Community-Based Maintenance Exercise Program for COPD

NCT ID: NCT01942499

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2018-07-31

Brief Summary

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It is well established that individuals living with chronic obstructive pulmonary disease (COPD) demonstrate significant improvements following a formal rehabilitation program. The problem lies in the fact that these functional improvements diminish over a 12 month period. This decline in function is associated with decreased participation, a decline in health status, and an increased need to access the healthcare system. The objective of this project is to evaluate the effectiveness of a post-rehabilitation community-based exercise program for individuals with COPD and compare the outcomes with those achieved through standard care.

Individuals with COPD who have completed a previous rehabilitation program will be enrolled in the study. Study participants will be assigned randomly to either a year-long community exercise program or usual care. Those assigned to the community program will exercise twice weekly at a local community centre supervised by trained fitness instructors. A case manager will facilitate the transition from the hospital rehabilitation program to the community centre. The case manager will also be available to participants and instructors for consult as needed. Continuing to build on an established partnership with the City of Toronto, the case manager will ensure fitness instructors receive specialized training in order to properly supervise and support the individuals with COPD. Participants assigned to usual care group will receive standard care by their family physician and respiratory specialist. Functional status will be evaluated before the program begins and again at 6-months and 1-year. The outcome of each group will be compared to determine the effectiveness of the community exercise program. It is hypothesized that individuals who participate in the community exercise program will have better function and quality of life versus those individuals who receive standard care.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Community Exercise Group

Community-based exercise program for one year

Group Type OTHER

Community-based exercise program

Intervention Type OTHER

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Community-based exercise program

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* individuals with moderate to severe COPD based on international (GOLD) criteria
* clinically stable
* able to provide their own informed consent
* able to secure independent transportation to the community site

Exclusion Criteria

* individuals with associated medical conditions that limit their exercise tolerance (cardiovascular, musculo-skeletal, recent surgery, etc.)
* individuals who report a history of significant cardiovascular disease (i.e. congestive cardiac failure, history of cardiac arrest, acute myocardial infarction within the preceding three months, symptomatic ischaemic cardiac disease, uncontrolled systemic hypertension) or report severe non-respiratory symptoms during exercise
* individuals receiving mechanical ventilation
* individuals who are unable to attend the community-based exercise program or follow-up assessment sessions
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Lung Association

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

West Park Healthcare Centre

OTHER

Sponsor Role lead

Responsible Party

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Roger Goldstein

Respirologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roger Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

West Park Healthcare Centre

Locations

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Trillium Health Partners- Credit Valley Hospital

Mississauga, Ontario, Canada

Site Status

St. Joseph's Care Group

Thunder Bay, Ontario, Canada

Site Status

West Park Healthcare Centre

Toronto, Ontario, Canada

Site Status

Lakeridge Health

Whitby, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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12-006-WP

Identifier Type: -

Identifier Source: org_study_id

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