Chronic Obstructive Pulmonary DiseaseNCT02528487
Predictors of the Long-term Functional Benefits of a Pulmonary Rehabilitation Program?
An observational study of Chronic Obstructive Pulmonary Disease, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 5 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 360 participants
- Where
- 5 sitesCanada
- Study dates
- May 2015to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Patients over the age of 40 will be eligible if
- they are diagnosed with moderate-severe COPD,
- currently participate to a PR program, and
- agree to participate.
Who cannot join
- They will be excluded if:
- they have any comorbidity that is more important (i.e., more likely to cause morbidity or mortality) than COPD (e.g., active cancer),
- they have contraindications to exercise (though they will not likely be referred to PR),
- they have participated in a PR program in the past year,
- and if they are unable to provide informed consent due to language difficulties or cognitive impairment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Jewish Rehabilitation Hospital
Laval, Quebec
Hopital Charles-Lemoyne
Longueuil, Quebec
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J1C5
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
Mount-Sinai Hospital
Montreal, Quebec
About this study
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary Rehabilitation, Chronic Obstructive Pulmonary Disease, Psychiatric Disorders
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in exercise tolerance at 1-year post-PR
Exercise tolerance will be measured with the 6-minute walking test (6MWT).
Measured: 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
Measured: Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: Pending financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Rehabilitation Hospital, Hopital Charles Lemoyne, Centre hospitalier de l'Université de Montréal (CHUM), Jewish Rehabilitation Hospital
- Responsible party
- Principal investigator, Grégory Moullec, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Grégory Moullec, Ph.D., Principal investigator, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528487
- Sponsor's protocol ID
- 2015-1132 (MP)
- Status last verified
- Mar 2019
- First submitted
- 17 Aug 2015
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of the Long-term Functional Benefits of a Pulmonary Rehabilitation Program?
- ClinicalTrials.gov ID
- NCT02528487
- Acronym / sponsor ID
- 2015-1132 (MP)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary Rehabilitation, Chronic Obstructive Pulmonary Disease, Psychiatric Disorders
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Pending financial support
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Collaborators
- Mount Sinai Rehabilitation Hospital, Hopital Charles Lemoyne, Centre hospitalier de l'Université de Montréal (CHUM), Jewish Rehabilitation Hospital
- Study start
- May 2015 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- Patients over the age of 40 will be eligible if
- they are diagnosed with moderate-severe COPD,
- currently participate to a PR program, and
- agree to participate.
Key exclusion criteria (5 listed)
- they have any comorbidity that is more important (i.e., more likely to cause morbidity or mortality) than COPD (e.g., active cancer),
- they have contraindications to exercise (though they will not likely be referred to PR),
- they have participated in a PR program in the past year,
- and if they are unable to provide informed consent due to language difficulties or cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grégory Moullec, Ph.D. principal investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.