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
About this trial
This is an interventional basic science trial for COPD focused on measuring Breathlessness, MCID, COPD, MDP, pulmonary rehabilitation
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
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
NCT ID
NCT06012006
First Posted
July 24, 2023
Last Updated
August 21, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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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