<?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>IRCT20230305057618N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-14</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of respiratory and peripheral muscles training on pulmonary and physiological performance in COVID-19 patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of respiratory and peripheral muscles training on pulmonary and physiological performance in COVID-19 patient</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69000</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Based on the table of random numbers, the patients included in the study will receive random numbers. By receiving codes 1, 2, 3, etc., they are placed in each of the three treatment groups. By receiving the number 1 (4, 7, 10, etc.), it enters group one. At first, he enters the pre-test stage and then begins the respiratory muscles training . By receiving code 2 (5, 8, 11, etc.), it is placed in the second group. They enter the pre-test stage. Then they participate in the peripheral muscles training . By receiving code 3 (6, 9, 12, etc.), it is placed in the third group (control). They enter the pre-test stage. They then continue to study. The treatment starts with the main therapist, but the results and interpretation are the responsibility of the people who are blind to the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1- Respiratory muscle training: They participate in a six-week training period. In addition to breathing training, these exercises include diaphragmatic breathing exercises, pursed lip breathing exercises, cough exercises, and stretching exercises. Exercises are done twice a week for one hour at home. Supervision of exercises is done through video and social networks. Intervention 2: Intervention group 2- Peripheral muscle training: They participate in a six-week training period. This course includes breathing, muscle, balance, aerobic and stretching exercises. Exercises are done twice a week for one hour at home. Exercises are done at home. Supervision of exercises is done through video and social networks. Intervention 3: Control group: The test group is asked not to participate in any exercise program during the research period and to continue their daily diet and to report any changes such as illness, stress, etc.</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:
Clinical trial data will be published as an article

When:
6 months after results are published, access begins

To whom:
Researchers working in academic and scientific institutions

Conditions:
Related scientific research

Where to obtain:
Sports Physiology Research Center, Baqiyatullah University.

How to obtain:
Approved research plan documents

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Sobhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vanak Square, Mulla Sadra St., Sheikh Bahai St., Baqiyatullah University, Sports Physiology Research Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 4391</telephone>
        <email>sobhani518@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Nabavinik</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sports Physiology Research Center, Baqiyatullah University, Sheikh Bahai St., Mulla Sadra St., Vanak Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 4391</telephone>
        <email>hossein.nabavinik@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pneumonia confirmed by Pulmonologist (having signs and radiographic evidence of pneumonia)
Stable clinical condition
regular participation in the treatment process (before participating in the research)
Being interested in participating in training courses</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pulmonary resection
Neurological disease
Mental illness
COPD disease
A history of orthopedic and neurological disease that prevents exercise
Uncontrolled blood pressure
Cardiovascular disease
Pregnancy and breastfeeding status</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus infection, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1- Respiratory muscle training: They participate in a six-week training period. In addition to breathing training, these exercises include diaphragmatic breathing exercises, pursed lip breathing exercises, cough exercises, and stretching exercises. Exercises are done twice a week for one hour at home. Supervision of exercises is done through video and social networks.</i_keyword>
      <i_keyword>Intervention group 2- Peripheral muscle training: They participate in a six-week training period. This course includes breathing, muscle, balance, aerobic and stretching exercises. Exercises are done twice a week for one hour at home. Exercises are done at home. Supervision of exercises is done through video and social networks.</i_keyword>
      <i_keyword>Control group: The test group is asked not to participate in any exercise program during the research period and to continue their daily diet and to report any changes such as illness, stress, etc.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiratory volumes. Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.</prim_outcome>
      <prim_outcome>Maximal inspiratory mouth pressures. Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.</prim_outcome>
      <prim_outcome>Maximal expiratory mouth pressures. Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.</prim_outcome>
      <prim_outcome>Maximal  Voluntary Ventilation. Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.</prim_outcome>
      <prim_outcome>Diffusing capacity for carbon monoxide. Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.</prim_outcome>
      <prim_outcome>Ratio diffusing capacity for carbon monoxide to Alveolar Volume (DLCO/VA). Timepoint: Before and after the intervention. Method of measurement: Plethysmography system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Red Blood Cell Count or RBC. Timepoint: Before and after the intervention. Method of measurement: CBC blood test.</sec_outcome>
      <sec_outcome>White Blood Cell Count or WBC. Timepoint: Before and after the intervention. Method of measurement: CBC blood test.</sec_outcome>
      <sec_outcome>Percentage of red blood cells in a blood or Hematocrit (HCT). Timepoint: Before and after the intervention. Method of measurement: CBC blood test.</sec_outcome>
      <sec_outcome>White Blood Cell Count or WBC. Timepoint: Before and after the intervention. Method of measurement: CBC blood test.</sec_outcome>
      <sec_outcome>Count measures the platelet level in blood or Plt. Timepoint: Before and after the intervention. Method of measurement: CBC blood 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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-27</approval_date>
        <contact_name>Research Ethics Committees of Baqiyatallah Hospital</contact_name>
        <contact_address>Sheikh Bahai St., Mulla Sadra St., Vanak Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
