<?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>IRCT20221012056156N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-02</date_registration>
      <primary_sponsor>University of Marine Sciences and Technologies</primary_sponsor>
      <public_title>The effect of aerobic activity on recovered patients from COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of aerobic exercise on immune and inflammatory indicators in patients improved from COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66375</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, calls are made in Abadan and Khorramshahr cities. Then, among the volunteers who declare their readiness, 24 are selected based on the criteria for entering the research. Subjects are placed in two groups by simple random method. In the simple random method, lottery is used. In this way, each person is assigned a number. Then the folded sheets containing the number of each candidate are placed in a container. Based on the lottery, the above numbers will be placed in two aerobic training group (12 people) and the control group (12 people), respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intensity of training in the first four weeks is 50 to 60% of the maximum reserve heart rate, and from the fifth to the eighth week, 60 to 70% of the reserve heart rate is considered. The training time started from 15 minutes in the first week and 5 minutes are added to the training time every week until the fourth week. Due to the increase in training intensity, 20 minutes will be added to the training time in the fifth week and 5 minutes will be added to the training time every week until the end of the training period. Intervention 2: Control group: they don't receive any 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>Davar Rezaeimanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koi-e-Asatid Street</address>
        <city>Khorramshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64199-34619</zip>
        <telephone>+98 61 5353 1938</telephone>
        <email>davarrezaee@yahoo.com</email>
        <affiliation>Khorramshahr Marine Science and Technology University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Davar Rezaeimanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koi-e-Asatid Street</address>
        <city>Khorramshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64199-34619</zip>
        <telephone>+98 61 5353 1938</telephone>
        <email>davarrezaee@yahoo.com</email>
        <affiliation>University of Marine Sciences and Technologies</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male patients who recovered from COVID-19
VO2 max above 25 mL/Kg.min-1
Ability to participate in the training program</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>participation in sports within the past year
Taking medicines 
Smoking and alcohol drinking
Suffering from other diseases</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intensity of training in the first four weeks is 50 to 60% of the maximum reserve heart rate, and from the fifth to the eighth week, 60 to 70% of the reserve heart rate is considered. The training time started from 15 minutes in the first week and 5 minutes are added to the training time every week until the fourth week. Due to the increase in training intensity, 20 minutes will be added to the training time in the fifth week and 5 minutes will be added to the training time every week until the end of the training period.</i_keyword>
      <i_keyword>Control group: they don't receive any exercise intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>IL-6 plasma levels. Timepoint: One day before the training protocol and 48 hours after the last training session. Method of measurement: special kit.</prim_outcome>
      <prim_outcome>IL-10 plasma levels. Timepoint: One day before the training protocol and 48 hours after the last training session. Method of measurement: special kit.</prim_outcome>
      <prim_outcome>C-Reactive Protein – CRP. Timepoint: One day before the training protocol and 48 hours after the last training session. Method of measurement: special kit.</prim_outcome>
      <prim_outcome>Leukocytes. Timepoint: One day before the training protocol and 48 hours after the last training session. Method of measurement: special kit.</prim_outcome>
      <prim_outcome>Lymphocytes. Timepoint: One day before the training protocol and 48 hours after the last training session. Method of measurement: special kit.</prim_outcome>
      <prim_outcome>Neutrophils. Timepoint: One day before the training protocol and 48 hours after the last training session. Method of measurement: special kit.</prim_outcome>
      <prim_outcome>Monocytes. Timepoint: One day before the training protocol and 48 hours after the last training session. Method of measurement: special kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maximum oxygen consumption. Timepoint: Before and after the intervention. Method of measurement: Rockport walking test.</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>University of Marine Sciences and Technologies</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-18</approval_date>
        <contact_name>Ethics Committee of Abadan University of Medical Sciences</contact_name>
        <contact_address>At the beginning of Simeteri-e-Zulfikari Abadan Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
