Examining Pulmonary Rehabilitation on Discharged COPD Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive
Study type: Interventional

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. 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.
    

Intervention name(s): Pulmonary Rehabilitation (PR); Usual Care
Intervention type(s): Other; Other
Intervention description(s): Patients enrolled in PR will undergo a 6-8 week rehabilitation program.; Patients enrolled in usual care will be followed-up by their most responsible physician as determined by the admitting team.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Acute Exacerbation of COPD (AECOPD); COPD; Emphysema; Chronic Bronchitis