<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/NCT03244137</url>
  </required_header>
  <id_info>
    <org_study_id>PR-COPD</org_study_id>
    <nct_id>NCT03244137</nct_id>
  </id_info>
  <brief_title>Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ADIR Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CHU de Rouen - Accueil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Groupe Hospitalier du Havre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ADIR Association</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>
      Chronic obstructive pulmonary disease is a leading cause of mortality worldwide.&#xD;
&#xD;
      It is a systemic disease which includes pulmonary, cardiac, muscular, digestive and cognitive&#xD;
      impairments.&#xD;
&#xD;
      Pulmonary rehabilitation is a symptomatic treatment to reduce dyspnea and functional&#xD;
      incapacity. However, it effects on cognitive dysfunction are not well known.&#xD;
&#xD;
      The aim of this study is to assess the effects of a comprehensive pulmonary rehabilitation&#xD;
      program on cognitive dysfunction in patients with severe to very severe chronic obstructive&#xD;
      pulmonary disease using the Montreal Cognitive Assessment tool.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Baseline cognitive function</measure>
    <time_frame>Cognitive function is assessed at the beginning of the rehabilitation program : day 0</time_frame>
    <description>Cognitive function is assessed with the Montreal Cognitive Assessement tool</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive function after pulmonary rehabilitation</measure>
    <time_frame>Cognitive function is assessed at the end of the rehabilitation program : day 60</time_frame>
    <description>Cognitive function is assessed with the Montreal Cognitive Assessement tool</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive function : follow up</measure>
    <time_frame>Cognitive function is assessed 3 month after rehabilitation : day 150</time_frame>
    <description>Cognitive function is assessed with the Montreal Cognitive Assessement tool</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cognitive function from baseline to the end of pulmonary rehabilitation</measure>
    <time_frame>Change in cognitive function from baseline to the end of pulmonary rehabilitation is assessed with end of pulmonary rehabilitation minus baseline values (day 60 - day 0)</time_frame>
    <description>Cognitive function is assessed with the Montreal Cognitive Assessement tool</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up</measure>
    <time_frame>Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up is assessed with the 3 month of follow minus the end of pulmonary rehabilitation values (day 150 - day 60)</time_frame>
    <description>Cognitive function is assessed with the Montreal Cognitive Assessement tool</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression : baseline</measure>
    <time_frame>Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0</time_frame>
    <description>Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression : end of pulmonary rehabilitation</measure>
    <time_frame>Anxiety and depression are assessed at the end of the rehabilitation program : day 60</time_frame>
    <description>Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression : follow up</measure>
    <time_frame>Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150</time_frame>
    <description>Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life : baseline</measure>
    <time_frame>Quality of life is assessed at the beginning of the rehabilitation program : day 0</time_frame>
    <description>Quality of life is assessed using the Saint Georges Respiratory Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life : end of pulmonary rehabilitation</measure>
    <time_frame>Quality of life is assessed at the end of the rehabilitation program : day 60</time_frame>
    <description>Quality of life is assessed using the Saint Georges Respiratory Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life : follow-up</measure>
    <time_frame>Quality of life is assessed 3 month after the end of the rehabilitation program : day 150</time_frame>
    <description>Quality of life is assessed using the Saint Georges Respiratory Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity (six-minute stepper test) : baseline</measure>
    <time_frame>Functional capacity is assessed at the beginning of the rehabilitation program : day 0</time_frame>
    <description>Functional capacity is assessed with the six-minute stepper test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity (six-minute stepper test) : end of pulmonary rehabilitation</measure>
    <time_frame>Functional capacity is assessed at the end of the rehabilitation program : day 60</time_frame>
    <description>Functional capacity is assessed with the six-minute stepper test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity (six-minute walk test) : baseline</measure>
