COPD
Conditions
Keywords
Breathlessness, MCID, COPD, MDP, pulmonary rehabilitation
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.
Interventions
OTHERconstant 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
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| multidimensional (MDP) questionnaire | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | 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 | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | 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 | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | 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
| Measure | Time frame | Description |
|---|---|---|
| COPD Assessment Test (CAT) score | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | 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) | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | 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) | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | 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. |
| Affective and Sensory dyspnea visual analog scale (VAS) | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | 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. |
| lung function tests | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | FEV1 measurement (before and after bronchodilation), FEV1/FVC measurement, inspiratory capacity (IC) measurement, RV measurement (optional) |
| 6 minutes walk test | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | Distance |
| rise chair test (optional) | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | number of rise |
| VQ11 | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | 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. |
| mMRC (Modified Medical Research Council) dyspnea score | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | This 5-level score assesses the intensity of dyspnea. The consideration period will be one week. |
| Dyspnoea 12 | at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course) | 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 |
Contacts
Primary ContactCapucine Morelot-Panzini, MD-PhD
Outcome results
None listed