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

March 13, 2019 updated by: Grégory Moullec, Hopital du Sacre-Coeur de Montreal
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.

Study Overview

Status

Suspended

Conditions

Study Type

Observational

Enrollment (Anticipated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Laval, Quebec, Canada
        • Jewish Rehabilitation Hospital
      • Longueuil, Quebec, Canada
        • Hôpital Charles-LeMoyne
      • Montreal, Quebec, Canada
        • Centre Hospitalier de l'Université de Montréal (CHUM)
      • Montreal, Quebec, Canada, H4J1C5
        • Hôpital du Sacré-Coeur de Montréal
      • Montreal, Quebec, Canada
        • Mount-Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in exercise tolerance at 1-year post-PR
Time Frame: 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).
Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in health-related quality of life (HRQoL) at 1-year post-PR
Time Frame: 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
Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital du Sacre-Coeur de Montreal

Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)
Jewish Rehabilitation Hospital
Mount Sinai Rehabilitation Hospital
Hopital Charles Lemoyne

Investigators

  • Principal Investigator: Grégory Moullec, Ph.D., Hôpital du Sacré-Coeur de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

August 17, 2015

First Submitted That Met QC Criteria

August 18, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-1132 (MP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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