    <time_frame>Functional capacity is assessed at the beginning of the rehabilitation program : day 0</time_frame>
    <description>Functional capacity is assessed with the six-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>Adherence is assessed at the end of the rehabilitation program : day 60</time_frame>
    <description>Adherence to the pulmonary rehabilitation program is assessed by the following equation : number of session performed divided by the number of scheduled sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between the cognitive function and the respiratory function (forced expiratory volume in 1 second)</measure>
    <time_frame>The relation is assessed between baseline demographic data at day 0</time_frame>
    <description>Cognitive function is assessed with the Montreal Cognitive Assessement tool and respiratory function is assessed with spirometric evaluation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">56</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Pulmonary rehabilitation</arm_group_label>
    <description>The whole population will benefit from a comprehensive pulmonary rehabilitation program, including aerobic training, superior and inferior limb strength training, self-management and add-on to pulmonary rehabilitation as needed (i.e : electrical muscle stimulation, inspiratory muscle training, non-invasive ventilation, high flow nasal canula).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pulmonary rehabilitation</intervention_name>
    <description>See group description.</description>
    <arm_group_label>Pulmonary rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Every patients with chronic obstructive pulmonary disease referred for pulmonary&#xD;
        rehabilitation in ADIR Association (Rouen, France) and the Groupe Hospitalier du Havre (Le&#xD;
        Havre, France) will be assessed for eligibility.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18years;&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease stade III to IV;&#xD;
&#xD;
          -  Referred for pulmonary rehabilitation.&#xD;
&#xD;
        Non Inclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or likely to be;&#xD;
&#xD;
          -  History of psychiatric, neuro-vascular, cognitive disease or cranial trauma;&#xD;
&#xD;
          -  Active alcoholism;&#xD;
&#xD;
          -  Guardianship;&#xD;
&#xD;
          -  Hospitalisation for acute exacerbation of chronic obstructive pulmonary disease in the&#xD;
             previous 4 weeks;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Interruption of the pulmonary rehabilitation program &gt; 15 days;&#xD;
&#xD;
          -  Disruption of the training before the 18th session;&#xD;
&#xD;
          -  Less than 18 sessions in four month.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Cuvelier Antoine, Prof, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Muir Jean-François, Prof, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tardif Catherine, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Viacroze Catherine, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Debeaumont David, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patout Maxime, MD</last_name>
    <role>Study Chair</role>
    <affiliation>UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lamia Bouchra, Prof, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Quieffin Jean, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Prieur Guillaume, PT, MsC</last_name>
    <role>Study Chair</role>
    <affiliation>Service de pneumologie, Groupe Hospitalier du Havre, Fr</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Médrinal Clément, PT, MsC</last_name>
    <role>Study Chair</role>
    <affiliation>UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gravier Francis-Edouard, PT</last_name>
    <role>Study Chair</role>
    <affiliation>ADIR Association, Bois-Guillaume, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bonnevie Tristan, PT, MsC</last_name>
    <role>Study Chair</role>
    <affiliation>ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bonnevie</name>
      <address>
        <city>Bois-Guillaume</city>
        <zip>76230</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Médrinal</name>
      <address>
        <city>Le Havre</city>
        <zip>76600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT03244137
org study id: PR-COPD
nct id: NCT03244137
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic obstructive pulmonary disease is a leading cause of mortality worldwide.

      It is a systemic disease which includes pulmonary, cardiac, muscular, digestive and cognitive
      impairments.

      Pulmonary rehabilitation is a symptomatic treatment to reduce dyspnea and functional
      incapacity. However, it effects on cognitive dysfunction are not well known.

      The aim of this study is to assess the effects of a comprehensive pulmonary rehabilitation
      program on cognitive dysfunction in patients with severe to very severe chronic obstructive
      pulmonary disease using the Montreal Cognitive Assessment tool.
