Community-Based Maintenance Exercise Program for COPD

NCT01942499 | Completed

• 1 other identifier: 12-006-WP
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, exercise, community

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

Study Arms (2)

Community Exercise Group

OTHER

Community-based exercise program for one year

Other: Community-based exercise program

Usual Care

NO INTERVENTION

Interventions

Community-based exercise program OTHER

Community Exercise Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Park Healthcare Centre: lead
• Ontario Lung Association: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Trillium Health Partners- Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

St. Joseph's Care Group

Thunder Bay, Ontario, P7A 4J2, Canada

Location

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

Lakeridge Health

Whitby, Ontario, L1N5T2, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Roger Goldstein, MD

  West Park Healthcare Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respirologist

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 16, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

CA (4)