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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: COPD

Treatments: Other: constant work-rate cycling exercise test

Study type: Interventional

Funder types: Other

Identifiers

NCT06012006

APHP221339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

pulmonary rehabilitation

Experimental group

Description:

COPD patients will be admitted for pulmonary rehabilitation, the duration and modalities of which vary from center to center.

Treatment:

Other: constant work-rate cycling exercise test