Predictors of the Long-term Functional Benefits of a Pulm... | NCT02528487

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

NCT02528487

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Status

Suspended

Last Update Posted

Mar 15, 2019Actual

Enrollment

360Estimated

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Pending financial support

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Mar 2023Estimated

Completion Date

Mar 2023Estimated

First Submitted Date

Aug 17, 2015

First Submission Date that Met QC Criteria

Aug 18, 2015

First Posted Date

Aug 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2019

Last Update Posted Date

Mar 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Grégory Moullec, Researcher, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealPrincipal Investigator

Lead Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

360Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder 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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Grégory Moullec, Ph.D.	Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jewish Rehabilitation Hospital		Laval	Quebec		Canada
Hopital Charles-Lemoyne

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D001523	Mental Disorders

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided