<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/NCT03020251</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A00622-49</org_study_id>
    <nct_id>NCT03020251</nct_id>
  </id_info>
  <brief_title>Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer</brief_title>
  <acronym>Rexochir</acronym>
  <official_title>Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Jean Perrin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Jean Perrin</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>
      This randomized controlled trial will evaluate the effect of a preoperative rehabilitation&#xD;
      program at home in patients resected for lung cancer, comparing a control group (C group)&#xD;
      receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a&#xD;
      training program at home and chest physiotherapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 12, 2017</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2025</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital length of stay after resection for lung cancer</measure>
    <time_frame>time from the date of the surgery (Day 0) until the date of discharge (Day n) (assessed up to 56 days)</time_frame>
    <description>the date of discharge will be the real day of discharge from surgery department or the day where the patient will be medically considered as outgoing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the number of complications</measure>
    <time_frame>during the stay in the surgery department or the intensive care unit (up to 56 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peak oxygen consumption</measure>
    <time_frame>evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)</time_frame>
    <description>evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).&#xD;
evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 minutes walking distance</measure>
    <time_frame>evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)</time_frame>
    <description>evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).&#xD;
evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal voluntary quadriceps strength</measure>
    <time_frame>evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)</time_frame>
    <description>evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).&#xD;
evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal inspiratory and expiratory strength</measure>
    <time_frame>evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)</time_frame>
    <description>evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).&#xD;
evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>real length of stay</measure>
    <time_frame>between the first postoperative day (Day 1) and the real discharge date (up to 56 days)</time_frame>
    <description>the real day of discharge from surgery department</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body composition (bioimpedancemetry)</measure>
    <time_frame>evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)</time_frame>
    <description>evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).&#xD;
evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxidative adaptations of the muscle</measure>
    <time_frame>evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2 after intervention : at the date of surgery (during the surgical time at Day 0 week 6)</time_frame>
    <description>optional ancillary study on quadricipal and intercostal muscle biopsies.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Lungcancer</condition>
  <arm_group>
    <arm_group_label>control group (C group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient will receive preoperative chest physiotherapy (standard supportive care)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rehabilitation group (R group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>preoperative chest physiotherapy</intervention_name>
    <description>preoperative chest physiotherapy : 5 sessions per week during 3 weeks</description>
    <arm_group_label>control group (C group)</arm_group_label>
    <arm_group_label>rehabilitation group (R group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>preoperative rehabilitation program</intervention_name>
    <description>exercise training at home : 5 sessions per week during 3 weeks</description>
    <arm_group_label>rehabilitation group (R group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed for lung cancer (or highly suspicious for cancer tumor) eligible&#xD;
             for resection surgery (lobectomy or pneumonectomy)&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Presence of Chronic Obstructive Pulmonary Disease (COPD) stages 2-4 of Gold (forced&#xD;
             expiratory volume (FEV )/ forced vital capacity (FVC) &lt;70%, FEV &lt;80% of predicted) and&#xD;
             Exertional dyspnea stage MMRC (Medical Research Council) &gt; 1&#xD;
&#xD;
          -  Patients must provide written consent&#xD;
&#xD;
          -  Member of social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refusing to participate&#xD;
&#xD;
          -  COPD stage 1 Gold (VEMS &gt;= 80% of the theoretical value)&#xD;
&#xD;
          -  Presenting an operating contraindication during the initial maximal exercise test&#xD;
&#xD;
          -  Presenting cardiac or vascular contraindication to achieve the readaptation program&#xD;
&#xD;
          -  Patient living alone at home&#xD;
&#xD;
          -  Patient with ventilatory assistance at home (oxygen therapy or noninvasive ventilation&#xD;
             (NIV))&#xD;
&#xD;
          -  With exercise hypoventilation (PaCO2 &gt;45 mmHg)&#xD;
&#xD;
          -  Cognitive difficulty&#xD;
&#xD;
          -  unable major&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  patients deprived of liberty by a court or administrative decision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc FILAIRE, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Jean Perrin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marc FILAIRE, Pr</last_name>
    <phone>33473278121</phone>
    <email>marc.filaire@clermont.unicancer.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Clermont Ferrand, Gabriel Montpied, service de médecine du sport et explorations fonctionnelles,</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Frédéric Coste, MD</last_name>
    </contact>
    <investigator>
      <last_name>Frédéric Costes</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche en Nutrition Humaine</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ruddy Richard, Pr</last_name>
    </contact>
    <investigator>
      <last_name>Ruddy Richard, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc Filaire, Pr</last_name>
      <phone>33 (0) 4 73 27 53 11</phone>
      <email>marc.filaire@cjp.fr</email>
    </contact>
    <investigator>
      <last_name>Marc Filaire, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble, Hôpital Michallon</name>
      <address>
        <city>Grenoble</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yves Brichon, Pr</last_name>
    </contact>
    <investigator>
      <last_name>Yves Brichon, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospices Civiles de Lyon, groupement hospitalier Est, Hopital Louis Pradel</name>
      <address>
        <city>Lyon</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>François Tronc, Pr</last_name>
    </contact>
    <investigator>
      <last_name>François Tronc, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Etienne, CHU Hopital Nord</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Olivier Tiffet, Pr</last_name>
    </contact>
    <investigator>
      <last_name>Olivier Tiffet, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>preoperative rehabilitation program</keyword>
  <keyword>chest physiotherapy</keyword>
  <keyword>lung cancer resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung 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/NCT03020251
org study id: 2016-A00622-49
nct id: NCT03020251
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial will evaluate the effect of a preoperative rehabilitation
      program at home in patients resected for lung cancer, comparing a control group (C group)
      receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a
      training program at home and chest physiotherapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Hospital length of stay after resection for lung cancer
time frame: time from the date of the surgery (Day 0) until the date of discharge (Day n) (assessed up to 56 days)
description: the date of discharge will be the real day of discharge from surgery department or the day where the patient will be medically considered as outgoing
measure: the number of complications
time frame: during the stay in the surgery department or the intensive care unit (up to 56 days)
measure: peak oxygen consumption
time frame: evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)
description: evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).
evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
measure: 6 minutes walking distance
time frame: evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)
description: evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).
evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
measure: maximal voluntary quadriceps strength
time frame: evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)
description: evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).
evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
measure: maximal inspiratory and expiratory strength
time frame: evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)
description: evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).
evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
measure: real length of stay
time frame: between the first postoperative day (Day 1) and the real discharge date (up to 56 days)
description: the real day of discharge from surgery department
measure: body composition (bioimpedancemetry)
time frame: evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)
description: evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).
evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
measure: oxidative adaptations of the muscle
time frame: evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2 after intervention : at the date of surgery (during the surgical time at Day 0 week 6)
description: optional ancillary study on quadricipal and intercostal muscle biopsies.
arm group label: control group (C group)
arm group type: Active Comparator
description: patient will receive preoperative chest physiotherapy (standard supportive care)
arm group label: rehabilitation group (R group)
arm group type: Experimental
description: patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)
intervention type: Other
intervention name: preoperative chest physiotherapy
description: preoperative chest physiotherapy : 5 sessions per week during 3 weeks
arm group label: control group (C group)
arm group label: rehabilitation group (R group)
intervention type: Other
intervention name: preoperative rehabilitation program
description: exercise training at home : 5 sessions per week during 3 weeks
arm group label: rehabilitation group (R group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc FILAIRE, Pr
role: Principal Investigator
affiliation: Centre Jean Perrin
last name: Marc FILAIRE, Pr
phone: 33473278121
email: marc.filaire@clermont.unicancer.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No