Clinical trial NCT06012006: Minimal Clinically Significant Difference (MCID) of Multidimensional Dyspnea Profile (MDP) in COPD Patients Undergoing Respiratory Rehabilitation
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD
Keywords: Breathlessness
MCID
COPD
MDP
pulmonary rehabilitation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: multidimensional (MDP) questionnaire
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
measure: sensory Borg scale
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
measure: affective Borg scale
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
Secondary outcomes:
measure: Affective and Sensory dyspnea visual analog scale (VAS)
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
measure: mMRC (Modified Medical Research Council) dyspnea score
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
measure: Dyspnoea 12
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
measure: COPD Assessment Test (CAT) score
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
measure: Hospital Anxiety and Depression scale (HADS)
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
measure: Saint George Respiratory Questionnaire (SGRQ)
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
measure: VQ11
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
measure: lung function tests
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
measure: 6 minutes walk test
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
measure: rise chair test (optional)
timeFrame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
Other outcomes:
Locations:
Study officials:
affiliation: APHP
name: Capucine Morelot-Panzini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: