Pulmonary Rehabilitation for COPD Patients: Can Performance Predict Exacerbation?

COPD Clinical Trial

— PREDICT  

Official title:

Pulmonary Rehabilitation for COPD Patients: Can Performance Predict Exacerbation?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492149
• Other study ID #: 2022-A00210-43
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2022
• Source: Groupe Hospitalier du Havre
• Contact: Clement Medrinal
• Phone: +33630039745
• Email: medrinal.clement.mk[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of pulmonary rehabilitation is to improve exercise capacity and reduce dyspnoea. As well as improving the patient's overall condition, pulmonary rehabilitation provides a means to monitor the patient regularly. During physical exercise, the increased activity of the muscle system increases cardiac and respiratory output. If the patient's respiratory status deteriorates, as occurs, for example, before the onset of an exacerbation, exercise capacity could be reasonably expected to reduce. The investigators hypothesised, therefore, that changes in the physical capacity of patients with COPD during a rehabilitation session could provide a predictive indication regarding the risk of occurrence of exacerbation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients

• COPD patients

Exclusion Criteria:

• Patients who not performed not at least 5 sessions of the pulmonary rehabilitation program

• Occurence of an adverse event that prevents further rehabilitation

• Exacerbation in the previous month

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Rehabilitation

Intervention

Other:
• Performance follow-up
Diary performance during rehabilitation will be collected and a CAT questionnaire will be completed by the patient.

Locations

Country	Name	City	State
France	Groupe Hospitalier du Havre	Montivilliers	Groupe Hospitalier Du Havre

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the decrease of performance during pulmonary rehabilitation session and the occurrence of pulmonary exacerbation.	The change in performance rehabilitation of patients between the last session will be screen when a patients will be admitted to hospital for a COPD exacerbation.	From admission to the program or first documented session ; to completion of the pulmonary rehabilitation program or occurrence of an exacerbation, up to 104 weeks.
Secondary	Correlation between the decrease of performance during pulmonary rehabilitation session and the COPD Assessment Test (CAT) questionnaire score.	The change in performance rehabilitation of patients between the last session will be screen and compared to a COPD Assessment Test (CAT) questionnaire score.	Through study completion, at every pulmonary rehabilitation session ; to completion of the pulmonary rehabilitation program or occurrence of an exacerbation, up to 104 weeks.