xml: <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/NCT06012006</url>
    </required_header>
    <id_info>
      <org_study_id>APHP221339</org_study_id>
      <nct_id>NCT06012006</nct_id>
    </id_info>
    <brief_title>Minimal Clinically Significant Difference (MCID) of Multidimensional Dyspnea Profile (MDP) in COPD Patients Undergoing Respiratory Rehabilitation</brief_title>
    <acronym>DYSCO</acronym>
    <official_title>Determination of the Minimal Clinically Significant Difference (MCID) of Multidimensional Dyspnea Profile (MDP) Scores in Chronic Obstructive Pulmonary Disease (COPD) Patients During Pulmonary Rehabilitation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</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 study is designed to determine the individual threshold of minimal clinical change&#xD;
        (MCID) for each component of the Multidimensional Dyspnea Profile (MDP) questionnaire in COPD&#xD;
        patients undergoing pulmonary rehabilitation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of the research is to determine the minimal clinically significant difference (MCID)&#xD;
        in MDP scores in COPD patients after a respiratory rehabilitation course using the anchoring&#xD;
        method :&#xD;
  &#xD;
          -  The A1 score will be compared with the Borg Affective Dyspnea (BorgA) scale.&#xD;
  &#xD;
          -  The sensory score will be compared with the Borg Sensory Dyspnea Scale (BorgS).&#xD;
  &#xD;
          -  The 5 sensory items will be compared with the Borg Sensory Dyspnea scale.&#xD;
  &#xD;
          -  The emotional score will be compared with the Borg Emotional Dyspnea Scale.&#xD;
  &#xD;
          -  The 5 emotional items will be compared with the Borg affective dyspnea scale. The&#xD;
             various questionnaires will be administered to patients at inclusion, after a constant&#xD;
             work-rate cycling exercise test, and at isotime during the same cycling exercise test at&#xD;
             the end of the pulmonary rehabilitation course.&#xD;
  &#xD;
        The sensitivity study will be conducted using the visual analog dyspnea scale instead of the&#xD;
        Borg score. Finally, we will also determine the MCID using the distribution method. The MCID&#xD;
        score will be correlated with various quality of life and physical performance scores.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <phase>N/A</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>multidimensional (MDP) questionnaire</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>The multidimensional questionnaire measuring the sensory component of dyspnea (intensity of the 5 respiratory descriptors) and the affective component of dyspnea (immediate discomfort and intensity of emotional responses). The MDP will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>sensory Borg scale</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>The two Borg scales will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>affective Borg scale</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>The two Borg scales will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Affective and Sensory dyspnea visual analog scale (VAS)</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>Affective and sensory dyspnea VAS will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mMRC (Modified Medical Research Council) dyspnea score</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>This 5-level score assesses the intensity of dyspnea. The consideration period will be one week.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dyspnoea 12</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>Multidimensional dyspnea questionnaire comprising 12 items (7 sensory and 5 affective) that can be rated from 0 (absent) to 3 (severe), i.e. a score from 0 to 36. This questionnaire measures dyspnoea over the period &quot;these days&quot;. The consideration period will be one week</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>COPD Assessment Test (CAT) score</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>This questionnaire comprises 8 questions on a scale from 0 (best condition) to 5 (worst condition). The total score corresponds to the sum of the scores for each question: it ranges from 0 to 40.The consideration period will be one week.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Anxiety and Depression scale (HADS)</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>Anxiety and depression, measured by the two subscore of the HADS scale. Each subscore comprises 7 items rated from 0 (no symptoms) to 3. Seven questions relate to anxiety (total A) and seven questions relate to depression enabling us to obtain the score (maximum score = 42)The consideration period will be one week.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Saint George Respiratory Questionnaire (SGRQ)</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>evaluated by a total score and three sub-scores (symptoms, activity and impact). The total score and each sub-score are scaled from 0 to 100. The higher the score, the poorer the quality of life.The consideration period will be one week.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VQ11</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>questionnaire consisting of 11 questions evaluated by a total score and 3 sub-scores (functional - 3 items, psychological: 4 items; relational - 4 items). Each question has 5 possible response levels, with ratings on a Likert scale ranging from 1 (not at all) to 5 (extremely). The functional, psychological and relational scores are respectively rated out of 15 for the first and 20 for the last two. The total score ranges from 11 to 55. A VQ11 total score greater than or equal to 22 reflects a patient's poor health-related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lung function tests</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>FEV1 measurement (before and after bronchodilation), FEV1/FVC measurement, inspiratory capacity (IC) measurement, RV measurement (optional)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6 minutes walk test</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>Distance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>rise chair test (optional)</measure>
      <time_frame>at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)</time_frame>
      <description>number of rise</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>COPD</condition>
    <arm_group>
      <arm_group_label>pulmonary rehabilitation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>COPD patients will be admitted for pulmonary rehabilitation, the duration and modalities of which vary from center to center.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>constant work-rate cycling exercise test</intervention_name>
      <description>Description: at the end of pulmonary rehabilitation, a constant work-rate second cycling exercise test will be performed with the same duration as the cycling exercise test at inclusion</description>
      <arm_group_label>pulmonary rehabilitation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Gold B or D COPD patient&#xD;
  &#xD;
            -  Moderate to severe obstructive ventilatory disorder (FEV1&lt;80%)&#xD;
  &#xD;
            -  Admitted for a pulmonary rehabilitation&#xD;
  &#xD;
            -  Having given free, informed and written consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lack of French language skills, preventing completion of questionnaires&#xD;
  &#xD;
            -  Cognitive impairment preventing completion of questionnaires&#xD;
  &#xD;
            -  Patient under guardianship&#xD;
  &#xD;
            -  Patient not affiliated to the social security system&#xD;
  &#xD;
            -  Chronic ethylism&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Capucine Morelot-Panzini, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>APHP</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Capucine Morelot-Panzini, MD-PhD</last_name>
      <phone>0142167771</phone>
      <phone_ext>+33</phone_ext>
      <email>capucine.morelot@aphp.fr</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Breathlessness</keyword>
    <keyword>MCID</keyword>
    <keyword>COPD</keyword>
    <keyword>MDP</keyword>
    <keyword>pulmonary rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyspnea</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012006
  org study id: APHP221339
  nct id: NCT06012006
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is designed to determine the individual threshold of minimal clinical change
        (MCID) for each component of the Multidimensional Dyspnea Profile (MDP) questionnaire in COPD
        patients undergoing pulmonary rehabilitation.
  The aim of the research is to determine the minimal clinically significant difference (MCID)
        in MDP scores in COPD patients after a respiratory rehabilitation course using the anchoring
        method :
  
