<?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>IRCT20200611047727N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-14</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of various types of interval exercises in patients with COPD</public_title>
      <acronym></acronym>
      <scientific_title>The effect of interval exercises on heart rate variability in hospitalized patients with chronic obstructive pulmonary disease (COPD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68792</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization method, individual randomization unit and random number table randomization tool. For randomization, we use a table consisting of random digits from 0 to 9. Each of the figures in this table is repeated the same on average. We start from the first row of the table and move down row by row. For three treatments, we put numbers 1 to 3 for treatment A, numbers 4 to 6 for treatment B, and numbers 7 to 9 for treatment C. We continue the above process until three groups are completed, Blinding description: In order to prevent any possible complications, the doctor and clinical caregiver are fully aware of the assignment of treatment groups. Researchers responsible for data collection and analysis are not aware of the allocation of different study groups.</study_design>
      <phase>2</phase>
      <hc_freetext>Chronic obstructive pulmonary disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After warming up, the patients do 30 seconds of activity with an intensity of 85% of the maximum oxygen peak, then they do 30 seconds of recovery with 40% of the maximum oxygen peak. Patients will have passive recovery after doing 8 sets of 4 minutes. After 4 minutes of recovery, they will perform the same as above for another 8 minutes. After finishing the activity, the patients will perform cooling movements for 5 minutes. Intervention 2: Intervention group: After warming up for 5 minutes, the patients perform 4 minutes with an intensity of 85% of the maximum oxygen peak. Then they perform 3 minutes of recovery with 40% of the maximum oxygen peak. Patients perform this protocol in 3 sets for 21 minutes. Intervention 3: Control group: Patients receive only routine treatments and no exercise intervention.</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>Mohsen Abedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Masih Daneshvari Hospital, Daarabad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956944413</zip>
        <telephone>+98 21 2610 2020</telephone>
        <email>mohsenabedi110@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arezoo Mohamadifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Masih Daneshvari Hospital, Daarabad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956944413</zip>
        <telephone>+98 21 2610 2020</telephone>
        <email>arezoomohamadifar@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with COPD in Grade 2, 3 and 4
Age more than 18</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction to participate in the study
Underlying diseases such as diabetes
Nervous system diseases affecting cardiac rhythm</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic obstructive pulmonary disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After warming up, the patients do 30 seconds of activity with an intensity of 85% of the maximum oxygen peak, then they do 30 seconds of recovery with 40% of the maximum oxygen peak. Patients will have passive recovery after doing 8 sets of 4 minutes. After 4 minutes of recovery, they will perform the same as above for another 8 minutes. After finishing the activity, the patients will perform cooling movements for 5 minutes.</i_keyword>
      <i_keyword>Intervention group: After warming up for 5 minutes, the patients perform 4 minutes with an intensity of 85% of the maximum oxygen peak. Then they perform 3 minutes of recovery with 40% of the maximum oxygen peak. Patients perform this protocol in 3 sets for 21 minutes.</i_keyword>
      <i_keyword>Control group: Patients receive only routine treatments and no exercise intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Distance of 6-minute walk test. Timepoint: Before rehabilitation and 2 week after rehabilitation. Method of measurement: 6-minute walk test.</prim_outcome>
      <prim_outcome>Resting heart rate. Timepoint: Before rehabilitation and 2 weeks after rehabilitation. Method of measurement: Cardiopulmonary exercise test.</prim_outcome>
      <prim_outcome>VO2 at anaerobic threshold. Timepoint: Before rehabilitation and 2 weeks after rehabilitation. Method of measurement: Cardiopulmonary exercise test.</prim_outcome>
      <prim_outcome>Maximum heart rate. Timepoint: Before rehabilitation and 2 weeks after rehabilitation. Method of measurement: Cardiopulmonary exercise test.</prim_outcome>
      <prim_outcome>VO2 max. Timepoint: Before rehabilitation and 2 weeks after rehabilitation. Method of measurement: Cardiopulmonary exercise test.</prim_outcome>
      <prim_outcome>Standard deviation of ventricular contraction wave period. Timepoint: Before rehabilitation and 2 weeks after rehabilitation. Method of measurement: Heart rate variability holter.</prim_outcome>
      <prim_outcome>The root mean square of successive differences between normal heartbeats. Timepoint: Before rehabilitation and 2 weeks after rehabilitation. Method of measurement: Heart rate variability holter.</prim_outcome>
      <prim_outcome>High frequency. Timepoint: Before rehabilitation and 2 weeks after rehabilitation. Method of measurement: Heart rate variability holter.</prim_outcome>
      <prim_outcome>Low frequency. Timepoint: Before rehabilitation and 2 weeks after rehabilitation. Method of measurement: Heart rate variability holter.</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>2023-02-21</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Abbas Arabi St., Yemen St., 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>
