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Community-Based Maintenance Exercise Program for COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Community-based exercise program
Sponsored by
West Park Healthcare Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, exercise, community

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Trillium Health Partners- Credit Valley Hospital
  • St. Joseph's Care Group
  • West Park Healthcare Centre
  • Lakeridge Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Community Exercise Group

Usual Care

Arm Description

Community-based exercise program for one year

Outcomes

Primary Outcome Measures

Change from baseline in Six Minute Walk Test at 6 months
Change from baseline in Six Minute Walk Test at 12 months

Secondary Outcome Measures

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

Full Information

First Posted
September 4, 2013
Last Updated
July 24, 2018
Sponsor
West Park Healthcare Centre
Collaborators
Ontario Lung Association, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01942499
Brief Title
Community-Based Maintenance Exercise Program for COPD
Official Title
A Randomized Controlled Trial of a Post-rehabilitation Community-based Exercise Program for Individuals With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Park Healthcare Centre
Collaborators
Ontario Lung Association, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, exercise, community

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community Exercise Group
Arm Type
Other
Arm Description
Community-based exercise program for one year
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Community-based exercise program
Primary Outcome Measure Information:
Title
Change from baseline in Six Minute Walk Test at 6 months
Time Frame
Baseline and 6 months
Title
Change from baseline in Six Minute Walk Test at 12 months
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Change from baseline in Chronic Respiratory Disease Questionnaire at 6 months
Time Frame
Baseline and 6 months
Title
Change from baseline in Repeated Chair Stand at 6 months
Time Frame
Baseline and 6 months
Title
Change from baseline in Duke Activity Status Index at 6 months
Time Frame
Baseline and 6 months
Title
Change from baseline in Health Utilities Index at 6 months
Time Frame
Baseline and 6 months
Title
Change in baseline in COPD Self-Efficacy Scale at 6 months
Time Frame
Baseline and 6 months
Title
Change from baseline in Chronic Respiratory Disease Questionnaire at 12 months
Time Frame
Baseline and 12 months
Title
Change from baseline in Duke Activity Status Index at 12 months
Time Frame
Baseline and 12 months
Title
Change from baseline in Health Utilities Index at 12 months
Time Frame
Baseline and 12 months
Title
Change from baseline in Repeated Chair Stand at 12 months
Time Frame
Baseline and 12 months
Title
Change in baseline in COPD Self-Efficacy Scale at 12 months
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Goldstein, MD
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trillium Health Partners- Credit Valley Hospital
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
St. Joseph's Care Group
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7A 4J2
Country
Canada
Facility Name
West Park Healthcare Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 2J5
Country
Canada
Facility Name
Lakeridge Health
City
Whitby
State/Province
Ontario
ZIP/Postal Code
L1N5T2
Country
Canada

12. IPD Sharing Statement

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Community-Based Maintenance Exercise Program for COPD

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