COPDDYSCONCT06012006
Minimal Clinically Significant Difference (MCID) of Multidimensional Dyspnea Profile (MDP) in COPD Patients Undergoing Respiratory Rehabilitation
A study testing constant work-rate cycling exercise test in people with COPD, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- constant work-rate cycling exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- COPD
- Being tested
- constant work-rate cycling exercise test
- Keywords
- Breathlessness, MCID, COPD, MDP, pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
constant work-rate cycling exercise testOther
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
| Study group | Role | What they receive |
|---|---|---|
| pulmonary rehabilitation | Experimental | COPD patients will be admitted for pulmonary rehabilitation, the duration and modalities of which vary from center to center. Receives: Other: constant work-rate cycling exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
6 minutes walk test
Distance
Measured: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
rise chair test (optional)
number of rise
Measured: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study startSep 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Capucine Morelot-Panzini, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012006
- Sponsor's protocol ID
- APHP221339
- Acronym
- DYSCO
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06012006
- Acronym / sponsor ID
- DYSCO / APHP221339
- Conditions
- COPD
- Keywords
- Breathlessness, MCID, COPD, MDP, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary rehabilitation | Experimental | Other: constant work-rate cycling exercise testCOPD patients will be admitted for pulmonary rehabilitation, the duration and modalities of which vary from center to center. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| constant work-rate cycling exercise testDescription: 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 | Other | pulmonary rehabilitation |
Primary outcome
multidimensional (MDP) questionnaire
Time frame: 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
Time frame: 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
Time frame: 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.
10 secondary outcomes
Affective and Sensory dyspnea visual analog scale (VAS)
Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
mMRC (Modified Medical Research Council) dyspnea score
Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
Dyspnoea 12
Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
COPD Assessment Test (CAT) score
Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
Hospital Anxiety and Depression scale (HADS)
Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
Saint George Respiratory Questionnaire (SGRQ)
Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
VQ11
Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
lung function tests
Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
6 minutes walk test
Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
rise chair test (optional)
Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Capucine Morelot-Panzini, MD, PhD principal investigator
APHP
Questions about this trial
What is this clinical trial studying?
A study testing constant work-rate cycling exercise test in people with COPD, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Capucine Morelot-Panzini, MD-PhD (0142167771 ext. +33, capucine.morelot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
multidimensional (MDP) questionnaire (time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.