<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04415827</url>
  </required_header>
  <id_info>
    <org_study_id>520122019</org_study_id>
    <nct_id>NCT04415827</nct_id>
  </id_info>
  <brief_title>Energy Supply in Athletes and Untrained Persons With Bronchopulmonary Diseases</brief_title>
  <official_title>Study of Energy Supply in Athletes and Untrained Persons With Diseases of the Bronchopulmonary System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I.M. Sechenov First Moscow State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I.M. Sechenov First Moscow State Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study of the energy supply of bicycle ergometric load in athletes and untrained persons with&#xD;
      bronchopulmonary diseases (community-acquired pneumonia, bronchitis, chronic obstructive&#xD;
      pulmonary disease and acute respiratory viral infections, to justify the timing of the&#xD;
      resumption of training, as well as determination of the volume and intensity of physical&#xD;
      activity in training and competitive processes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. The aim of the study is to assess energy supply of bicycle ergometric load in athletes&#xD;
           and untrained persons who have suffered diseases of the bronchopulmonary system&#xD;
           (community-acquired pneumonia, bronchitis, chronic obstructive pulmonary disease and&#xD;
           acute respiratory viral infections, to justify the timing of the resumption of training,&#xD;
           as well as determining the volume and the intensity of physical activity in the training&#xD;
           and competitive processes.&#xD;
&#xD;
        2. In addition to a comprehensive general clinical, radiological (for community-acquired&#xD;
           pneumonia) and laboratory examination, all the subjects under study will undergo special&#xD;
           studies: spirography and spiroergometry, electrocardiography (ECG), and bicycle&#xD;
           ergometry.&#xD;
&#xD;
        3. The main indicators of the functional state of the cardio-respiratory system of the&#xD;
           study participants are indicators of the function of external respiration and gas&#xD;
           exchange, recorded in the initial state, after load and in the recovery period of 10 and&#xD;
           30 minutes.&#xD;
&#xD;
      Patients with diseases of the bronchopulmonary system will receive treatment according to&#xD;
      generally accepted standards of drug treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 23, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 22, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the respiratory system function at different periods of the bronchopulmonary disease</measure>
    <time_frame>The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.</time_frame>
    <description>assesment a change of respiratory rate using stress test machine &quot;Cardiovit&quot; in the initial state, after cycling and in the recovery period for 10 and 30 minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of the cardiovascular system function at different periods of the bronchopulmonary disease</measure>
    <time_frame>The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.</time_frame>
    <description>assesment a change of heart rate using stress test machine &quot;Cardiovit&quot; in the initial state, after cycling and in the recovery period for 10 and 30 minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of electrical activity of the heart at different periods of the bronchopulmonary disease</measure>
    <time_frame>The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.</time_frame>
    <description>assesment a change of the electrical activity of the heart using stress test machine &quot;Cardiovit&quot;, recording changes on an ECG (segment ST) during cycling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of pulmonary ventilation at different periods of the bronchopulmonary disease</measure>
    <time_frame>The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.</time_frame>
    <description>assesment a change of the pulmonary ventilation using stress test machine &quot;Cardiovit&quot;, determining tidal volume (l/min) in the initial state, after cycling and in the recovery period for 10 and 30 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of pulmonary gas exchange at different periods of the bronchopulmonary disease</measure>
    <time_frame>The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.</time_frame>
    <description>assesment a change of oxygen uptake (ml/min) using stress test machine &quot;Cardiovit&quot; in the initial state, after cycling and in the recovery period for 10 and 30 minutes.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Community-acquired Pneumonia</condition>
  <condition>Bronchitis</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Acute Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>Athletes with community-acquired pneumonia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>man and women, athletes, age 17-25, patients with community-acquired pneumonia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Untrained people with community-acquired pneumonia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>man and women, untrained people, age 17-25, patients with community-acquired pneumonia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Athletes with bronchitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>man and women, athletes, age 17-25, patients with bronchitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Untrained people with bronchitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>man and women, untrained people, age 17-25, patients with bronchitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Athletes with chronic obstructive pulmonary disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>man and women, athletes, age 17-25, patients with with chronic obstructive pulmonary disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Untrained people with chronic obstructive pulmonary disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>man and women, untrained people, age 17-25, patients with with chronic obstructive pulmonary disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Athletes with acute respiratory infections</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>man and women, athletes, age 17-25, patients with acute respiratory infections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Untrained people with acute respiratory infections</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>man and women, untrained people, age 17-25, patients with acute respiratory infections</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>bicycle ergometry test with spiroergometry</intervention_name>
