Community-Based Maintenance Exercise Program for COPD

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Community-based exercise program

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5M 2N1
      • Trillium Health Partners- Credit Valley Hospital
    • Thunder Bay, Ontario, Canada, P7A 4J2
      • St. Joseph's Care Group
    • Toronto, Ontario, Canada, M6M 2J5
      • West Park Healthcare Centre
    • Whitby, Ontario, Canada, L1N5T2
      • Lakeridge Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Other: Community Exercise Group; Community-based exercise program for one year	Other: Community-based exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Six Minute Walk Test at 6 months	Baseline and 6 months
Change from baseline in Six Minute Walk Test at 12 months	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Chronic Respiratory Disease Questionnaire at 6 months	Baseline and 6 months
Change from baseline in Repeated Chair Stand at 6 months	Baseline and 6 months
Change from baseline in Duke Activity Status Index at 6 months	Baseline and 6 months
Change from baseline in Health Utilities Index at 6 months	Baseline and 6 months
Change in baseline in COPD Self-Efficacy Scale at 6 months	Baseline and 6 months
Change from baseline in Chronic Respiratory Disease Questionnaire at 12 months	Baseline and 12 months
Change from baseline in Duke Activity Status Index at 12 months	Baseline and 12 months
Change from baseline in Health Utilities Index at 12 months	Baseline and 12 months
Change from baseline in Repeated Chair Stand at 12 months	Baseline and 12 months
Change in baseline in COPD Self-Efficacy Scale at 12 months	Baseline and 12 months

Collaborators and Investigators

• Sponsor: West Park Healthcare Centre
• Collaborators: Canadian Institutes of Health Research (CIHR); Ontario Lung Association
• Investigators: Principal Investigator: Roger Goldstein, MD, West Park Healthcare Centre

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: September 4, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimate): September 16, 2013

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: COPD, exercise, community
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 12-006-WP