<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/NCT01667237</url>
  </required_header>
  <id_info>
    <org_study_id>20525</org_study_id>
    <nct_id>NCT01667237</nct_id>
  </id_info>
  <brief_title>Feasibility of a Short Home-based Rehabilitation Program for Cancer Patients Waiting for Lung Resection Surgery</brief_title>
  <official_title>Feasibility of a Short Home-based Rehabilitation Program for Cancer Patients Waiting for Lung Resection Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut universitaire de cardiologie et de pneumologie de Québec, University Laval</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The general objectives of this study are to verify the feasibility of a short home-based&#xD;
      rehabilitation program for cancer patients prior to lung resection surgery, and to quantify&#xD;
      its effects on aerobic capacity, exercise tolerance and skeletal muscle strength.&#xD;
&#xD;
      Therefore, the hypotheses of this study are that:&#xD;
&#xD;
        1. Implementation of a short home-based rehabilitation program (4 weeks) based on exercise&#xD;
           training is feasible and safe in patients with lung cancer resection candidates.&#xD;
&#xD;
        2. Compared to control patients, patients included in the home-based rehabilitation program&#xD;
           will improve significantly their aerobic capacity, exercise tolerance and arms and legs&#xD;
           muscle force.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Being the leading cause of death from cancer, lung cancer represents a pressing health issue&#xD;
      which generates significant social costs. In Canada, in 2009, an estimated 23 400 people will&#xD;
      be diagnosed with lung cancer, and 20 500 will die from the disease. For people with&#xD;
      localized non small cell lung cancer (NSCLC), lung resection surgery offers the best chance&#xD;
      of curing the disease. In addition with lung cancer, these patients often experience such&#xD;
      effects as a reduction in their exercise capacity and tolerance, muscle weakness, and&#xD;
      decreased quality of life. Many researches demonstrated a link between a low exercise&#xD;
      capacity and cardiopulmonary complications surrounding surgery. Therefore, the implementation&#xD;
      of a preoperative pulmonary rehabilitation program, focused on improving aerobic capacity,&#xD;
      could have significant positive outcomes, notably by reducing operative risks. The&#xD;
      effectiveness of pulmonary rehabilitation, whether carried-out in a supervised setting or as&#xD;
      a home-based program, is well recognized and such programs are included in guidelines for&#xD;
      many pulmonary diseases. Despite these facts, few researches have studied its impact on lung&#xD;
      cancer patients waiting for surgery. Moreover, not one have examined the feasibility and&#xD;
      effectiveness of a home-based program for this population.&#xD;
&#xD;
      We plan to use that time waiting for surgery to increase exercise capacity and work tolerance&#xD;
      of cancer patients waiting for surgery. Our expertise in pulmonary rehabilitation will prove&#xD;
      to be invaluable to carry out this research project which objectives are to verify the&#xD;
      feasibility of a short home-based rehabilitation program for cancer patients waiting for lung&#xD;
      resection surgery, and to measure its effects on aerobic capacity, work tolerance and muscle&#xD;
      strength.&#xD;
&#xD;
      In this way, we hope to contribute in developing innovative interventions that will assist&#xD;
      the Canadian Lung Association's mission of improving the health of patients with respiratory&#xD;
      problems. The results of this study will lead toward the development of a multicenter,&#xD;
      randomized study that will be designed to verify the impact of such interventions on&#xD;
      postoperative complications in this population.&#xD;
&#xD;
      Experimental design:&#xD;
&#xD;
      This pilot study will take place at the research center of the Institut de cardiologie et de&#xD;
      pneumologie de Québec (IUCPQ), in collaboration with the thoracic surgery division and the&#xD;
      Pavillon de Prevention des Maladies Cardiaques (PPMC). Once the lung cancer and surgical&#xD;
      procedure considered by pneumologist, we will obtain the patient's consent and we will&#xD;
      proceed to the initial assessment.&#xD;
&#xD;
      After the initial evaluation participants will undergo a 4-week home-based rehabilitation&#xD;
      program under the supervision of an exercise specialist certified by the American College of&#xD;
      Sport Medicine. Patients will be reevaluated after 4 weeks.&#xD;
&#xD;
      Preliminary screening: An initial screening, including maximal oxygen consumption assessment,&#xD;
      will be performed under the supervision of a respiratory physician (Dr F. Maltais) to ensure&#xD;
      that patients meet the all the inclusion and exclusion criteria of the study. In addition, a&#xD;
      brief history of each patient's disease course and medication will be recorded.&#xD;
&#xD;
      Anthropometric measurements: Weight and height will be measured to determine the Body Mass&#xD;
      Index (BMI). Body composition will be analyzed by bio-impedance (InBody 520, Biospace).&#xD;
&#xD;
      Quality of life and psychological distress: Generic quality-of-life questionnaires provide&#xD;
      information on many aspects of a patient's life and can also be used to discriminate between&#xD;
      patients within the same population. However, they are not as responsive to change as&#xD;
      disease-specific questionnaires. Thus, generic quality-of-life assessment will be obtained at&#xD;
      the time of enrolment. The SF-36 survey was selected for its ease of administration and&#xD;
      because it is the most largely used questionnaire. A French version of the SF-36 is currently&#xD;
      available. These data will be obtained only for descriptive analyses.&#xD;
&#xD;
      Pulmonary function tests: Standard pulmonary function tests including spirometry, lung&#xD;
      volumes, and carbon monoxide diffusion capacity will be obtained for all subjects during the&#xD;
      initial evaluation, according to previously described guidelines, and related to appropriate&#xD;
      reference values.&#xD;
&#xD;
      Incremental cycle exercise test: In order to determine peak aerobic capacity and eligibility,&#xD;
      and to quantify changes in exercise tolerance occurring with exercise training, an&#xD;
      incremental exercise test will be performed (before inclusion). Patients will be seated on an&#xD;
