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Minimal Clinically Significant Difference (MCID) of Multidimensional Dyspnea Profile (MDP) in COPD Patients Undergoing Respiratory Rehabilitation (DYSCO)

Primary Purpose

COPD

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
constant work-rate cycling exercise test
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COPD focused on measuring Breathlessness, MCID, COPD, MDP, pulmonary rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Gold B or D COPD patient Moderate to severe obstructive ventilatory disorder (FEV1<80%) Admitted for a pulmonary rehabilitation Having given free, informed and written consent Exclusion Criteria: Lack of French language skills, preventing completion of questionnaires Cognitive impairment preventing completion of questionnaires Patient under guardianship Patient not affiliated to the social security system Chronic ethylism

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    pulmonary rehabilitation

    Arm Description

    COPD patients will be admitted for pulmonary rehabilitation, the duration and modalities of which vary from center to center.

    Outcomes

    Primary Outcome Measures

    multidimensional (MDP) questionnaire
    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.
    sensory Borg scale
    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.
    affective Borg scale
    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.

    Secondary Outcome Measures

    Affective and Sensory dyspnea visual analog scale (VAS)
    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.
    mMRC (Modified Medical Research Council) dyspnea score
    This 5-level score assesses the intensity of dyspnea. The consideration period will be one week.
    Dyspnoea 12
    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
    COPD Assessment Test (CAT) score
    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.
    Hospital Anxiety and Depression scale (HADS)
    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.
    Saint George Respiratory Questionnaire (SGRQ)
    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.
    VQ11
    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.
    lung function tests
    FEV1 measurement (before and after bronchodilation), FEV1/FVC measurement, inspiratory capacity (IC) measurement, RV measurement (optional)
    6 minutes walk test
    Distance
    rise chair test (optional)
    number of rise

    Full Information

    First Posted
    July 24, 2023
    Last Updated
    August 21, 2023
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06012006
    Brief Title
    Minimal Clinically Significant Difference (MCID) of Multidimensional Dyspnea Profile (MDP) in COPD Patients Undergoing Respiratory Rehabilitation
    Acronym
    DYSCO
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COPD
    Keywords
    Breathlessness, MCID, COPD, MDP, pulmonary rehabilitation

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pulmonary rehabilitation
    Arm Type
    Experimental
    Arm 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(s)
    constant work-rate cycling exercise test
    Intervention 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
    Primary Outcome Measure Information:
    Title
    multidimensional (MDP) questionnaire
    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.
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Title
    sensory Borg scale
    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.
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Title
    affective Borg scale
    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.
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Secondary Outcome Measure Information:
    Title
    Affective and Sensory dyspnea visual analog scale (VAS)
    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.
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Title
    mMRC (Modified Medical Research Council) dyspnea score
    Description
    This 5-level score assesses the intensity of dyspnea. The consideration period will be one week.
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Title
    Dyspnoea 12
    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
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Title
    COPD Assessment Test (CAT) score
    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.
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Title
    Hospital Anxiety and Depression scale (HADS)
    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.
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Title
    Saint George Respiratory Questionnaire (SGRQ)
    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.
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Title
    VQ11
    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.
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Title
    lung function tests
    Description
    FEV1 measurement (before and after bronchodilation), FEV1/FVC measurement, inspiratory capacity (IC) measurement, RV measurement (optional)
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Title
    6 minutes walk test
    Description
    Distance
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
    Title
    rise chair test (optional)
    Description
    number of rise
    Time Frame
    at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Gold B or D COPD patient Moderate to severe obstructive ventilatory disorder (FEV1<80%) Admitted for a pulmonary rehabilitation Having given free, informed and written consent Exclusion Criteria: Lack of French language skills, preventing completion of questionnaires Cognitive impairment preventing completion of questionnaires Patient under guardianship Patient not affiliated to the social security system Chronic ethylism
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Capucine Morelot-Panzini, MD-PhD
    Phone
    0142167771
    Ext
    +33
    Email
    capucine.morelot@aphp.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Capucine Morelot-Panzini, MD, PhD
    Organizational Affiliation
    APHP
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Minimal Clinically Significant Difference (MCID) of Multidimensional Dyspnea Profile (MDP) in COPD Patients Undergoing Respiratory Rehabilitation

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