xml: <clinical_study>
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    <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/NCT05967039</url>
    </required_header>
    <id_info>
      <org_study_id>30135320.0.0000.5259</org_study_id>
      <nct_id>NCT05967039</nct_id>
    </id_info>
    <brief_title>Assessment of Functional Capacity in Long-COVID</brief_title>
    <official_title>Evaluation of Lung Function, Lung Ultrasound and Functional Capacity in Long-COVID Patients Who Underwent Physical Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centro Universitário Augusto Motta</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centro Universitário Augusto Motta</source>
    <oversight_info>
      <has_dmc>No</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>
        A paucity of prognostic studies in patients with post-COVID-19 syndrome (long-COVID) shows&#xD;
        the need to identify the main effects on functional capacity in the short and medium term. In&#xD;
        this regard, the evaluation of lung function, lung structure and functional capacity in&#xD;
        long-COVID patients is essential to estimate the impact of the disease. This retrospective&#xD;
        observational study aims to compare functional capacity, lung function, and lung ultrasound&#xD;
        findings in patients who underwent physical therapy to those who did not.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction: The pandemic caused by the Severe acute respiratory syndrome by coronavirus 2&#xD;
        (SARS-CoV-2) has been presented as a one of the greatest health challenges on a global scale&#xD;
        at the beginning of this millennium. Many patients need physical therapy in their recovery&#xD;
        process. A paucity of prognostic studies in patients with long-COVID shows the need to&#xD;
        identify the main repercussions on functional capacity in the short and medium term. In this&#xD;
        regard, the evaluation of lung function, lung structure and functional capacity in long-COVID&#xD;
        patients is essential to estimate the impact of the disease.&#xD;
  &#xD;
        Objective: The present study aims to compare functional capacity, lung function, and lung&#xD;
        ultrasound findings between patients diagnosed with long-COVID who underwent physical therapy&#xD;
        to those who did not.&#xD;
  &#xD;
        Methods: This is a retrospective observational study with quantitative data analysis. The&#xD;
        study will be carried out at the Pulmonary Function Laboratory of the Policlínica&#xD;
        Universitária Piquet Carneiro, from the State University of Rio de Janeiro. First, a clinical&#xD;
        evaluation will be performed. In the survey, it will be asked whether the patient had&#xD;
        undergone physical therapy treatment, so they can be allocated in the control or intervention&#xD;
        group. After that, they will answer to the Post-COVID-19 Functional Status Scale (PCFS), a&#xD;
        tool to measure functional status over time after COVID-19. Then, patients will have their&#xD;
        lung function evaluated through spirometry and impulse oscillometry (IOS). In addition, lung&#xD;
        ultrasound (LUS) images will be analyzed. And their functional capacity will be assessed&#xD;
        using the six-minute walk test (6MWT) coupled to pulmonary ventilation measurement using&#xD;
        Spiropalm® (Spiropalm 6MWT, Cosmed, Rome, Italy).&#xD;
  &#xD;
        It is expected that understanding the consequences of long-COVID on pulmonary ventilation can&#xD;
        help to design therapeutic strategies in rehabilitation services.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 8, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Six-minute walk test coupled into the measurement of pulmonary ventilation</measure>
      <time_frame>October 2023</time_frame>
      <description>The individuals will undergo the six-minute walk test coupled to the measurement of ventilation using equipment using a face mask with monitoring of ventilatory variables and vital signs on a 30-meter track where the purpose is to assess the functional capacity</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Impulse oscillometry</measure>
      <time_frame>October 2023</time_frame>
      <description>The IOS will be performed using an impulse oscillometer (Quark i2m, Cosmed, Rome Italy). During the IOS assessment, participants will be guided to stay seated, keeping the head in a neutral position, with manual support on the cheeks and with the nostrils occluded by a clip and then they will breathe usually for 40 seconds (ALBUQUERQUE et al., 2015). The values of acceptable minimum coherence will be ≥0.9 Hz. The following resistive and reactive parameters were evaluated: Rsr at 4 Hz (R4), 6 Hz (R6), 10 Hz (R10) and 20 Hz (R20); average resistance between 4-20 Hz (Rm); heterogeneity of resistance between R4 and R20 (R4-R20); resonant frequency (Fres); and area under reactance curve (AX). The values of R4, R6, R10 and R20 will be considered 34 abnormal when ≥150% of predicted (OOSTVEEN et al., 2013). A change in Fres and AX will be considered when &gt;12 Hz and &gt;3.60 cm H2O/L/s, respectively (BERGER et al., 2013).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spirometry</measure>
      <time_frame>October 2023</time_frame>
