Predictors of the Long-term Functional Benefits of a Pulmonary Rehabilitation Program?

Suspended

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT02528487
• Lead Sponsor: Hopital du Sacre-Coeur de Montreal

Brief Summary

The present study aims to assess the prevalence and impact of comorbid psychiatric disorders among patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation (PR), in order to determine the effects of psychiatric comorbidity on exercise tolerance and physical activity post-PR and HRQoL, as well as to determine the processes by which these psychiatric disorders may impact on these patient behaviours.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-15
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Patients over the age of 40 will be eligible if
2. they are diagnosed with moderate-severe COPD,
3. currently participate to a PR program, and
4. agree to participate.

Exclusion Criteria

They will be excluded if:

1. they have any comorbidity that is more important (i.e., more likely to cause morbidity or mortality) than COPD (e.g., active cancer),
2. they have contraindications to exercise (though they will not likely be referred to PR),
3. they have participated in a PR program in the past year,
4. and if they are unable to provide informed consent due to language difficulties or cognitive impairment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in exercise tolerance at 1-year post-PR	Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.	Exercise tolerance will be measured with the 6-minute walking test (6MWT).

Secondary Outcome Measures

Name	Time	Method
The change in health-related quality of life (HRQoL) at 1-year post-PR	Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.	HRQoL will be measured with the 12-Item Short Form Survey and the COPD Assessment Test

Trial Locations

Locations (5)

Hopital du Sacre-Coeur de Montreal; 🇨🇦 Montreal, Quebec, Canada

Jewish Rehabilitation Hospital; 🇨🇦 Laval, Quebec, Canada

Mount-Sinai Hospital; 🇨🇦 Montreal, Quebec, Canada

Centre hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada

Hopital Charles-Lemoyne; 🇨🇦 Longueuil, Quebec, Canada