<?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>IRCT20220103053609N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-19</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Pulmonary Telerehabilitation in Patients with Covid-19</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of Telerehabilitation on Pulmonary Functions in Discharged Patients with Covid-19; A Single-Blind Parallel-Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61034</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this clinical trial study, 60 patients with a previous diagnosis of Covid-19 and discharged from the hospital randomely will be included in the study .For random allocation of individuals in the study groups (intervention or intervention group and comparison or comparison group), the method of random allocation with block method (Block Randomization) will be used In this method, blocks with siza of six (including three people in the intervention group and three people in the comparison group) with a ratio of 1: 1 will be used. Random Allocation software will be used to generate random sequences. For concealment, the random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified on the cards and these cards are placed inside the sealed envelopes in order .In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined, Blinding description: This study is single blinded and blinding is done only on the analyzer without knowledge  about two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pulmonary telerehabilitation will be done through communication via video call with the help of WhatsApp program. In each session, about ten types of breathing exercises (for example, diaphragmatic breathing exercises,hand massage, rib breathing, etc.) are taught to the patient and then performed under the supervision of the therapist. This program is done for two weeks and one hour session every week and all these exercises are done daily by the patient until the end of  third week,  which is the time of the final follow-up. Intervention 2: Control group:Pulmonary rehabilitation will be done in rehabilitation center of shohada Tajrish Hospital. In each session, about ten types of breathing exercises (for example, diaphragmatic breathing exercises,hand massage, rib breathing, etc.) are taught to the patient and then performed under the supervision of the therapist. This program is done for two weeks and one hour session every week and all these exercises are done daily by the patient until the end of  third week,  which is the time of the final follow-up.</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 patient data can be shared through files after identifying them.

When:
Access period 1 month after printing the results

To whom:
The data will be available only to researchers working in academic and scientific institutions.

Conditions:
Any use to help advance science is unrestricted.

Where to obtain:
Email address to mahsa ghorbanzadeh
Mahsaghorbanzadeh1992@gmail.com

How to obtain:
After sending an email to request, they can access the information within a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa ghorbanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 5, No 5, eastern Nazari alley, Sadaf St, western Sarv St, Saadatabad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998845739</zip>
        <telephone>+98 21 2219 4207</telephone>
        <email>Mahsaghorbanzadeh1992@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahsa ghorbanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 5, No 10, eastern Nazari alley, Sadaf St, western Sarv St, Saadatabad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998845739</zip>
        <telephone>+98 21 2219 6207</telephone>
        <email>Mahsaghorbanzadeh1992@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Patients who were diagnosed with Covid-19 and discharged from the hospital. 2- Patients who are desired to participate in the study. 3- Patients aged between 18 to 80 years. 4- Having accessibility to the Internet.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1- Patients who are unwilling to continue their participation in the study. 2- Having chronic diseases, such as pulmonary disease, kidney diseases, neurologic disease,  high blood pressure, uncontrolled heart disease, rheumatic diseases, cognitive disorders and psychological problems, and musculoskeletal disease. 3. Patients who have undergone any physiotherapy. 4. Patients who have participated in any rehabilitation programs during the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Covid-19</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: Pulmonary telerehabilitation will be done through communication via video call with the help of WhatsApp program. In each session, about ten types of breathing exercises (for example, diaphragmatic breathing exercises,hand massage, rib breathing, etc.) are taught to the patient and then performed under the supervision of the therapist. This program is done for two weeks and one hour session every week and all these exercises are done daily by the patient until the end of  third week,  which is the time of the final follow-up.</i_keyword>
      <i_keyword>Control group:Pulmonary rehabilitation will be done in rehabilitation center of shohada Tajrish Hospital. In each session, about ten types of breathing exercises (for example, diaphragmatic breathing exercises,hand massage, rib breathing, etc.) are taught to the patient and then performed under the supervision of the therapist. This program is done for two weeks and one hour session every week and all these exercises are done daily by the patient until the end of  third week,  which is the time of the final follow-up.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life based on SF-36 score. Timepoint: Just before rehabilitation and 3 weeks later. Method of measurement: SF-36 questionnaire, Clinical Assessment, finger O2 Saturation monitor.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate checked by pulse oxymeter. Timepoint: Just before intervention and 3 weaks later. Method of measurement: by pulse oxymeter.</sec_outcome>
      <sec_outcome>Severity of dyspnea based on borge scale. Timepoint: Just before rehabilitation and 3 weaks later. Method of measurement: Borge scale.</sec_outcome>
      <sec_outcome>Blood oxygen saturation checked by pulse oxymeter. Timepoint: Just before rehabilitation and 3 weaks later. Method of measurement: Puls oxymeter.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-14</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Tehran, Ghods Town (West), between South Flamek and Zarafshan, Iran TV St. - Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
