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Completed

NCT Number: NCT01942499

Community-Based Maintenance Exercise Program for 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trillium Health Partners- Credit Valley Hospital, Mississauga, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community-based exercise program

Other

Primary outcomes

  1. Change from baseline in Six Minute Walk Test at 6 months

    Time frame: Baseline and 6 months

  2. Change from baseline in Six Minute Walk Test at 12 months

    Time frame: Baseline and 12 months

Secondary outcomes

  1. Change from baseline in Chronic Respiratory Disease Questionnaire at 6 months

    Time frame: Baseline and 6 months

  2. Change from baseline in Repeated Chair Stand at 6 months

    Time frame: Baseline and 6 months

  3. Change from baseline in Duke Activity Status Index at 6 months

    Time frame: Baseline and 6 months

  4. Change from baseline in Health Utilities Index at 6 months

    Time frame: Baseline and 6 months

  5. Change in baseline in COPD Self-Efficacy Scale at 6 months

    Time frame: Baseline and 6 months

  6. Change from baseline in Chronic Respiratory Disease Questionnaire at 12 months

    Time frame: Baseline and 12 months

  7. Change from baseline in Duke Activity Status Index at 12 months

    Time frame: Baseline and 12 months

  8. Change from baseline in Health Utilities Index at 12 months

    Time frame: Baseline and 12 months

  9. Change from baseline in Repeated Chair Stand at 12 months

    Time frame: Baseline and 12 months

  10. Change in baseline in COPD Self-Efficacy Scale at 12 months

    Time frame: Baseline and 12 months

Sponsors and collaborators

Lead sponsor

West Park Healthcare Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Ontario Lung Association

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2013
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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