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NCT Number: NCT06012006

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

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Key information

Conditions

COPD Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

constant work-rate cycling exercise test

Other

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 outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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)

    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.

  2. mMRC (Modified Medical Research Council) dyspnea score

    Time frame: 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.

  3. Dyspnoea 12

    Time frame: 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

  4. COPD Assessment Test (CAT) score

    Time frame: 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.

  5. Hospital Anxiety and Depression scale (HADS)

    Time frame: 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.

  6. Saint George Respiratory Questionnaire (SGRQ)

    Time frame: 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.

  7. VQ11

    Time frame: 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.

  8. lung function tests

    Time frame: 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)

  9. 6 minutes walk test

    Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

    Distance

  10. rise chair test (optional)

    Time frame: at inclusion and then, up to 6 weeks (at the end of pulmonary rehabilitation course)

    number of rise

Study contacts

Contact information is provided by the study sponsor or research team.

Capucine Morelot-Panzini, MD-PhD

CONTACT

[email protected]

0142167771 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: DYSCO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 25, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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