Chronic Obstructive Pulmonary DiseaseNCT01942499
Community-Based Maintenance Exercise Program for COPD
A study testing Community-based exercise program in people with Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre at 4 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Community-based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 4 sitesCanada
- Study dates
- Nov 2012to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Trillium Health Partners- Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
St. Joseph's Care Group
Thunder Bay, Ontario, P7A 4J2
West Park Healthcare Centre
Toronto, Ontario, M6M 2J5
Lakeridge Health
Whitby, Ontario, L1N5T2
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Community-based exercise program
- Keywords
- COPD, exercise, community
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based exercise programOther
| Study group | Role | What they receive |
|---|---|---|
| Community Exercise Group | Other | Community-based exercise program for one year Receives: Other: Community-based exercise program |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Six Minute Walk Test at 6 months
Measured: Baseline and 6 months
Change from baseline in Six Minute Walk Test at 12 months
Measured: Baseline and 12 months
Secondary outcomes (10)
Change from baseline in Chronic Respiratory Disease Questionnaire at 6 months
Measured: Baseline and 6 months
Change from baseline in Repeated Chair Stand at 6 months
Measured: Baseline and 6 months
Change from baseline in Duke Activity Status Index at 6 months
Measured: Baseline and 6 months
Change from baseline in Health Utilities Index at 6 months
Measured: Baseline and 6 months
Change in baseline in COPD Self-Efficacy Scale at 6 months
Measured: Baseline and 6 months
Change from baseline in Chronic Respiratory Disease Questionnaire at 12 months
Measured: Baseline and 12 months
Change from baseline in Duke Activity Status Index at 12 months
Measured: Baseline and 12 months
Change from baseline in Health Utilities Index at 12 months
Measured: Baseline and 12 months
Change from baseline in Repeated Chair Stand at 12 months
Measured: Baseline and 12 months
Change in baseline in COPD Self-Efficacy Scale at 12 months
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startNov 2012
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Lung Association, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Roger Goldstein, West Park Healthcare Centre
- Investigators
- Roger Goldstein, MD, Principal investigator, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942499
- Sponsor's protocol ID
- 12-006-WP
- Status last verified
- Jul 2018
- First submitted
- 4 Sep 2013
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Post-rehabilitation Community-based Exercise Program for Individuals With COPD
- ClinicalTrials.gov ID
- NCT01942499
- Acronym / sponsor ID
- 12-006-WP
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, exercise, community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Collaborators
- Ontario Lung Association, Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2012
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Exercise Group | Other | Other: Community-based exercise programCommunity-based exercise program for one year |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based exercise program | Other | Community Exercise Group |
Primary outcome
Change from baseline in Six Minute Walk Test at 6 months
Time frame: Baseline and 6 months
Change from baseline in Six Minute Walk Test at 12 months
Time frame: Baseline and 12 months
10 secondary outcomes
Change from baseline in Chronic Respiratory Disease Questionnaire at 6 months
Time frame: Baseline and 6 months
Change from baseline in Repeated Chair Stand at 6 months
Time frame: Baseline and 6 months
Change from baseline in Duke Activity Status Index at 6 months
Time frame: Baseline and 6 months
Change from baseline in Health Utilities Index at 6 months
Time frame: Baseline and 6 months
Change in baseline in COPD Self-Efficacy Scale at 6 months
Time frame: Baseline and 6 months
Change from baseline in Chronic Respiratory Disease Questionnaire at 12 months
Time frame: Baseline and 12 months
Change from baseline in Duke Activity Status Index at 12 months
Time frame: Baseline and 12 months
Change from baseline in Health Utilities Index at 12 months
Time frame: Baseline and 12 months
Change from baseline in Repeated Chair Stand at 12 months
Time frame: Baseline and 12 months
Change in baseline in COPD Self-Efficacy Scale at 12 months
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Goldstein, MD principal investigator
West Park Healthcare Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based exercise program in people with Chronic Obstructive Pulmonary Disease, run by West Park Healthcare Centre at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Six Minute Walk Test at 6 months (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.