      <description>It is a procedure that allows the diagnosis of ventilatory disorders and is capable of measuring the patient's pulmonary function - evaluating the volume and velocity of the air blown. It is done with the aid of a device, the spirometer. The patient breathes into this device and internal sensors measure the amount of air and air movement in the lungs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lung ultrasound</measure>
      <time_frame>October 2023</time_frame>
      <description>Participants will perform the LUS on Aplio XG equipment Aplio XG (Toshiba Medical Systems, Tokyo, Japan) coupled to a linear transducer 7.5-10 megahertz (MHz) multi-frequency transducer or a 3.5-5 MHz convex transducer in B. All USP evaluations will be performed by the authors who, although not whether they are radiologists, they are all employees of Policlínica Piquet Carneiro and have at least least 9 years of USP experience at the participant screening site. All USP assessments will be performed by 2 examiners and, when disagreement between them will be resolved through collective discussion. With participants in a seated position, the capture of USP signals will be done in 6 areas of each hemithorax as follows (SOUMMER et al., 2012): two anterior, two side and two back. In the evaluation of the pathological signs of USP, the investigators will search for B lines &gt;2, coalescing B lines, and subpleural consolidations (MAFORT et al., 2021).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Status scale PCFS</measure>
      <time_frame>October 2023</time_frame>
      <description>The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19, being a self-administered questionnaire for the patient who will be informed: how much are you currently affected in your daily life by COVID 19? The patient will indicate in a classification from 0 to 4 their degree of functional status</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">65</enrollment>
    <condition>Post-COVID-19 Syndrome</condition>
    <condition>Long COVID</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <description>This is a control group of individuals who were diagnosed with post-COVID-19 syndrome but did not underwent Physiotherapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <description>This is an intervention group of individuals who were diagnosed with post-COVID-19 syndrome and underwent Physiotherapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physiotherapy</intervention_name>
      <description>Physiotherapy in respiratory rehabilitation</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with long-COVID-19 syndrome&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Individuals with an established diagnosis of COVID-19 (RT-PCR) who required hospitalization&#xD;
          or not, regardless of whether or not they were treated in the ICU.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients unable to perform the tests. Patients with musculoskeletal disorders not&#xD;
          associated with COVID-19. Patients with lung, heart or cerebrovascular diseases not&#xD;
          associated with COVID-19.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Agnaldo José Lopes</name>
        <address>
          <city>Rio de Janeiro</city>
          <zip>22745-271</zip>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Centro Universitario Augusto Motta</name>
        <address>
          <city>Rio De Janeiro</city>
          <zip>22745271</zip>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
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    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Functional capacity;</keyword>
    <keyword>Six-minute walk test;</keyword>
    <keyword>Spirometry;</keyword>
    <keyword>Oscillometry;</keyword>
    <keyword>Lung Ultrasound;</keyword>
    <keyword>Ventilometry;</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Post-Acute COVID-19 Syndrome</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967039
  org study id: 30135320.0.0000.5259
  nct id: NCT05967039
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A paucity of prognostic studies in patients with post-COVID-19 syndrome (long-COVID) shows
        the need to identify the main effects on functional capacity in the short and medium term. In
        this regard, the evaluation of lung function, lung structure and functional capacity in
        long-COVID patients is essential to estimate the impact of the disease. This retrospective
        observational study aims to compare functional capacity, lung function, and lung ultrasound
        findings in patients who underwent physical therapy to those who did not.
  Introduction: The pandemic caused by the Severe acute respiratory syndrome by coronavirus 2
        (SARS-CoV-2) has been presented as a one of the greatest health challenges on a global scale
        at the beginning of this millennium. Many patients need physical therapy in their recovery
        process. A paucity of prognostic studies in patients with long-COVID shows the need to
        identify the main repercussions on functional capacity in the short and medium term. In this
        regard, the evaluation of lung function, lung structure and functional capacity in long-COVID
        patients is essential to estimate the impact of the disease.
  
        Objective: The present study aims to compare functional capacity, lung function, and lung
        ultrasound findings between patients diagnosed with long-COVID who underwent physical therapy
        to those who did not.
