Community-Based Maintenance Exercise Program for COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Randomized Controlled Trial of a Post-rehabilitation Community-based Exercise Program for Individuals With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942499
• Other study ID #: 12-006-WP
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: West Park Healthcare Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Community-based exercise program

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
West Park Healthcare Centre	Canadian Institutes of Health Research (CIHR), Ontario Lung Association

Country where clinical trial is conducted

Canada, 

Outcome

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