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

Determination of the Minimal Clinically Significant Difference (MCID) of Multidimensional Dyspnea Profile (MDP) Scores in Chronic Obstructive Pulmonary Disease (COPD) Patients During Pulmonary Rehabilitation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD
• Intervention / Treatment: Other: constant work-rate cycling exercise test

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Capucine Morelot-Panzini, MD-PhD; Phone Number: +33 0142167771; Email: capucine.morelot@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pulmonary rehabilitation; COPD patients will be admitted for pulmonary rehabilitation, the duration and modalities of which vary from center to center.	Other: constant work-rate cycling exercise test; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
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.	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
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.	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
mMRC (Modified Medical Research Council) dyspnea score	This 5-level score assesses the intensity of dyspnea. The consideration period will be one week.	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
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	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
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.	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
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.	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
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.	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
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.	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
lung function tests	FEV1 measurement (before and after bronchodilation), FEV1/FVC measurement, inspiratory capacity (IC) measurement, RV measurement (optional)	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
6 minutes walk test	Distance	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
rise chair test (optional)	number of rise	at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Capucine Morelot-Panzini, MD, PhD, APHP

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: COPD; pulmonary rehabilitation; MDP; Breathlessness; MCID
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: APHP221339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No