    <description>The 1st testing will be carried out on the 28-31th day of the disease, which corresponds to the period of the expected normalization of temperature, improvement of well-being, positive dynamics of radiological (with community-acquired pneumonia) and laboratory data, the 2nd test - after 3 months, the 3rd - after 6 months and IV - after 12 months.&#xD;
Load testing will be carried out on a bicycle ergometer with an initial power of 25 watts with a further increase of 25 watts every 3 minutes. The cessation of the load will be carried out upon the appearance of signs set forth in the recommendations of the World Health Organization Expert Committee (1970)</description>
    <arm_group_label>Athletes with acute respiratory infections</arm_group_label>
    <arm_group_label>Athletes with bronchitis</arm_group_label>
    <arm_group_label>Athletes with chronic obstructive pulmonary disease</arm_group_label>
    <arm_group_label>Athletes with community-acquired pneumonia</arm_group_label>
    <arm_group_label>Untrained people with acute respiratory infections</arm_group_label>
    <arm_group_label>Untrained people with bronchitis</arm_group_label>
    <arm_group_label>Untrained people with chronic obstructive pulmonary disease</arm_group_label>
    <arm_group_label>Untrained people with community-acquired pneumonia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. the presence of written informed consent of the patient to participate in the study;&#xD;
&#xD;
          2. athletes (men and women) with a diagnosis of community-acquired pneumonia / bronchitis&#xD;
             / chronic obstructive pulmonary disease / acute respiratory viral infection on days&#xD;
             28-31 from the onset of the disease, i.e. in the stage of clinical recovery;&#xD;
&#xD;
          3. untrained individuals (men and women) with a diagnosis of community-acquired pneumonia&#xD;
             / bronchitis / chronic obstructive pulmonary disease / acute respiratory viral&#xD;
             infection;&#xD;
&#xD;
          4. age 17 - 25 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. refusal of the patient from further participation in the study;&#xD;
&#xD;
          2. non-compliance with treatment recommendations and regimen.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Viktoria S Moskvichyova</last_name>
    <role>Study Chair</role>
    <affiliation>I.M. Sechenov First Moscow State Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Viktoria S Moskvichyova</last_name>
    <phone>+79251290922</phone>
    <email>moskvicheva_viktoria@mail.ru</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Irina A Lazareva</last_name>
    <phone>+79032316255</phone>
    <email>ialazareva@mail.ru</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sechenov University</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Viktoria S Moskvichyova</last_name>
      <phone>+79251290922</phone>
      <email>moskvicheva_viktoria@mail.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>April 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sports medicine</keyword>
  <keyword>bicycle ergometry</keyword>
  <keyword>bronchopulmonary diseases</keyword>
  <keyword>spiroergometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Bronchitis</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>prohibited by Local Ethics Committee of &quot;I.M. Sechenov First Moscow State Medical University&quot;</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04415827
org study id: 520122019
nct id: NCT04415827
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Study of the energy supply of bicycle ergometric load in athletes and untrained persons with
      bronchopulmonary diseases (community-acquired pneumonia, bronchitis, chronic obstructive
      pulmonary disease and acute respiratory viral infections, to justify the timing of the
      resumption of training, as well as determination of the volume and intensity of physical
      activity in training and competitive processes.
1. The aim of the study is to assess energy supply of bicycle ergometric load in athletes
           and untrained persons who have suffered diseases of the bronchopulmonary system
           (community-acquired pneumonia, bronchitis, chronic obstructive pulmonary disease and
           acute respiratory viral infections, to justify the timing of the resumption of training,
           as well as determining the volume and the intensity of physical activity in the training
           and competitive processes.

        2. In addition to a comprehensive general clinical, radiological (for community-acquired
           pneumonia) and laboratory examination, all the subjects under study will undergo special
           studies: spirography and spiroergometry, electrocardiography (ECG), and bicycle
           ergometry.

        3. The main indicators of the functional state of the cardio-respiratory system of the
           study participants are indicators of the function of external respiration and gas
           exchange, recorded in the initial state, after load and in the recovery period of 10 and
           30 minutes.

