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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02528487
• Other study ID #: 2015-1132 (MP)
• Status: Suspended
• Start date: May 2015
• Est. completion date: March 2023

Study information

• Verified date: March 2019
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 360
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Canada	Jewish Rehabilitation Hospital	Laval	Quebec
Canada	Hopital Charles-Lemoyne	Longueuil	Quebec
Canada	Centre hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec
Canada	Hopital du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Mount-Sinai Hospital	Montreal	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal	Centre hospitalier de l'Université de Montréal (CHUM), Hopital Charles Lemoyne, Jewish Rehabilitation Hospital, Mount Sinai Rehabilitation Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in exercise tolerance at 1-year post-PR	Exercise tolerance will be measured with the 6-minute walking test (6MWT).	Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.
Secondary	The change in health-related quality of life (HRQoL) at 1-year post-PR	HRQoL will be measured with the 12-Item Short Form Survey and the COPD Assessment Test	Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.