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

NCT ID: NCT06012006

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-11-30

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.

Conditions

COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

pulmonary rehabilitation

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

Group Type: EXPERIMENTAL

constant work-rate cycling exercise test

Intervention Type: 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

Interventions

constant 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Capucine Morelot-Panzini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Central Contacts

Capucine Morelot-Panzini, MD-PhD

Role: CONTACT

capucine.morelot@aphp.fr

0142167771 ext. +33

Other Identifiers

APHP221339

Identifier Type: -

Identifier Source: org_study_id