Chronic Obstructive Pulmonary Disease (COPD)NCT02426437
Examining Pulmonary Rehabilitation on Discharged COPD Patients
A study testing Pulmonary Rehabilitation (PR) in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Alberta at 1 site in Canada.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations result in frequent, prolonged hospitalizations. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Pulmonary Rehabilitation (PR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Dec 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to the pulmonary ward for an AECOPD will be offered participation into this arm of the study.
Who cannot join
- Acute cardiac injury during admission
- Mobility issues
- Residence outside the greater Edmonton area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Does Early Rehabilitation Affect Patient-centred Health Outcomes and Cardiovascular Risk in COPD Patients
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations result in frequent, prolonged hospitalizations. While originally considered a disease specific to the lung, data has shown that COPD is associated with substantial cardiovascular (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown; however, it may be due to chronic inflammation which is exacerbated with a flare-up of the disease, and/or chronic inactivity which is similarly worsened with bed-rest during a hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk. Disease management programs, such as pulmonary rehabilitation and patient self-management education, are part of guideline therapy for COPD; however, these are not regularly implemented following a hospitalization, and how these interventions affect patient outcomes, behavior, physical activity, inflammation and CV risk have not been well studied. The proposed long-term project will examine how early referral to chronic disease management programs after hospital discharge, affect patient outcomes. This study will provide invaluable information about outpatient management for a disease which has a tremendous impact on healthcare.
Read the detailed description
Purpose: To examine the impact of early pulmonary rehabilitation (PR) following hospital discharge on QoL, pulmonary/CV outcomes and AECOPD hospitalizations.
Rationale: In addition to typical improvements in QoL and exercise tolerance, studies have shown that PR increases self-efficacy and physical activity while reducing CV risk in stable COPD patients. Patients recently discharge from hospital following AECOPD represent the sickest patients with greatly reduced QoL, exercise tolerance, self-efficacy and physical activity. Exactly how these improve with PR following a hospitalization requires examination.
Hypothesis: Patients who receive early PR will have improved QoL, pulmonary/CV outcomes and less hospitalizations for COPD in the 6 months following hospital discharge. PR will improve self efficacy, physical activity and QoL while reducing CV risk as compared to usual care.
Study Design \& Subject Recruitment: All patients admitted to the pulmonary ward for an AECOPD, will be offered participation into the study. Patients found to have an acute cardiac injury during admission, mobility issues or residence outside the greater Edmonton area will be excluded. Consenting patients will be subsequently randomized into one of three groups: early PR versus late PR versus usual care. Patients randomized to PR will be enrolled within 1 (Early PR; EPR) or 3 months (Late PR; LPR) of discharge into a PR program. Usual care patients will be followed-up by their most responsible physician as determined by the admitting team. The PR group will be enrolled in the Breathe Easy Program at the Center for Lung Health, and will proceed through the program in a typical fashion. All patients will be followed up 6 months after discharge and will be interviewed to assess disease status, management review and if there has been a history of recurrence or relapse of the AECOPD. Hospital admissions and length of stay data will be obtained through electronic medical records. Patient assessments will include: quality of life, 6min walk, dyspnea, self-efficacy, physical activity, pulse wave velocity, vascular function, systemic inflammation (TNFα, MMP-2, IL-6 and CRP) and FeNO. All data will be collected before, immediately after and 6 months after PR. The control group will have the same data collected at the same scheduled time. See above for descriptions of methods.
Data Handling: Data will be entered onto a secure anonymized database.
Data Analysis: The influence of PR on QoL, 6min walk, dyspnea, self-efficacy, physical activity, pulse wave velocity, vascular function, systemic inflammation and eNO will be analyzed using a multivariate mixed-model MANOVA with treatment (Early-PR vs. Late-PR vs. usual care) being a fixed between-group variable and time (pre, immediate post, 6months post) as a repeated variable.
Sample size: Based on previous work, a sample size of 50 in each group (150 total) will be sufficient to detect a between-group differences in QoL, 6min walk, PWV, dyspnea and hospital readmission rates following PR (α=0.05, β=0.8). Based on the investigators recent work, this sample could detect a 10% difference in physical activity following PR (α=0.05, β=0.8). One hundred fifty patients will also allow for stratification of physiological and psychological responses with PR.
- Being tested
- Pulmonary Rehabilitation (PR), Usual Care
- Keywords
- Acute Exacerbation of COPD (AECOPD), COPD, Emphysema, Chronic Bronchitis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Rehabilitation (PR)Other
Patients enrolled in PR will undergo a 6-8 week rehabilitation program.
