Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomized Controlled Trial of a Post-rehabilitation Community-based Exercise Program for Individuals With COPD
NCT number | NCT01942499 |
Other study ID # | 12-006-WP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2012 |
Est. completion date | July 2018 |
Verified date | July 2018 |
Source | West Park Healthcare Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | July 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Trillium Health Partners- Credit Valley Hospital | Mississauga | Ontario |
Canada | St. Joseph's Care Group | Thunder Bay | Ontario |
Canada | West Park Healthcare Centre | Toronto | Ontario |
Canada | Lakeridge Health | Whitby | Ontario |
Lead Sponsor | Collaborator |
---|---|
West Park Healthcare Centre | Canadian Institutes of Health Research (CIHR), Ontario Lung Association |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Six Minute Walk Test at 6 months | Baseline and 6 months | ||
Primary | Change from baseline in Six Minute Walk Test at 12 months | Baseline and 12 months | ||
Secondary | Change from baseline in Chronic Respiratory Disease Questionnaire at 6 months | Baseline and 6 months | ||
Secondary | Change from baseline in Repeated Chair Stand at 6 months | Baseline and 6 months | ||
Secondary | Change from baseline in Duke Activity Status Index at 6 months | Baseline and 6 months | ||
Secondary | Change from baseline in Health Utilities Index at 6 months | Baseline and 6 months | ||
Secondary | Change in baseline in COPD Self-Efficacy Scale at 6 months | Baseline and 6 months | ||
Secondary | Change from baseline in Chronic Respiratory Disease Questionnaire at 12 months | Baseline and 12 months | ||
Secondary | Change from baseline in Duke Activity Status Index at 12 months | Baseline and 12 months | ||
Secondary | Change from baseline in Health Utilities Index at 12 months | Baseline and 12 months | ||
Secondary | Change from baseline in Repeated Chair Stand at 12 months | Baseline and 12 months | ||
Secondary | Change in baseline in COPD Self-Efficacy Scale at 12 months | Baseline and 12 months |
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