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SuspendedNCT02528487Updated Mar 15, 2019

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

An observational study in Chronic Obstructive Pulmonary Disease, sponsored by Hopital du Sacre-Coeur de Montreal. Suspended at 5 sites in Canada. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-03-15.

Sponsored by Hopital du Sacre-Coeur de Montreal · Observational

Why this study was suspended
Pending financial support
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
360
Ages
40 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Pulmonary Rehabilitation
  • Chronic Obstructive Pulmonary Disease
  • Psychiatric Disorders
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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 360 is above the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Hopital du Sacre-Coeur de Montreal is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
360 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. The change in exercise tolerance at 1-year post-PR

    Exercise tolerance will be measured with the 6-minute walking test (6MWT).

    Time frame: Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.

Secondary outcomes

  1. 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

    Time frame: Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.

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Study locations

5 sites
  • Jewish Rehabilitation Hospital
    Laval, Quebec, Canada
  • Hopital Charles-Lemoyne
    Longueuil, Quebec, Canada
  • Hopital du Sacre-Coeur de Montreal
    Montreal, Quebec H4J1C5, Canada
  • Centre hospitalier de l'Université de Montréal (CHUM)
    Montreal, Quebec, Canada
  • Mount-Sinai Hospital
    Montreal, Quebec, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02528487
Lead sponsor
Hopital du Sacre-Coeur de Montreal
Collaborators
Mount Sinai Rehabilitation Hospital, Hopital Charles Lemoyne, Centre hospitalier de l'Université de Montréal (CHUM), Jewish Rehabilitation Hospital
Responsible party
Grégory Moullec (Researcher, Hopital du Sacre-Coeur de Montreal) — Principal investigator
First posted
Aug 19, 2015
Start date
May 2015
Primary completion
Mar 2023 (estimated)
Completion
Mar 2023 (estimated)
Last update
Mar 15, 2019

Study contacts

Grégory Moullec, Ph.D.
principal investigator · Hopital du Sacre-Coeur de Montreal

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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