observational model: Cohort
time perspective: Prospective
measure: Baseline cognitive function
time frame: Cognitive function is assessed at the beginning of the rehabilitation program : day 0
description: Cognitive function is assessed with the Montreal Cognitive Assessement tool
measure: Cognitive function after pulmonary rehabilitation
time frame: Cognitive function is assessed at the end of the rehabilitation program : day 60
description: Cognitive function is assessed with the Montreal Cognitive Assessement tool
measure: Cognitive function : follow up
time frame: Cognitive function is assessed 3 month after rehabilitation : day 150
description: Cognitive function is assessed with the Montreal Cognitive Assessement tool
measure: Change in cognitive function from baseline to the end of pulmonary rehabilitation
time frame: Change in cognitive function from baseline to the end of pulmonary rehabilitation is assessed with end of pulmonary rehabilitation minus baseline values (day 60 - day 0)
description: Cognitive function is assessed with the Montreal Cognitive Assessement tool
measure: Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up
time frame: Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up is assessed with the 3 month of follow minus the end of pulmonary rehabilitation values (day 150 - day 60)
description: Cognitive function is assessed with the Montreal Cognitive Assessement tool
measure: Anxiety and depression : baseline
time frame: Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0
description: Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
measure: Anxiety and depression : end of pulmonary rehabilitation
time frame: Anxiety and depression are assessed at the end of the rehabilitation program : day 60
description: Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
measure: Anxiety and depression : follow up
time frame: Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150
description: Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
measure: Quality of life : baseline
time frame: Quality of life is assessed at the beginning of the rehabilitation program : day 0
description: Quality of life is assessed using the Saint Georges Respiratory Questionnaire
measure: Quality of life : end of pulmonary rehabilitation
time frame: Quality of life is assessed at the end of the rehabilitation program : day 60
description: Quality of life is assessed using the Saint Georges Respiratory Questionnaire
measure: Quality of life : follow-up
time frame: Quality of life is assessed 3 month after the end of the rehabilitation program : day 150
description: Quality of life is assessed using the Saint Georges Respiratory Questionnaire
measure: Functional capacity (six-minute stepper test) : baseline
time frame: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
description: Functional capacity is assessed with the six-minute stepper test
measure: Functional capacity (six-minute stepper test) : end of pulmonary rehabilitation
time frame: Functional capacity is assessed at the end of the rehabilitation program : day 60
description: Functional capacity is assessed with the six-minute stepper test
measure: Functional capacity (six-minute walk test) : baseline
time frame: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
description: Functional capacity is assessed with the six-minute walk test
measure: Adherence
time frame: Adherence is assessed at the end of the rehabilitation program : day 60
description: Adherence to the pulmonary rehabilitation program is assessed by the following equation : number of session performed divided by the number of scheduled sessions
measure: Relation between the cognitive function and the respiratory function (forced expiratory volume in 1 second)
time frame: The relation is assessed between baseline demographic data at day 0
description: Cognitive function is assessed with the Montreal Cognitive Assessement tool and respiratory function is assessed with spirometric evaluation
arm group label: Pulmonary rehabilitation
description: The whole population will benefit from a comprehensive pulmonary rehabilitation program, including aerobic training, superior and inferior limb strength training, self-management and add-on to pulmonary rehabilitation as needed (i.e : electrical muscle stimulation, inspiratory muscle training, non-invasive ventilation, high flow nasal canula).
intervention type: Other
intervention name: Pulmonary rehabilitation
description: See group description.
arm group label: Pulmonary rehabilitation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Cuvelier Antoine, Prof, PhD
role: Principal Investigator
affiliation: CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.
last name: Muir Jean-François, Prof, PhD
role: Study Chair
affiliation: CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France.
last name: Tardif Catherine, MD
role: Study Chair
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
last name: Viacroze Catherine, MD
role: Study Chair
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
last name: Debeaumont David, MD
role: Study Chair
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France.
last name: Patout Maxime, MD
role: Study Chair
affiliation: UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
last name: Lamia Bouchra, Prof, PhD
role: Study Chair
affiliation: UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France.
last name: Quieffin Jean, MD
role: Study Chair
affiliation: Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
last name: Prieur Guillaume, PT, MsC
role: Study Chair
affiliation: Service de pneumologie, Groupe Hospitalier du Havre, Fr
last name: Médrinal Clément, PT, MsC
role: Study Chair
affiliation: UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France
last name: Gravier Francis-Edouard, PT
role: Study Chair
affiliation: ADIR Association, Bois-Guillaume, France
last name: Bonnevie Tristan, PT, MsC
role: Study Chair
affiliation: ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive