- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02426437
Examining Pulmonary Rehabilitation on Discharged COPD Patients
How Does Early Rehabilitation Affect Patient-centred Health Outcomes and Cardiovascular Risk in COPD Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
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Edmonton, Alberta, Canada, t6g2b7
- University of Alberta Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients admitted to the pulmonary ward for an AECOPD will be offered participation into this arm of the study.
Exclusion Criteria:
- Acute cardiac injury during admission
- Mobility issues
- Residence outside the greater Edmonton area
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Early Pulmonary Rehabilitation (EPR)
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.
|
Patients enrolled in PR will undergo a 6-8 week rehabilitation program.
|
OTHER: Late Pulmonary Rehabilitation (LPR)
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.
|
Patients enrolled in PR will undergo a 6-8 week rehabilitation program.
|
OTHER: Usual Care
Usual care patients will be followed-up by their most responsible physician as determined by the admitting team.
|
Patients enrolled in usual care will be followed-up by their most responsible physician as determined by the admitting team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from Baseline Quality of Life - 1 at 8 weeks and 6 months
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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)
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Change from Baseline Vascular Function at 8 weeks and 6 months
|
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.
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Change from Baseline Central and Peripheral Arterial Stiffness (AS) at 8 weeks and 6 months
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Change in Quality of Life - 2
Time Frame: Change from Baseline Quality of Life - 2 at 8 weeks and 6 months
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Quality of Life - 2 will be assessed using the St. George Respiratory Questionnaire.
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Change from Baseline Quality of Life - 2 at 8 weeks and 6 months
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Change in Quality of Life - 3
Time Frame: Change from Baseline Quality of Life - 3 at 8 weeks and 6 months
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Quality of Life - 3 will be assessed using the COPD Self Efficacy Scale.
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Change from Baseline Quality of Life - 3 at 8 weeks and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Inflammatory marker (IL-6)
Time Frame: Change from Baseline IL-6 at 8 weeks and 6 months
|
IL-6: is an interleukin that acts as both a pro-inflammatory and anti-inflammatory cytokine.
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Change from Baseline IL-6 at 8 weeks and 6 months
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Change in Inflammatory marker (TNF-alpha)
Time Frame: Change from Baseline TNF-alpha at 8 weeks and 6 months
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TNF-alpha
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Change from Baseline TNF-alpha at 8 weeks and 6 months
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Change in Inflammatory Marker (MMP-2)
Time Frame: Change from Baseline MMP-2 at 8 weeks and 6 months
|
MMP-2
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Change from Baseline MMP-2 at 8 weeks and 6 months
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Change in Inflammatory markers (CRP)
Time Frame: Change from Baseline CRP at 8 weeks and 6 months
|
CRP: C-reactive protein is a non-specific serum marker of inflammation (range <8 is normal)
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Change from Baseline CRP at 8 weeks and 6 months
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Change in Dyspnea (breathlessness)
Time Frame: Change from Baseline Dyspnea at 8 weeks and 6 months
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Dyspnea (breathlessness) will be assessed using Modified Medical Research Council Dyspnea Scale (MMRC)
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Change from Baseline Dyspnea at 8 weeks and 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00038838-2
- AIHS-CRIO Project Grant (Other Identifier: Alberta Innovated Health Solutions (AIHS))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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