<?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>IRCT20160516027929N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-21</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of continuous and intermittent exercise in patients with interstitial lung disease (ILD)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of continuous and interval exercise on respiratory and inflammatory indicators of patients with Interstitial lung disease (ILD) candidates for lung transplantation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67930</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done with a simple randomization method using a table of random numbers and an individual randomization unit. For randomization, we use a table consisting of random numbers 1 to 8. Each of the figures in this table is repeated the same on average. There is no discernible pattern of numerical values. In this method, each figure is assigned to a treatment group. We start from the first row of the table and move down row by row. For the two treatments that will be performed, we put numbers 1 to 4 for treatment A and numbers 5 to 8 for treatment B. We continue the above process until two groups are complete, Blinding description: This study is a blind strain and in order to prevent any kind of possible complications, the specialist doctor and the clinical caregiver are fully aware of the specialty of the treatment groups. Patients participating in the study were not blinded to the type of treatment they received. Only the researchers responsible for data analysis are not aware of the allocation of different study groups. Patient information will be provided to the data analyst in coded form in separate files.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Interstitial lung disease (ILD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, interval exercises include 2 minutes of activity with an intensity of 80% of the maximum exercise capacity, and 2 minutes of recovery with an intensity of 50% (by treadmill). Before starting their exercise program, patients do 5 minutes of warm-up exercises with an intensity of 70% of the maximum HR and at the end, they will do a 5-minute cool-down exercise with an intensity of 20-30% of the maximum HR. The duration of the exercises will be 30 minutes and over a period of 10 days. Intervention 2: Control group: Patients in the control group perform 30 minutes of continuous exercises (treadmill) with 60% of maximum exercise capacity. Before starting their exercise program, patients perform 5 minutes of warm-up exercises with an intensity of 70% of maximum HR and at the end, cool down exercises for 5 minutes. They will do 20-30% maximum HR intensity for 30 minutes during 10 days.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Fakharian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Masih Daneshvari Hospital, Daar Abad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956944413</zip>
        <telephone>+98 21 2712 2201</telephone>
        <email>fakharian_2005@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Masih Daneshvari Hospital, Daar Abad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956944413</zip>
        <telephone>+98 21 2712 2020</telephone>
        <email>mohsenabedi110@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age older than 18
Consent to participate in the study
BMI in the range of 19 to 25
Muscle force of hip flexors and knee extensors at least 4 out of 5
Patients under oxygen therapy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pulmonary hypertension
PAP above 40
Musculoskeletal problems limiting exercise</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J84.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other interstitial pulmonary diseases with fibrosis</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: In the intervention group, interval exercises include 2 minutes of activity with an intensity of 80% of the maximum exercise capacity, and 2 minutes of recovery with an intensity of 50% (by treadmill). Before starting their exercise program, patients do 5 minutes of warm-up exercises with an intensity of 70% of the maximum HR and at the end, they will do a 5-minute cool-down exercise with an intensity of 20-30% of the maximum HR. The duration of the exercises will be 30 minutes and over a period of 10 days.</i_keyword>
      <i_keyword>Control group: Patients in the control group perform 30 minutes of continuous exercises (treadmill) with 60% of maximum exercise capacity. Before starting their exercise program, patients perform 5 minutes of warm-up exercises with an intensity of 70% of maximum HR and at the end, cool down exercises for 5 minutes. They will do 20-30% maximum HR intensity for 30 minutes during 10 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PImax. Timepoint: The first day of training and the final day. Method of measurement: Body box.</prim_outcome>
      <prim_outcome>PEmax. Timepoint: The first day of training and the final day. Method of measurement: Body box.</prim_outcome>
      <prim_outcome>FEV1. Timepoint: The first day of training and the final day. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>FVC. Timepoint: The first day of training and the final day. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>TLC. Timepoint: The first day of training and the final day. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>Maximum sports capacity. Timepoint: The first day of training and the final day. Method of measurement: Six-minute walk test.</prim_outcome>
      <prim_outcome>Shortness of breath. Timepoint: The first day of training and the final day. Method of measurement: Based on the Borg scale.</prim_outcome>
      <prim_outcome>CRP. Timepoint: The first day of training and the final day. Method of measurement: Evaluation of laboratory tests.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-08</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Next to Taleghani Hospital,  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>