          -  The A1 score will be compared with the Borg Affective Dyspnea (BorgA) scale.
  
          -  The sensory score will be compared with the Borg Sensory Dyspnea Scale (BorgS).
  
          -  The 5 sensory items will be compared with the Borg Sensory Dyspnea scale.
  
          -  The emotional score will be compared with the Borg Emotional Dyspnea Scale.
  
          -  The 5 emotional items will be compared with the Borg affective dyspnea scale. The
             various questionnaires will be administered to patients at inclusion, after a constant
             work-rate cycling exercise test, and at isotime during the same cycling exercise test at
             the end of the pulmonary rehabilitation course.
  
        The sensitivity study will be conducted using the visual analog dyspnea scale instead of the
        Borg score. Finally, we will also determine the MCID using the distribution method. The MCID
        score will be correlated with various quality of life and physical performance scores.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: multidimensional (MDP) questionnaire
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: The multidimensional questionnaire measuring the sensory component of dyspnea (intensity of the 5 respiratory descriptors) and the affective component of dyspnea (immediate discomfort and intensity of emotional responses). The MDP will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.
  measure: sensory Borg scale
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: The two Borg scales will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.
  measure: affective Borg scale
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: The two Borg scales will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.
  measure: Affective and Sensory dyspnea visual analog scale (VAS)
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: Affective and sensory dyspnea VAS will be carried out at the end of the constant work-rate cycling exercise test, taking into account the last 30 seconds.
  measure: mMRC (Modified Medical Research Council) dyspnea score
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: This 5-level score assesses the intensity of dyspnea. The consideration period will be one week.
  measure: Dyspnoea 12
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: Multidimensional dyspnea questionnaire comprising 12 items (7 sensory and 5 affective) that can be rated from 0 (absent) to 3 (severe), i.e. a score from 0 to 36. This questionnaire measures dyspnoea over the period "these days". The consideration period will be one week
  measure: COPD Assessment Test (CAT) score
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: This questionnaire comprises 8 questions on a scale from 0 (best condition) to 5 (worst condition). The total score corresponds to the sum of the scores for each question: it ranges from 0 to 40.The consideration period will be one week.
  measure: Hospital Anxiety and Depression scale (HADS)
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: Anxiety and depression, measured by the two subscore of the HADS scale. Each subscore comprises 7 items rated from 0 (no symptoms) to 3. Seven questions relate to anxiety (total A) and seven questions relate to depression enabling us to obtain the score (maximum score = 42)The consideration period will be one week.
  measure: Saint George Respiratory Questionnaire (SGRQ)
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: evaluated by a total score and three sub-scores (symptoms, activity and impact). The total score and each sub-score are scaled from 0 to 100. The higher the score, the poorer the quality of life.The consideration period will be one week.
  measure: VQ11
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: questionnaire consisting of 11 questions evaluated by a total score and 3 sub-scores (functional - 3 items, psychological: 4 items; relational - 4 items). Each question has 5 possible response levels, with ratings on a Likert scale ranging from 1 (not at all) to 5 (extremely). The functional, psychological and relational scores are respectively rated out of 15 for the first and 20 for the last two. The total score ranges from 11 to 55. A VQ11 total score greater than or equal to 22 reflects a patient's poor health-related quality of life.
  measure: lung function tests
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: FEV1 measurement (before and after bronchodilation), FEV1/FVC measurement, inspiratory capacity (IC) measurement, RV measurement (optional)
  measure: 6 minutes walk test
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: Distance
  measure: rise chair test (optional)
  time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
  description: number of rise
  arm group label: pulmonary rehabilitation
  arm group type: Experimental
  description: COPD patients will be admitted for pulmonary rehabilitation, the duration and modalities of which vary from center to center.
  intervention type: Other
  intervention name: constant work-rate cycling exercise test
  description: Description: at the end of pulmonary rehabilitation, a constant work-rate second cycling exercise test will be performed with the same duration as the cycling exercise test at inclusion
  arm group label: pulmonary rehabilitation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Capucine Morelot-Panzini, MD, PhD
  role: Principal Investigator
  affiliation: APHP
  last name: Capucine Morelot-Panzini, MD-PhD
  phone: 0142167771
  phone ext: +33
  email: capucine.morelot@aphp.fr
  responsible party type: Sponsor
  mesh term: Dyspnea
  sharing ipd: No