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

NCT02528487 | Suspended

• 1 other identifier: 2015-1132 (MP)
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary Rehabilitation; Chronic Obstructive Pulmonary Disease; Psychiatric Disorders

Outcome Measures

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).

  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

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

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• Mount Sinai Rehabilitation Hospital: collaborator
• Hopital Charles Lemoyne: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• Jewish Rehabilitation Hospital: collaborator

Study Sites (5)

Jewish Rehabilitation Hospital

Laval, Quebec, Canada

Location

Hopital Charles-Lemoyne

Longueuil, Quebec, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J1C5, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Location

Mount-Sinai Hospital

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Mental Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Grégory Moullec, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 19, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

CA (5)