<?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>IRCT201110197844N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-11</date_registration>
      <primary_sponsor>Vice chancellor for research, kerman University of Medical Sciences</primary_sponsor>
      <public_title>Post intensive care unit patient's recovery</public_title>
      <acronym></acronym>
      <scientific_title>Assessing the impact of using a self help rehabilitation program on post ICU patient's health status in university hospitals of Kerman University of Medical Sciences.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8292</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>rehabilitation in intensive care survivors.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Intervention was an educational package that consist of weekly programmed manual, exercise training CD and three appointed telephone calls for follow up. This self-help manual guide patients to a better physical and mental situation step by step with a weekly plan. Every two week a phone call was done by researcher to evaluate patients' compliance with the program.patients were persuaded to use the program and probleme solving was done. The manual has three parts. First part is a plan table for exercise and activity of daily living that learn patients how to plan according to their his/ her abilities. Second parts is general recommedations about nutrition, relaxation, smoking abstenation, return to family and social life and so on.  Third part is the grading exercising package and its guid for use that is usable with CDs. With appropriate patient's compliance and encourages of the researcher patients get ready within 6 weeks and would be reached an optimal level in term of physical and mental situation. Intervention 2: Control Group: This group did not receive any intervention.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>www.inhc.ir</results_url_link>
      <results_summary>Aims: Patients in intensive care units experience many physiological and&lt;br /&gt;&#13;
psychological complications that their recovery sometimes takes several years.&lt;br /&gt;&#13;
Life quality of intensive patients after discharge is lower than other internal and&lt;br /&gt;&#13;
surgical patients and physical problems makes a person disable in doing daily&lt;br /&gt;&#13;
activities. This study assesses the effect of using self-help rehabilitation&lt;br /&gt;&#13;
program on the life quality of the patients discharged from Intensive Care&lt;br /&gt;&#13;
Units.&lt;br /&gt;&#13;
Methods: It was a clinical trial study which was done on ninety patients of&lt;br /&gt;&#13;
internal-surgical intensive units of three hospitals in Kerman. This study was&lt;br /&gt;&#13;
done by SIP68 life quality questionnaire with three physical, psychological and&lt;br /&gt;&#13;
social areas and six dimensions in 2012. After patients’ discharged from&lt;br /&gt;&#13;
intensive care unit, they were in a general ward in tow case and control groups,&lt;br /&gt;&#13;
data were analyzed by using inferential, descriptive statistical tests and SPSS19&lt;br /&gt;&#13;
software.&lt;br /&gt;&#13;
Results: The mean score of the life quality in all the dimensions in intervention&lt;br /&gt;&#13;
group was improved statistically. The mean age of the participants was 37.2&lt;br /&gt;&#13;
(9.5). 44.99 percent (50.73) were women and 45.54 percent (49.26) were men.&lt;br /&gt;&#13;
There was no relationship between none of the demographic factors and life&lt;br /&gt;&#13;
quality.&lt;br /&gt;&#13;
Conclusions: Since intervention had remarkable effect on improvement of the&lt;br /&gt;&#13;
patients’ life quality after discharge, performing patient-centered methods is&lt;br /&gt;&#13;
effective in this area.           </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>Mansour Arab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7756341234</zip>
        <telephone>+98 34 1320 5179</telephone>
        <email>marab@kmu.ac.ir</email>
        <affiliation>Razi Nursing and Midwifery School, Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansour Arab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7754312345</zip>
        <telephone>+98 34 1320 5179</telephone>
        <email>marab@kmu.ac.ir</email>
        <affiliation>Razi Nursing and Midwifery School, Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients who stayed in ICU more than 48 hours; were mechanically ventilated ;were eager and able to participate in term of literacy and cognition state; Exclusion criteria: terminally ill patient ;patients with prolonged recovery like those with burn injury ;History of major psychological disorders as a confounding factor in psychological recovery</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Care involving use of rehabilitation procedures</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Intervention was an educational package that consist of weekly programmed manual, exercise training CD and three appointed telephone calls for follow up. This self-help manual guide patients to a better physical and mental situation step by step with a weekly plan. Every two week a phone call was done by researcher to evaluate patients' compliance with the program.patients were persuaded to use the program and probleme solving was done. The manual has three parts. First part is a plan table for exercise and activity of daily living that learn patients how to plan according to their his/ her abilities. Second parts is general recommedations about nutrition, relaxation, smoking abstenation, return to family and social life and so on.  Third part is the grading exercising package and its guid for use that is usable with CDs. With appropriate patient's compliance and encourages of the researcher patients get ready within 6 weeks and would be reached an optimal level in term of physical and mental situation.</i_keyword>
      <i_keyword>Control Group: This group did not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before and three months after intervention. Method of measurement: Sickness Impact Profile 68.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Demographic factors like age, gender, Length of stay and severity of illness score by APACHE ii. Timepoint: Before intervention. Method of measurement: Questionnaire.</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, kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-12-10</approval_date>
        <contact_name>Ethics Committee of Vice chancellor for research, Kerman University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