      electrically braked ergocycle (Quinton Corival 400; A-H Robins, Seattle, WA) and connected to&#xD;
      the exercise circuit through a mouthpiece (Sensor Medics, Vpeak Legacy, Yorba Linda, CA). A&#xD;
      progressive stepwise exercise test will be performed up to individual's peakimum capacity,&#xD;
      using exercise steps of 1 minute and increments of 5-10 watts. Heart rate and oxygen&#xD;
      saturation will be recorded using pulse oximetry and ECG, respectively. Symptoms of dyspnea&#xD;
      and leg fatigue will be recorded using a modified Borg scale for perceived exertion52.&#xD;
      Testing will take place under medical supervision, in the exercise physiology laboratory of&#xD;
      IUCPQ research center.&#xD;
&#xD;
      Constant workrate cycle exercise test and 6-min walking test: A constant workrate cycle&#xD;
      exercise test and a 6-min walking test will be performed to quantify changes in exercise&#xD;
      tolerance occurring with exercise training.&#xD;
&#xD;
        1. During the constant workrate cycle exercise test, patients will be asked to pedal at 80%&#xD;
           max exercise work rate determined during the maximal test, and the time to exhaustion&#xD;
           will be measured. Heart rate, dyspnea Borg score, and oxygen saturation will be&#xD;
           monitored. Supplemental oxygen will be used if oxygen saturation &lt; 90%.&#xD;
&#xD;
        2. For the 6-min walking test, patients will also be asked to walk as far as possible for 6&#xD;
           minutes with standardized encouragement53. Two trials will be done and only the best one&#xD;
           will be used for data analysis. Monitoring of respiratory and cardiac parameters, in&#xD;
           addition to dyspnea and leg fatigue (modified Borg scale) will be done during the test.&#xD;
&#xD;
      Strength evaluation:&#xD;
&#xD;
        1. Quadriceps strength will be assessed in two ways. First, by maximum voluntary&#xD;
           contraction, and second, by measuring supramaximal twitch tension from a series of&#xD;
           twitch following a magnetic stimulation (Magstim 200; Magstim Co.) of the femoral nerve&#xD;
           as previously described. Generated force will be measured by an isometric force gauge&#xD;
           while subjects will be in a standardized positioning. Validity and sensitivity of this&#xD;
           equipment have previously been studied and we have used it in previous studies.&#xD;
&#xD;
        2. Maximum voluntary contraction of the biceps brachii, deltoid and hamstring will be&#xD;
           measured with a hand-held dynamometer (Microfet. Hoggan Inc, USA), using the method&#xD;
           described and validated by Andrews and colleagues56. Finally, a maximum prehension&#xD;
           strength will be assessed with a hydraulic dynamometer (Jamar).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To verify the feasability of a short home-based rehabilitation for cancer patients prior to lung resection surgery program.</measure>
    <time_frame>During a 4 week rehabilitation programs preceeding surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To quantify the cycle endurance change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program.</measure>
    <time_frame>before and after a 4 week rehabilitation programs preceeding surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To quantify the quadriceps muscle force change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program.</measure>
    <time_frame>before and after a 4 week rehabilitation programs preceeding surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Pulmonary rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home-based pulmonary rehabilitation program</intervention_name>
    <description>The rehabilitation program will be a self-monitored and minimally supervised home-exercise program. Exercise training modalities and intensity will be adapted to patient's individual condition. It will include aerobic and strength exercises 5 times a week for 4 weeks. Aerobic training will be done on a portable ergocycle. The target intensity will correspond to 60% of the maximal work rate achieved during the maximal progressive cardio-pulmonary exercise test, aiming for a cumulative time of 40 minutes per day. The heart rate, corresponding to an exercise level of 60% of max exercise capacity during the maximum exercise test, will be noted and patients will be instructed to train at this heart rate ± 10 beats. Muscle exercises will be performed using elastic bands and use of gravity.</description>
    <arm_group_label>Pulmonary rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suffering from a non-small cell lung cancer on a waiting list for lung resection&#xD;
&#xD;
          -  Having a VO2 Peak value of less than 20mL/kg/min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  SaO2 less less than 80% during the cardiopulmonary exercise test&#xD;
&#xD;
          -  Contraindications to exercise testing (per American Thoracic Society/American College&#xD;
             of Chest Physicians Exercise Testing Guidelines)&#xD;
&#xD;
          -  A history of significant or cardiovascular disease, hypertension, diabetes, or&#xD;
             musculoskeletal concerns that might limit the ability of these subjects to perform&#xD;
             active exercises&#xD;
&#xD;
          -  Severe psychiatric illness compromising training rehabilitation observance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Didier Saey, Phd.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut universitaire de cardiologie et de pneumologie de Québec, University Laval</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRIUCPQ</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>July 1, 2010</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>January 9, 2013</last_update_submitted>
  <last_update_submitted_qc>January 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec</investigator_affiliation>
    <investigator_full_name>Didier Saey</investigator_full_name>
    <investigator_title>Adjunct professor</investigator_title>
  </responsible_party>
  <keyword>Pulmonary rehabilitation program</keyword>
  <keyword>Lung cancer</keyword>
  <keyword>Lung resection surgery</keyword>
  <keyword>Home-based</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01667237
org study id: 20525
nct id: NCT01667237
lead sponsor: 
has dmc: Yes
The general objectives of this study are to verify the feasibility of a short home-based
      rehabilitation program for cancer patients prior to lung resection surgery, and to quantify
      its effects on aerobic capacity, exercise tolerance and skeletal muscle strength.

