<?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>IRCT20240413061474N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-22</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aerobic exercises in pulmonary hypertension (PH) patients with chronic obstructive pulmonary disease (COPD)</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aerobic exercises on antioxidant indices of pulmonary hypertension (PH) patients with chronic obstructive pulmonary disease (COPD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77478</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: For randomization, a simple randomization method is used with the help of a table of random numbers. For this purpose, two groups are named A and B. We choose one of the rows of the table of random numbers at will and the numbers of each row will be between 0 and 9. We assign numbers 0-4 to treatment A and numbers 5-9 to treatment B, Blinding description: Clinical evaluations will be performed by blinded evaluators who are unaware of the interventions assigned to the participants. So that each evaluator receives codes for each patient that are related to training groups. Therefore, the type of grouping and the type of intervention cannot be identified by the clinical assessor.</study_design>
      <phase>3</phase>
      <hc_freetext>Pulmonary hypertension (PH) with chronic obstructive pulmonary disease (COPD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, COPD patients diagnosed with pulmonary hypertension according to the protocol, perform aerobic exercises including diaphragmatic breathing exercises and lip bud breathing on the bed, as well as stretching exercises and chest expansion for a total of ten minutes. Then the patient goes to the exercise room, and with an intensity equivalent to 60% of the six-minute walking test, they perform aerobic exercise as follows: At first, the patient walks on a treadmill for 5 minutes at a speed of 1 km/h. (warming up), then he exercises for 15 minutes at a speed equal to 60% of the walking test for six minutes (he continues to walk) and in the last 5 minutes he slows down again at a speed of 2 km/h. slow down. After the end of the exercise, stretching exercises for the lower limb muscles are performed on the treadmill for 10 minutes. Intervention 2: Control group: In the control group, COPD patients diagnosed with pulmonary hypertension only perform physical therapy exercises on the bed, including diaphragmatic breathing and lip bud breathing on the bed, as well as stretching exercises and chest expansion for a total of ten 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>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>Seyed Bashir Mirtajani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Masih Daneshvari Hospital, Darabad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956944413</zip>
        <telephone>+98 21 2610 1000</telephone>
        <email>bashirmirtajani67@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aboozar Mojibian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Masih Daneshvari Hospital, Darabad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956944413</zip>
        <telephone>+98 21 2610 1000</telephone>
        <email>dr.a.mojibian@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 more than 18 years
Diagnosis of PH through echocardiography
Pulmonary arterial pressure (PAP) more than 35
Signing the written consent form to participate in the research project</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient's unwillingness to continue participating in the research project, active cancer, or any disorder prohibiting rehabilitation exercises</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I27.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other secondary pulmonary hypertension</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, COPD patients diagnosed with pulmonary hypertension according to the protocol, perform aerobic exercises including diaphragmatic breathing exercises and lip bud breathing on the bed, as well as stretching exercises and chest expansion for a total of ten minutes. Then the patient goes to the exercise room, and with an intensity equivalent to 60% of the six-minute walking test, they perform aerobic exercise as follows: At first, the patient walks on a treadmill for 5 minutes at a speed of 1 km/h. (warming up), then he exercises for 15 minutes at a speed equal to 60% of the walking test for six minutes (he continues to walk) and in the last 5 minutes he slows down again at a speed of 2 km/h. slow down. After the end of the exercise, stretching exercises for the lower limb muscles are performed on the treadmill for 10 minutes.</i_keyword>
      <i_keyword>Control group: In the control group, COPD patients diagnosed with pulmonary hypertension only perform physical therapy exercises on the bed, including diaphragmatic breathing and lip bud breathing on the bed, as well as stretching exercises and chest expansion for a total of ten minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Test distance of 6 minutes walk. Timepoint: Before and after rehabilitation. Method of measurement: Six minute walk test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glutathione peroxidase (GPx). Timepoint: Before and after rehabilitation. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Catalase. Timepoint: Before and after rehabilitation. Method of measurement: Spectrophotometry.</sec_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: Spectrophotometry. Method of measurement: Before and after rehabilitation.</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>2024-04-23</approval_date>
        <contact_name>Ethics Committee of Tuberculosis and Lung Disease Research Institute of Shahid Beheshti University o</contact_name>
        <contact_address>Darabad, Masih Daneshvari Hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