  
        Methods: This is a retrospective observational study with quantitative data analysis. The
        study will be carried out at the Pulmonary Function Laboratory of the Policlínica
        Universitária Piquet Carneiro, from the State University of Rio de Janeiro. First, a clinical
        evaluation will be performed. In the survey, it will be asked whether the patient had
        undergone physical therapy treatment, so they can be allocated in the control or intervention
        group. After that, they will answer to the Post-COVID-19 Functional Status Scale (PCFS), a
        tool to measure functional status over time after COVID-19. Then, patients will have their
        lung function evaluated through spirometry and impulse oscillometry (IOS). In addition, lung
        ultrasound (LUS) images will be analyzed. And their functional capacity will be assessed
        using the six-minute walk test (6MWT) coupled to pulmonary ventilation measurement using
        Spiropalm® (Spiropalm 6MWT, Cosmed, Rome, Italy).
  
        It is expected that understanding the consequences of long-COVID on pulmonary ventilation can
        help to design therapeutic strategies in rehabilitation services.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Six-minute walk test coupled into the measurement of pulmonary ventilation
  time frame: October 2023
  description: The individuals will undergo the six-minute walk test coupled to the measurement of ventilation using equipment using a face mask with monitoring of ventilatory variables and vital signs on a 30-meter track where the purpose is to assess the functional capacity
  measure: Impulse oscillometry
  time frame: October 2023
  description: The IOS will be performed using an impulse oscillometer (Quark i2m, Cosmed, Rome Italy). During the IOS assessment, participants will be guided to stay seated, keeping the head in a neutral position, with manual support on the cheeks and with the nostrils occluded by a clip and then they will breathe usually for 40 seconds (ALBUQUERQUE et al., 2015). The values of acceptable minimum coherence will be ≥0.9 Hz. The following resistive and reactive parameters were evaluated: Rsr at 4 Hz (R4), 6 Hz (R6), 10 Hz (R10) and 20 Hz (R20); average resistance between 4-20 Hz (Rm); heterogeneity of resistance between R4 and R20 (R4-R20); resonant frequency (Fres); and area under reactance curve (AX). The values of R4, R6, R10 and R20 will be considered 34 abnormal when ≥150% of predicted (OOSTVEEN et al., 2013). A change in Fres and AX will be considered when >12 Hz and >3.60 cm H2O/L/s, respectively (BERGER et al., 2013).
  measure: Spirometry
  time frame: October 2023
  description: It is a procedure that allows the diagnosis of ventilatory disorders and is capable of measuring the patient's pulmonary function - evaluating the volume and velocity of the air blown. It is done with the aid of a device, the spirometer. The patient breathes into this device and internal sensors measure the amount of air and air movement in the lungs.
  measure: Lung ultrasound
  time frame: October 2023
  description: Participants will perform the LUS on Aplio XG equipment Aplio XG (Toshiba Medical Systems, Tokyo, Japan) coupled to a linear transducer 7.5-10 megahertz (MHz) multi-frequency transducer or a 3.5-5 MHz convex transducer in B. All USP evaluations will be performed by the authors who, although not whether they are radiologists, they are all employees of Policlínica Piquet Carneiro and have at least least 9 years of USP experience at the participant screening site. All USP assessments will be performed by 2 examiners and, when disagreement between them will be resolved through collective discussion. With participants in a seated position, the capture of USP signals will be done in 6 areas of each hemithorax as follows (SOUMMER et al., 2012): two anterior, two side and two back. In the evaluation of the pathological signs of USP, the investigators will search for B lines >2, coalescing B lines, and subpleural consolidations (MAFORT et al., 2021).
  measure: Functional Status scale PCFS
  time frame: October 2023
  description: The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19, being a self-administered questionnaire for the patient who will be informed: how much are you currently affected in your daily life by COVID 19? The patient will indicate in a classification from 0 to 4 their degree of functional status
  arm group label: Control
  description: This is a control group of individuals who were diagnosed with post-COVID-19 syndrome but did not underwent Physiotherapy.
  arm group label: Intervention
  description: This is an intervention group of individuals who were diagnosed with post-COVID-19 syndrome and underwent Physiotherapy
  intervention type: Other
  intervention name: Physiotherapy
  description: Physiotherapy in respiratory rehabilitation
  arm group label: Control
  arm group label: Intervention
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  country: Brazil
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  responsible party type: Sponsor
  mesh term: Post-Acute COVID-19 Syndrome