      Therefore, the hypotheses of this study are that:

        1. Implementation of a short home-based rehabilitation program (4 weeks) based on exercise
           training is feasible and safe in patients with lung cancer resection candidates.

        2. Compared to control patients, patients included in the home-based rehabilitation program
           will improve significantly their aerobic capacity, exercise tolerance and arms and legs
           muscle force.
Being the leading cause of death from cancer, lung cancer represents a pressing health issue
      which generates significant social costs. In Canada, in 2009, an estimated 23 400 people will
      be diagnosed with lung cancer, and 20 500 will die from the disease. For people with
      localized non small cell lung cancer (NSCLC), lung resection surgery offers the best chance
      of curing the disease. In addition with lung cancer, these patients often experience such
      effects as a reduction in their exercise capacity and tolerance, muscle weakness, and
      decreased quality of life. Many researches demonstrated a link between a low exercise
      capacity and cardiopulmonary complications surrounding surgery. Therefore, the implementation
      of a preoperative pulmonary rehabilitation program, focused on improving aerobic capacity,
      could have significant positive outcomes, notably by reducing operative risks. The
      effectiveness of pulmonary rehabilitation, whether carried-out in a supervised setting or as
      a home-based program, is well recognized and such programs are included in guidelines for
      many pulmonary diseases. Despite these facts, few researches have studied its impact on lung
      cancer patients waiting for surgery. Moreover, not one have examined the feasibility and
      effectiveness of a home-based program for this population.

      We plan to use that time waiting for surgery to increase exercise capacity and work tolerance
      of cancer patients waiting for surgery. Our expertise in pulmonary rehabilitation will prove
      to be invaluable to carry out this research project which objectives are to verify the
      feasibility of a short home-based rehabilitation program for cancer patients waiting for lung
      resection surgery, and to measure its effects on aerobic capacity, work tolerance and muscle
      strength.

      In this way, we hope to contribute in developing innovative interventions that will assist
      the Canadian Lung Association's mission of improving the health of patients with respiratory
      problems. The results of this study will lead toward the development of a multicenter,
      randomized study that will be designed to verify the impact of such interventions on
      postoperative complications in this population.

      Experimental design:

      This pilot study will take place at the research center of the Institut de cardiologie et de
      pneumologie de Québec (IUCPQ), in collaboration with the thoracic surgery division and the
      Pavillon de Prevention des Maladies Cardiaques (PPMC). Once the lung cancer and surgical
      procedure considered by pneumologist, we will obtain the patient's consent and we will
      proceed to the initial assessment.

      After the initial evaluation participants will undergo a 4-week home-based rehabilitation
      program under the supervision of an exercise specialist certified by the American College of
      Sport Medicine. Patients will be reevaluated after 4 weeks.

      Preliminary screening: An initial screening, including maximal oxygen consumption assessment,
      will be performed under the supervision of a respiratory physician (Dr F. Maltais) to ensure
      that patients meet the all the inclusion and exclusion criteria of the study. In addition, a
      brief history of each patient's disease course and medication will be recorded.