Usual CareOther
Patients enrolled in usual care will be followed-up by their most responsible physician as determined by the admitting team.
| Study group | Role | What they receive |
|---|---|---|
| Early Pulmonary Rehabilitation (EPR) | Other | Patients randomized to EPR will be enrolled into the Breath Easy pulmonary rehabilitation (PR) program at the Centre for Lung Health within 1 month of discharge. They will proceed through the program in a typical fashion. Receives: Other: Pulmonary Rehabilitation (PR) |
| Late Pulmonary Rehabilitation (LPR) | Other | Patients randomized to LPR will be enrolled into the Breath Easy pulmonary rehabilitation (PR) program at the Centre for Lung Health within 3 months of discharge. They will proceed through the program in a typical fashion. Receives: Other: Pulmonary Rehabilitation (PR) |
| Usual Care | Other | Usual care patients will be followed-up by their most responsible physician as determined by the admitting team. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life - 1
Quality of Life - 1 will be assessed using the COPD Assessment tool.
Measured: Change from Baseline Quality of Life - 1 at 8 weeks and 6 months
Change in Vascular Function
Vascular function will be assessed using peripheral arterial tone (PAT)
Measured: Change from Baseline Vascular Function at 8 weeks and 6 months
Change in Central and Peripheral Arterial Stiffness (AS)
Arterial Stiffness will be assessed using pulse wave velocity measured from the carotid and femoral (central) and carotid and radial (peripheral) arteries.
Measured: Change from Baseline Central and Peripheral Arterial Stiffness (AS) at 8 weeks and 6 months
Change in Quality of Life - 2
Quality of Life - 2 will be assessed using the St. George Respiratory Questionnaire.
Measured: Change from Baseline Quality of Life - 2 at 8 weeks and 6 months
Change in Quality of Life - 3
Quality of Life - 3 will be assessed using the COPD Self Efficacy Scale.
Measured: Change from Baseline Quality of Life - 3 at 8 weeks and 6 months
Secondary outcomes (5)
Change in Inflammatory marker (IL-6)
IL-6: is an interleukin that acts as both a pro-inflammatory and anti-inflammatory cytokine.
Measured: Change from Baseline IL-6 at 8 weeks and 6 months
Change in Inflammatory marker (TNF-alpha)
TNF-alpha
Measured: Change from Baseline TNF-alpha at 8 weeks and 6 months
Change in Inflammatory Marker (MMP-2)
MMP-2
Measured: Change from Baseline MMP-2 at 8 weeks and 6 months
Change in Inflammatory markers (CRP)
CRP: C-reactive protein is a non-specific serum marker of inflammation (range <8 is normal)
Measured: Change from Baseline CRP at 8 weeks and 6 months
Change in Dyspnea (breathlessness)
Dyspnea (breathlessness) will be assessed using Modified Medical Research Council Dyspnea Scale (MMRC)
Measured: Change from Baseline Dyspnea at 8 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
- Investigators
- Michael K Stickland, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426437
- Sponsor's protocol ID
- Pro00038838-2
- Other IDs
- AIHS-CRIO Project Grant
- Status last verified
- Apr 2021
- First submitted
- 17 Mar 2015
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Early Rehabilitation Affect Patient-centred Health Outcomes and Cardiovascular Risk in COPD Patients
- ClinicalTrials.gov ID
- NCT02426437
- Acronym / sponsor ID
- Pro00038838-2
- Keywords
- Acute Exacerbation of COPD (AECOPD), COPD, Emphysema, Chronic Bronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 27 Apr 2015 (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.
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations result in frequent, prolonged hospitalizations. While originally considered a disease specific to the lung, data has shown that COPD is associated with substantial cardiovascular (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown; however, it may be due to chronic inflammation which is exacerbated with a flare-up of the disease, and/or chronic inactivity which is similarly worsened with bed-rest during a hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk. Disease management programs, such as pulmonary rehabilitation and patient self-management education, are part of guideline therapy for COPD; however, these are not regularly implemented following a hospitalization, and how these interventions affect patient outcomes, behavior, physical activity, inflammation and CV risk have not been well studied. The proposed long-term project will examine how early referral to chronic disease management programs after hospital discharge, affect patient outcomes. This study will provide invaluable information about outpatient management for a disease which has a tremendous impact on healthcare.
Detailed description
Purpose: To examine the impact of early pulmonary rehabilitation (PR) following hospital discharge on QoL, pulmonary/CV outcomes and AECOPD hospitalizations.
Rationale: In addition to typical improvements in QoL and exercise tolerance, studies have shown that PR increases self-efficacy and physical activity while reducing CV risk in stable COPD patients. Patients recently discharge from hospital following AECOPD represent the sickest patients with greatly reduced QoL, exercise tolerance, self-efficacy and physical activity. Exactly how these improve with PR following a hospitalization requires examination.
Hypothesis: Patients who receive early PR will have improved QoL, pulmonary/CV outcomes and less hospitalizations for COPD in the 6 months following hospital discharge. PR will improve self efficacy, physical activity and QoL while reducing CV risk as compared to usual care.
Study Design \& Subject Recruitment: All patients admitted to the pulmonary ward for an AECOPD, will be offered participation into the study. Patients found to have an acute cardiac injury during admission, mobility issues or residence outside the greater Edmonton area will be excluded. Consenting patients will be subsequently randomized into one of three groups: early PR versus late PR versus usual care. Patients randomized to PR will be enrolled within 1 (Early PR; EPR) or 3 months (Late PR; LPR) of discharge into a PR program. Usual care patients will be followed-up by their most responsible physician as determined by the admitting team. The PR group will be enrolled in the Breathe Easy Program at the Center for Lung Health, and will proceed through the program in a typical fashion. All patients will be followed up 6 months after discharge and will be interviewed to assess disease status, management review and if there has been a history of recurrence or relapse of the AECOPD. Hospital admissions and length of stay data will be obtained through electronic medical records. Patient assessments will include: quality of life, 6min walk, dyspnea, self-efficacy, physical activity, pulse wave velocity, vascular function, systemic inflammation (TNFα, MMP-2, IL-6 and CRP) and FeNO. All data will be collected before, immediately after and 6 months after PR. The control group will have the same data collected at the same scheduled time. See above for descriptions of methods.
Data Handling: Data will be entered onto a secure anonymized database.
Data Analysis: The influence of PR on QoL, 6min walk, dyspnea, self-efficacy, physical activity, pulse wave velocity, vascular function, systemic inflammation and eNO will be analyzed using a multivariate mixed-model MANOVA with treatment (Early-PR vs. Late-PR vs. usual care) being a fixed between-group variable and time (pre, immediate post, 6months post) as a repeated variable.
Sample size: Based on previous work, a sample size of 50 in each group (150 total) will be sufficient to detect a between-group differences in QoL, 6min walk, PWV, dyspnea and hospital readmission rates following PR (α=0.05, β=0.8). Based on the investigators recent work, this sample could detect a 10% difference in physical activity following PR (α=0.05, β=0.8). One hundred fifty patients will also allow for stratification of physiological and psychological responses with PR.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Pulmonary Rehabilitation (EPR) | Other | Other: Pulmonary Rehabilitation (PR)Patients randomized to EPR will be enrolled into the Breath Easy pulmonary rehabilitation (PR) program at the Centre for Lung Health within 1 month of discharge. They will proceed through the program in a typical fashion. |
| Late Pulmonary Rehabilitation (LPR) | Other | Other: Pulmonary Rehabilitation (PR)Patients randomized to LPR will be enrolled into the Breath Easy pulmonary rehabilitation (PR) program at the Centre for Lung Health within 3 months of discharge. They will proceed through the program in a typical fashion. |
| Usual Care | Other | Other: Usual CareUsual care patients will be followed-up by their most responsible physician as determined by the admitting team. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the pulmonary ward for an AECOPD will be offered participation into this arm of the study.
Key exclusion criteria (3 listed)
- Acute cardiac injury during admission
- Mobility issues
- Residence outside the greater Edmonton area
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 |
|---|---|---|
| Pulmonary Rehabilitation (PR)Patients enrolled in PR will undergo a 6-8 week rehabilitation program. | Other | Early Pulmonary Rehabilitation (EPR), Late Pulmonary Rehabilitation (LPR) |
| Usual CarePatients enrolled in usual care will be followed-up by their most responsible physician as determined by the admitting team. | Other | Usual Care |
Primary outcome
Change in Quality of Life - 1
Time frame: Change from Baseline Quality of Life - 1 at 8 weeks and 6 months
Quality of Life - 1 will be assessed using the COPD Assessment tool.
Change in Vascular Function
Time frame: Change from Baseline Vascular Function at 8 weeks and 6 months
Vascular function will be assessed using peripheral arterial tone (PAT)
Change in Central and Peripheral Arterial Stiffness (AS)
Time frame: Change from Baseline Central and Peripheral Arterial Stiffness (AS) at 8 weeks and 6 months
Arterial Stiffness will be assessed using pulse wave velocity measured from the carotid and femoral (central) and carotid and radial (peripheral) arteries.
Change in Quality of Life - 2
Time frame: Change from Baseline Quality of Life - 2 at 8 weeks and 6 months
Quality of Life - 2 will be assessed using the St. George Respiratory Questionnaire.
Change in Quality of Life - 3
Time frame: Change from Baseline Quality of Life - 3 at 8 weeks and 6 months
Quality of Life - 3 will be assessed using the COPD Self Efficacy Scale.
5 secondary outcomes
Change in Inflammatory marker (IL-6)
Time frame: Change from Baseline IL-6 at 8 weeks and 6 months
Change in Inflammatory marker (TNF-alpha)
Time frame: Change from Baseline TNF-alpha at 8 weeks and 6 months
Change in Inflammatory Marker (MMP-2)
Time frame: Change from Baseline MMP-2 at 8 weeks and 6 months
Change in Inflammatory markers (CRP)
Time frame: Change from Baseline CRP at 8 weeks and 6 months
Change in Dyspnea (breathlessness)
Time frame: Change from Baseline Dyspnea at 8 weeks and 6 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 8 Apr 2021.
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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.
Michael K Stickland, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation (PR) in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Alberta at 1 site 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 1 inclusion and 3 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 in Quality of Life - 1 (time frame: Change from Baseline Quality of Life - 1 at 8 weeks and 6 months). The study lists 5 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 8 Apr 2021.