<?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>IRCT20190702044074N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-04</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Using of Pulmonary Rehabilitation at Home on Pulmonary Function, anxiety and depression in Patients with Covid 19</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Using of Pulmonary Rehabilitation at Home on Pulmonary Function, anxiety and depression in Patients with Covid 19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57266</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, patients with Crohn's disease admitted to Afzalipour Hospital in Kerman, based on admission and discharge criteria, voluntarily and with random allocation, are divided into two groups of intervention and control. For randomization, we use the simple random allocation method using sealed and numbered envelopes. To do this, we first prepare 70 perfectly uniform envelopes and 70 sheets of white paper. We write the control group on 35 sheets of paper and the intervention group on the other 35 sheets. Then we put the sheets of paper inside the envelope so that they are not visible from the outside. Thoroughly mix the envelopes and then number them from 1 to 70 and put them in a regular box from 1 to 70. For each patient who volunteers to enter the study and has the inclusion criteria, we select an envelope from 1 to 70, respectively, and after opening the envelope, the group to which the patient belongs will be visible.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with Covid 19.</hc_freetext>
      <i_freetext>Intervention 1: Control group: At discharge, patients will be instructed that they will receive only routine post-discharge care for four weeks, and It will be emphasized that during this period, you should refrain from other treatments recommended by others, except those prescribed by your doctor. Intervention 2: Intervention group: At the time of discharge, the patients will be given a pulmonary rehabilitation program, which is collected as an educational pamphlet, and the patient will be instructed to perform the exercises in the presence of a family member. The entire respiratory rehabilitation program at home lasts 4 weeks, which includes; First 2 weeks (one day in between; one week even days - one week individual days, 2 sessions each day and each session for 10 minutes), Second 2 weeks (one day in between; one week even days - one week individual days, 2 sessions each day and each session for 15 minutes).</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 data can be provided at the request of a specific person or organization

When:
Access period starts 6 months after the results are published

To whom:
For all people

Conditions:
It can be used after coordination with researchers and information about its use

Where to obtain:
To the responsible author mentioned in the article

How to obtain:
Refer to the e-mail address of the responsible author in the research article

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahime hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 5, Gelayol 7, Shahrak Afzalipour, Emam Reza Highroad, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7614914516</zip>
        <telephone>+98 51 3610 8307</telephone>
        <email>Fahimehashemi0@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahime hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 5, Gelayol 7, Shahrak Afzalipour, Emam Reza Highroad, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7614914516</zip>
        <telephone>+98 51 3610 8307</telephone>
        <email>Fahimehahsemi0@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with a history of non-invasive ventilation
Have a minimum literacy of reading and writing
Having a caregiver at home</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a motor or orthopedic disease
Have a history of known mental illness or taking drugs that affect the psyche or any other chronic illness (including Chronic respiratory diseases, kidney, thyroid, cancer, and of drug addiction)
Have a history of severe physical illness (such as a pacemaker, left and right heart failure, uncontrolled hypertension, and patients with Deep Vein Thrombosis and Pneumo Thrombo Embolism)
Have a history of heart or chest surgery
The patient is a professional athlete.
Having Saturation of Peripheral Oxygen less than 90% at the time of discharge.
Patients with hypoxia with little activity and their heart rate exceed 120.
A history of stressful events such as the deaths of first-degree relatives in the past six months.
The inability to make telephone calls after the patient is discharged.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: At discharge, patients will be instructed that they will receive only routine post-discharge care for four weeks, and It will be emphasized that during this period, you should refrain from other treatments recommended by others, except those prescribed by your doctor.</i_keyword>
      <i_keyword>Intervention group: At the time of discharge, the patients will be given a pulmonary rehabilitation program, which is collected as an educational pamphlet, and the patient will be instructed to perform the exercises in the presence of a family member. The entire respiratory rehabilitation program at home lasts 4 weeks, which includes; First 2 weeks (one day in between; one week even days - one week individual days, 2 sessions each day and each session for 10 minutes), Second 2 weeks (one day in between; one week even days - one week individual days, 2 sessions each day and each session for 15 minutes).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pulmonary Function. Timepoint: after intervention. Method of measurement: Spirometric index registration form.</prim_outcome>
      <prim_outcome>Anxiety and depression score. Timepoint: Before intervention, after intervention. Method of measurement: Hospital Anxiety and Depression Inventory.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-15</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences, Haft Bagh Alavi Blvd, Kerman kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
