<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/NCT01666158</url>
  </required_header>
  <id_info>
    <org_study_id>12-171-SDR</org_study_id>
    <nct_id>NCT01666158</nct_id>
  </id_info>
  <brief_title>Prehabilitation for Esophageal Resection Surgery</brief_title>
  <official_title>Prehabilitation to Enhance Postoperative Functional Capacity Following Esophageal Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Franco Carli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Consenting patients scheduled for esophageal resection surgery will be randomized to receive&#xD;
      standard nutrition counseling (including nutritional supplements as needed) or standard&#xD;
      nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery.&#xD;
&#xD;
      It is hypothesized that, compared with the group receiving nutrition alone, the addition of&#xD;
      physical exercise to nutrition starting before surgery and continuing for 8 weeks after&#xD;
      surgery will have a significantly greater impact on functional walking capacity during the&#xD;
      prehabilitation period and during the postoperative period, and on the incidence of&#xD;
      postoperative pulmonary complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled study in patients undergoing esophageal resection for cancer to&#xD;
      determine the impact of multimodal prehabilitation on functional exercise capacity and&#xD;
      postoperative pulmonary complications. Patients who accept to be enrolled in the study will&#xD;
      be randomized to receive either a standard nutritional intervention (including supplements as&#xD;
      needed) as per current institution policy or standard nutritional intervention (including&#xD;
      supplements as needed) combined with a physical exercise program before and after surgery.&#xD;
&#xD;
      Specific aims&#xD;
&#xD;
      The aims of this research project are the following:&#xD;
&#xD;
        1. To determine the extent in which a multimodal prehabilitation regimen optimizes&#xD;
           functional recovery in patients suffering from esophageal cancer and the incidence of&#xD;
           postoperative pulmonary complications.&#xD;
&#xD;
        2. To understand further which measures of immediate surgical recovery are sensitive to&#xD;
           prehabilitation interventions, and predict change in later outcome measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 minute walk test (6MWT)</measure>
    <time_frame>up to 8 weeks after surgery</time_frame>
    <description>The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Esophageal Cancer</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will follow standard MUHC protocol of nutritional counseling and supplementation as needed in order to maintain caloric and protein requirements in the preoperative period. Additionally, these patients will be given a specific physical exercise program before and after surgery by kinesiologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard nutrition counselling</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this group will follow standard MUHC protocol of nutritional counseling and supplementation as needed in order to maintain caloric and protein requirements in the preoperative period. This group will receive general instructions on exercises (breathing, ankle rotation) to be done during hospital stay by kinesiologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>The exercise component will consist of 20 min of general exercise training, 3 days per week, alternating between aerobic and resistance training. The exercise program will be individualized based upon the baseline fitness test (according to the American College of Sport Medicine, ACMS, standard) and will include: a 5 min warm-up, either 25 min of aerobic exercise (starting at 30- 40 of heart rate reserve, HRR), or 25 min of resistance training (5 exercises targeting major muscle groups performed at an intensity of 8-12 repetition maximum), and a 5 min cool-down.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 and older&#xD;
&#xD;
          -  referred electively for resection of malignant esophageal lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) health status class 4-5&#xD;
&#xD;
          -  Dementia and psychosis&#xD;
&#xD;
          -  Disabling orthopedic and neuromuscular disease&#xD;
&#xD;
          -  Severe cardiac abnormalities&#xD;
&#xD;
          -  Severe end-organ disease such as cardiac failure (New York Heart Association classes&#xD;
             I-IV)&#xD;
&#xD;
          -  COPD&#xD;
&#xD;
          -  renal failure (creatinine &gt; 1.5 mg/dl, and hepatic failure ALT and AST &gt;50% over the&#xD;
             normal range)&#xD;
&#xD;
          -  Morbid obesity (BMI &gt;30)&#xD;
&#xD;
          -  Anemia (hematocrit &lt; 30 %, haemoglobin &lt;10g/dl, albumin &lt; 25mg/dl)&#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>Franco Carli, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montreal University Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montreal General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.</citation>
    <PMID>21878237</PMID>
  </results_reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>March 20, 2018</last_update_submitted>
  <last_update_submitted_qc>March 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Franco Carli</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01666158
org study id: 12-171-SDR
nct id: NCT01666158
lead sponsor: 
has dmc: Yes
Consenting patients scheduled for esophageal resection surgery will be randomized to receive
      standard nutrition counseling (including nutritional supplements as needed) or standard
      nutrition counseling and exercise 4 weeks before surgery and 8 weeks after surgery.

      It is hypothesized that, compared with the group receiving nutrition alone, the addition of
      physical exercise to nutrition starting before surgery and continuing for 8 weeks after
      surgery will have a significantly greater impact on functional walking capacity during the
      prehabilitation period and during the postoperative period, and on the incidence of
      postoperative pulmonary complications.
A randomized controlled study in patients undergoing esophageal resection for cancer to
      determine the impact of multimodal prehabilitation on functional exercise capacity and
      postoperative pulmonary complications. Patients who accept to be enrolled in the study will
      be randomized to receive either a standard nutritional intervention (including supplements as
      needed) as per current institution policy or standard nutritional intervention (including
      supplements as needed) combined with a physical exercise program before and after surgery.

      Specific aims

      The aims of this research project are the following:

        1. To determine the extent in which a multimodal prehabilitation regimen optimizes
           functional recovery in patients suffering from esophageal cancer and the incidence of
           postoperative pulmonary complications.

        2. To understand further which measures of immediate surgical recovery are sensitive to
           prehabilitation interventions, and predict change in later outcome measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: 6 minute walk test (6MWT)
time frame: up to 8 weeks after surgery
description: The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.
arm group label: Exercise
arm group type: Active Comparator
description: Patients in this group will follow standard MUHC protocol of nutritional counseling and supplementation as needed in order to maintain caloric and protein requirements in the preoperative period. Additionally, these patients will be given a specific physical exercise program before and after surgery by kinesiologist.
arm group label: Standard nutrition counselling
arm group type: No Intervention
description: Patients in this group will follow standard MUHC protocol of nutritional counseling and supplementation as needed in order to maintain caloric and protein requirements in the preoperative period. This group will receive general instructions on exercises (breathing, ankle rotation) to be done during hospital stay by kinesiologist.
intervention type: Behavioral
intervention name: Exercise
description: The exercise component will consist of 20 min of general exercise training, 3 days per week, alternating between aerobic and resistance training. The exercise program will be individualized based upon the baseline fitness test (according to the American College of Sport Medicine, ACMS, standard) and will include: a 5 min warm-up, either 25 min of aerobic exercise (starting at 30- 40 of heart rate reserve, HRR), or 25 min of resistance training (5 exercises targeting major muscle groups performed at an intensity of 8-12 repetition maximum), and a 5 min cool-down.
arm group label: Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Franco Carli, M.D.
role: Principal Investigator
affiliation: Montreal University Health Centre
facility: 
country: Canada
citation: Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.
PMID: 21878237
responsible party type: Sponsor-Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Franco Carli
investigator title: Professor