      Anthropometric measurements: Weight and height will be measured to determine the Body Mass
      Index (BMI). Body composition will be analyzed by bio-impedance (InBody 520, Biospace).

      Quality of life and psychological distress: Generic quality-of-life questionnaires provide
      information on many aspects of a patient's life and can also be used to discriminate between
      patients within the same population. However, they are not as responsive to change as
      disease-specific questionnaires. Thus, generic quality-of-life assessment will be obtained at
      the time of enrolment. The SF-36 survey was selected for its ease of administration and
      because it is the most largely used questionnaire. A French version of the SF-36 is currently
      available. These data will be obtained only for descriptive analyses.

      Pulmonary function tests: Standard pulmonary function tests including spirometry, lung
      volumes, and carbon monoxide diffusion capacity will be obtained for all subjects during the
      initial evaluation, according to previously described guidelines, and related to appropriate
      reference values.

      Incremental cycle exercise test: In order to determine peak aerobic capacity and eligibility,
      and to quantify changes in exercise tolerance occurring with exercise training, an
      incremental exercise test will be performed (before inclusion). Patients will be seated on an
      electrically braked ergocycle (Quinton Corival 400; A-H Robins, Seattle, WA) and connected to
      the exercise circuit through a mouthpiece (Sensor Medics, Vpeak Legacy, Yorba Linda, CA). A
      progressive stepwise exercise test will be performed up to individual's peakimum capacity,
      using exercise steps of 1 minute and increments of 5-10 watts. Heart rate and oxygen
      saturation will be recorded using pulse oximetry and ECG, respectively. Symptoms of dyspnea
      and leg fatigue will be recorded using a modified Borg scale for perceived exertion52.
      Testing will take place under medical supervision, in the exercise physiology laboratory of
      IUCPQ research center.

      Constant workrate cycle exercise test and 6-min walking test: A constant workrate cycle
      exercise test and a 6-min walking test will be performed to quantify changes in exercise
      tolerance occurring with exercise training.

        1. During the constant workrate cycle exercise test, patients will be asked to pedal at 80%
           max exercise work rate determined during the maximal test, and the time to exhaustion
           will be measured. Heart rate, dyspnea Borg score, and oxygen saturation will be
           monitored. Supplemental oxygen will be used if oxygen saturation < 90%.

        2. For the 6-min walking test, patients will also be asked to walk as far as possible for 6
           minutes with standardized encouragement53. Two trials will be done and only the best one
           will be used for data analysis. Monitoring of respiratory and cardiac parameters, in
           addition to dyspnea and leg fatigue (modified Borg scale) will be done during the test.

      Strength evaluation:

        1. Quadriceps strength will be assessed in two ways. First, by maximum voluntary
           contraction, and second, by measuring supramaximal twitch tension from a series of
           twitch following a magnetic stimulation (Magstim 200; Magstim Co.) of the femoral nerve
           as previously described. Generated force will be measured by an isometric force gauge
           while subjects will be in a standardized positioning. Validity and sensitivity of this
           equipment have previously been studied and we have used it in previous studies.

        2. Maximum voluntary contraction of the biceps brachii, deltoid and hamstring will be
           measured with a hand-held dynamometer (Microfet. Hoggan Inc, USA), using the method
           described and validated by Andrews and colleagues56. Finally, a maximum prehension
           strength will be assessed with a hydraulic dynamometer (Jamar).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: To verify the feasability of a short home-based rehabilitation for cancer patients prior to lung resection surgery program.
time frame: During a 4 week rehabilitation programs preceeding surgery
measure: To quantify the cycle endurance change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program.
time frame: before and after a 4 week rehabilitation programs preceeding surgery
measure: To quantify the quadriceps muscle force change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program.
time frame: before and after a 4 week rehabilitation programs preceeding surgery
arm group label: Pulmonary rehabilitation
arm group type: Experimental
intervention type: Behavioral
intervention name: Home-based pulmonary rehabilitation program
description: The rehabilitation program will be a self-monitored and minimally supervised home-exercise program. Exercise training modalities and intensity will be adapted to patient's individual condition. It will include aerobic and strength exercises 5 times a week for 4 weeks. Aerobic training will be done on a portable ergocycle. The target intensity will correspond to 60% of the maximal work rate achieved during the maximal progressive cardio-pulmonary exercise test, aiming for a cumulative time of 40 minutes per day. The heart rate, corresponding to an exercise level of 60% of max exercise capacity during the maximum exercise test, will be noted and patients will be instructed to train at this heart rate ± 10 beats. Muscle exercises will be performed using elastic bands and use of gravity.
arm group label: Pulmonary rehabilitation
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Didier Saey, Phd.
role: Principal Investigator
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
investigator full name: Didier Saey
investigator title: Adjunct professor
mesh term: Lung Neoplasms