Clinical trial NCT02528487: Predictors of the Long-term Functional Benefits of a Pulmonary Rehabilitation Program?
Official title: Predictors of the Long-term Functional Benefits of a Pulmonary Rehabilitation Program?
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary Rehabilitation
Chronic Obstructive Pulmonary Disease
Psychiatric Disorders
Lead sponsor: Hopital du Sacre-Coeur de Montreal
Sponsor class: OTHER
Collaborators: name: Mount Sinai Rehabilitation Hospital
name: Hopital Charles Lemoyne
name: Centre hospitalier de l'Université de Montréal (CHUM)
name: Jewish Rehabilitation Hospital
First posted: 2015-08-19
Enrollment: 360
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients will be consecutively recruited at entry in one of six PR programs in the Montreal area: Hôpital du Sacré-Coeur de Montréal (HSCM), Mount Sinai Hospital, Hôtel-Dieu de Montréal (CHUM), and Hôpital Charles-LeMoyne, Jewish Rehabilitation Hospital of Laval, McGill University Health Centre (MUHC).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change in exercise tolerance at 1-year post-PR
timeFrame: Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.
Secondary outcomes:
measure: The change in health-related quality of life (HRQoL) at 1-year post-PR
timeFrame: Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Jewish Rehabilitation Hospital
state: Quebec
city: Longueuil
country: Canada
facility: Hopital Charles-Lemoyne
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: Mount-Sinai Hospital
state: Quebec
Study officials:
affiliation: Hopital du Sacre-Coeur de Montreal
name: Grégory Moullec, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: