<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/NCT03824977</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A02694-51</org_study_id>
    <nct_id>NCT03824977</nct_id>
  </id_info>
  <brief_title>Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery</brief_title>
  <acronym>PREOTEST</acronym>
  <official_title>Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</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>
      The objective of this study is to evaluate the performances of the Six-Minute Stepper Test&#xD;
      (6MST) and Sit To Stand test (STST) to predict post-operative complications after minimally&#xD;
      invasive lung cancer resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2018</start_date>
  <completion_date type="Actual">February 4, 2020</completion_date>
  <primary_completion_date type="Actual">February 4, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Months</target_duration>
  <primary_outcome>
    <measure>occurrence of a post-operative complication grade ≥ 2 on the Clavien-Dindo scale within three months after surgery</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <enrollment type="Actual">122</enrollment>
  <condition>Lung Neoplasm Malignant</condition>
  <condition>Resectable Lung Non-Small Cell Carcinoma</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Six minutes stepper test (6MST)</intervention_name>
    <description>The 6MST is done using a stepper (Stepper essential, Decathlon(TM), France), with a walking height of 20 cm, placed in front of a wall or parallel bars, so patients can hold on if necessary.&#xD;
Patients are instructed to make the maximum number of steps possible in 6 minutes, and are given a time check at one minute intervals.</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sit to stand test (STST)</intervention_name>
    <description>The STST is done using a chair measuring 47 cm in height. The patient are instructed to sit in the chair and then to do the maximum number of lifts possible from the chair, in 1 minute, with arms folded and without leaning against the chair.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients are included. On the day of the surgical consultation, the patient is&#xD;
        informed of the modalities of the study by the thoracic surgeon and collects his&#xD;
        non-opposition of participation. He is also evaluated by a physiotherapist, who supervises&#xD;
        the realization of 6MST and STST.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18&#xD;
&#xD;
          -  Non-small cell lung cancer stage I to II, justifying major resection by VATS or RATS&#xD;
             (segmentectomy, lobectomy, pneumonectomy), with or without histological confirmation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Partial or total amputation localized to the lower limb;&#xD;
&#xD;
          -  Weight greater than 100 kg;&#xD;
&#xD;
          -  Orthopedic, vascular or neurological disorders leading to the incapacity of realize&#xD;
             the 6MST;&#xD;
&#xD;
          -  Patient under tutorship or curatorship;&#xD;
&#xD;
          -  Pregnant woman.&#xD;
&#xD;
          -  Surgery canceled&#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>Boujibar , F</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>February 18, 2022</last_update_submitted>
  <last_update_submitted_qc>February 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lung resection</keyword>
  <keyword>low technology</keyword>
  <keyword>six minutes stepper test</keyword>
  <keyword>sit to stand test</keyword>
  <keyword>physiotherapy</keyword>
  <keyword>lung surgery</keyword>
  <keyword>post-operative complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03824977
org study id: 2018-A02694-51
nct id: NCT03824977
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate the performances of the Six-Minute Stepper Test
      (6MST) and Sit To Stand test (STST) to predict post-operative complications after minimally
      invasive lung cancer resection.
observational model: Cohort
time perspective: Prospective
measure: occurrence of a post-operative complication grade ≥ 2 on the Clavien-Dindo scale within three months after surgery
time frame: 90 days
intervention type: Diagnostic Test
intervention name: Six minutes stepper test (6MST)
description: The 6MST is done using a stepper (Stepper essential, Decathlon(TM), France), with a walking height of 20 cm, placed in front of a wall or parallel bars, so patients can hold on if necessary.
Patients are instructed to make the maximum number of steps possible in 6 minutes, and are given a time check at one minute intervals.
intervention type: Diagnostic Test
intervention name: Sit to stand test (STST)
description: The STST is done using a chair measuring 47 cm in height. The patient are instructed to sit in the chair and then to do the maximum number of lifts possible from the chair, in 1 minute, with arms folded and without leaning against the chair.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Lung Neoplasms
mesh term: Neoplasms
sharing ipd: No