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Examining Pulmonary Rehabilitation on Discharged COPD Patients

This study is currently recruiting participants.
Verified September 2017 by University of Alberta
Sponsor:
ClinicalTrials.gov Identifier:
NCT02426437
First Posted: April 27, 2015
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Calgary
Information provided by (Responsible Party):
University of Alberta
  Purpose
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.

Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD) Other: Pulmonary Rehabilitation (PR) Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: How Does Early Rehabilitation Affect Patient-centred Health Outcomes and Cardiovascular Risk in COPD Patients

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • Change in Inflammatory marker (TNF-alpha) [ Time Frame: Change from Baseline TNF-alpha at 8 weeks and 6 months ]
    TNF-alpha

  • Change in Inflammatory Marker (MMP-2) [ Time Frame: Change from Baseline MMP-2 at 8 weeks and 6 months ]
    MMP-2

  • 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)

  • Change in Dyspnea (breathlessness) [ Time Frame: Change from Baseline Dyspnea at 8 weeks and 6 months ]
    Dyspnea (breathlessness) will be assessed using Modified Medical Research Council Dyspnea Scale (MMRC)


Estimated Enrollment: 150
Study Start Date: February 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Pulmonary Rehabilitation (PR)
Patients enrolled in PR will undergo a 6-8 week rehabilitation program.
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.
Other: Pulmonary Rehabilitation (PR)
Patients enrolled in PR will undergo a 6-8 week rehabilitation program.
Usual Care
Usual care patients will be followed-up by their most responsible physician as determined by the admitting team.
Other: Usual Care
Patients enrolled in usual care will be followed-up by their most responsible physician as determined by the admitting team.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426437


Contacts
Contact: Michael K Stickland, PhD 780-492-3995 michael.stickland@ualberta.ca
Contact: Desi P Fuhr, MSc 780-492-1121 fuhr@ualberta.ca

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Desi P Fuhr, MSc    780-492-1121    fuhr@ualberta.ca   
Contact: Brian H Rowe, MD, MSc    780-407-6707    brian.rowe@ualberta.ca   
Sub-Investigator: Mohit Bhutani, MD, FRCPC         
Sub-Investigator: Richard Leigh, MD, PhD         
Sub-Investigator: Brian H Rowe, MD, MSc         
Sponsors and Collaborators
University of Alberta
University of Calgary
Investigators
Principal Investigator: Michael K Stickland, PhD University of Alberta
  More Information

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02426437     History of Changes
Other Study ID Numbers: Pro00038838-2
AIHS-CRIO Project Grant ( Other Identifier: Alberta Innovated Health Solutions (AIHS) )
First Submitted: March 17, 2015
First Posted: April 27, 2015
Last Update Posted: September 6, 2017
Last Verified: September 2017

Keywords provided by University of Alberta:
Acute Exacerbation of COPD (AECOPD)
COPD
Emphysema
Chronic Bronchitis

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases


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