the end of the fourth session  review and discuss the three sessions before and  training manual of run training sessions are available to patients and Then the patient is asked for planned exercise three times per week for 8 weeks. &#13;
According to above and the need to measure learning in different time intervals, immediately after training  the evaluation of patients' rehabilitation center will be performed. Also, after the completion of the rehabilitation program at the end of the fourth week once home visit by the researcher will be made to control the rehabilitation program, trainings presented, solve problems and answers to possible questions.&#13;
Then the patient will be asked to mark the adhere to teaching in the home care form that will be give to patients.Note that this form will also be available to researchers and During the 8-week intervention, the researcher will contact with patients once a week  to emphasize on the concepts taught,  ensure of doing the exercises and in the event of a problem, go back to their homes.Also the phone number of researcher will give to patients to contact in case of any problem or question. At the end of 8 weeks  of intervention with visit the patients in their homes , they will be asked to fill questionnaire fatigue again.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeedeh Piri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,to the Hospital of Shahid Rajai, intersection Niayesh, Valiasr street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 218865536671</telephone>
        <email>s_piri@sbmu.ac.ir ; saeedepiri@yahoo.com</email>
        <affiliation>Faculty of Nursing and Midwifery  Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>saeedeh piri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,to the Hospital of Shahid Rajai, intersection Niayesh, Valiasr street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 218865536671</telephone>
        <email>s_piri@sbmu.ac.ir ; saeedepiri@yahoo.com</email>
        <affiliation>Faculty of Nursing and Midwifery  Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>(Inclusion criteria: Patients aged 35-70 years;  &#13;
The patient's vital signs (pulse and respiration) are stable for the rehabilitation program;  &#13;
6-4 weeks after the last patient is discharged; The patient does not have disease limited mobility;&#13;
Patients with uncontrolled heart failure, arrhythmia's and angina are not flaky;absence of  Mental disorders and related drugs; Patients not treated with drugs that reduce fatigue and sedatives such as amantadine and .... ; The patient has the ability to understand speech in Farsi; The patient is literate; The patient's ability to conduct training sessions of rehabilitation .&#13;
Patients have access to a phone; Local and systemic complications after surgery  is not present and  Exclusion criteria: Failure to follow the recommended training and exercise; cancellation and unwillingness to continue the study; the incidence of mental disorders such as hypertension, hyperglycemia, etc.)</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20-I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic Ischaemic Heart Disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The study included 4 one hour education sessions of face to face in 4 consecutive days with content of home-based cardiac rehabilitation  and followed  for 8 weeks after discharging at patient’s home. First session includes learning about diseases, (side effects/ complications) and treatment, and cardiac rehabilitation simply. The second session includes education and prevention of risk factors, including smoking (smoking cessation training set), high blood lipids, hypertension, weight gain and stress. The third session consisted of diet and drug regimen in these patients. The fourth session included instruction on simple physical activity with an emphasis on hiking, sports are allowed in this group of patients and how to control pulse during exercise. &#13;
At  the end of the fourth session  review and discuss the three sessions before and  training manual of run training sessions are available to patients and Then the patient is asked for planned exercise three times per week for 8 weeks. &#13;
According to above and the need to measure learning in different time intervals, immediately after training  the evaluation of patients' rehabilitation center will be performed. Also, after the completion of the rehabilitation program at the end of the fourth week once home visit by the researcher will be made to control the rehabilitation program, trainings presented, solve problems and answers to possible questions.&#13;
Then the patient will be asked to mark the adhere to teaching in the home care form that will be give to patients.Note that this form will also be available to researchers and During the 8-week intervention, the researcher will contact with patients once a week  to emphasize on the concepts taught,  ensure of doing the exercises and in the event of a problem, go back to their homes.Also the phone number of researcher will give to patients to contact in case of any problem or question. At the end of 8 weeks  of intervention with visit the patients in their homes , they will be asked to fill questionnaire fatigue again</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: Before and 8 weeks after intervention. Method of measurement: Piper Fatigue Questionnaire.</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>Vice Chancellor for research of  Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-12-08</approval_date>
        <contact_name>Ethics Committee Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>next to the Ayatollah Taleghani Hospital, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