      Patients with diseases of the bronchopulmonary system will receive treatment according to
      generally accepted standards of drug treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change of the respiratory system function at different periods of the bronchopulmonary disease
time frame: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
description: assesment a change of respiratory rate using stress test machine "Cardiovit" in the initial state, after cycling and in the recovery period for 10 and 30 minutes.
measure: Change of the cardiovascular system function at different periods of the bronchopulmonary disease
time frame: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
description: assesment a change of heart rate using stress test machine "Cardiovit" in the initial state, after cycling and in the recovery period for 10 and 30 minutes.
measure: Change of electrical activity of the heart at different periods of the bronchopulmonary disease
time frame: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
description: assesment a change of the electrical activity of the heart using stress test machine "Cardiovit", recording changes on an ECG (segment ST) during cycling.
measure: Change of pulmonary ventilation at different periods of the bronchopulmonary disease
time frame: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
description: assesment a change of the pulmonary ventilation using stress test machine "Cardiovit", determining tidal volume (l/min) in the initial state, after cycling and in the recovery period for 10 and 30 minutes.
measure: Change of pulmonary gas exchange at different periods of the bronchopulmonary disease
time frame: The 1st test will be carried out on the 28-31th day of the disease, the 2nd test - after 3 months, III - after 6 months and IV - after 12 months.
description: assesment a change of oxygen uptake (ml/min) using stress test machine "Cardiovit" in the initial state, after cycling and in the recovery period for 10 and 30 minutes.
arm group label: Athletes with community-acquired pneumonia
arm group type: Experimental
description: man and women, athletes, age 17-25, patients with community-acquired pneumonia
arm group label: Untrained people with community-acquired pneumonia
arm group type: Experimental
description: man and women, untrained people, age 17-25, patients with community-acquired pneumonia
arm group label: Athletes with bronchitis
arm group type: Experimental
description: man and women, athletes, age 17-25, patients with bronchitis
arm group label: Untrained people with bronchitis
arm group type: Experimental
description: man and women, untrained people, age 17-25, patients with bronchitis
arm group label: Athletes with chronic obstructive pulmonary disease
arm group type: Experimental
description: man and women, athletes, age 17-25, patients with with chronic obstructive pulmonary disease
arm group label: Untrained people with chronic obstructive pulmonary disease
arm group type: Experimental
description: man and women, untrained people, age 17-25, patients with with chronic obstructive pulmonary disease
arm group label: Athletes with acute respiratory infections
arm group type: Experimental
description: man and women, athletes, age 17-25, patients with acute respiratory infections
arm group label: Untrained people with acute respiratory infections
arm group type: Experimental
description: man and women, untrained people, age 17-25, patients with acute respiratory infections
intervention type: Diagnostic Test
intervention name: bicycle ergometry test with spiroergometry
description: The 1st testing will be carried out on the 28-31th day of the disease, which corresponds to the period of the expected normalization of temperature, improvement of well-being, positive dynamics of radiological (with community-acquired pneumonia) and laboratory data, the 2nd test - after 3 months, the 3rd - after 6 months and IV - after 12 months.
Load testing will be carried out on a bicycle ergometer with an initial power of 25 watts with a further increase of 25 watts every 3 minutes. The cessation of the load will be carried out upon the appearance of signs set forth in the recommendations of the World Health Organization Expert Committee (1970)
arm group label: Athletes with acute respiratory infections
arm group label: Athletes with bronchitis
arm group label: Athletes with chronic obstructive pulmonary disease
arm group label: Athletes with community-acquired pneumonia
arm group label: Untrained people with acute respiratory infections
arm group label: Untrained people with bronchitis
arm group label: Untrained people with chronic obstructive pulmonary disease
arm group label: Untrained people with community-acquired pneumonia
criteria: 
gender: All
minimum age: 17 Years
maximum age: 25 Years
healthy volunteers: No
last name: Viktoria S Moskvichyova
role: Study Chair
affiliation: I.M. Sechenov First Moscow State Medical University
last name: Viktoria S Moskvichyova
phone: +79251290922
email: moskvicheva_viktoria@mail.ru
last name: Irina A Lazareva
phone: +79032316255
email: ialazareva@mail.ru
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Respiratory Tract Infections
mesh term: Bronchitis
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No
ipd description: prohibited by Local Ethics Committee of "I.M. Sechenov First Moscow State Medical University"