Examining Pulmonary Rehabilitation on Discharged COPD Patients

NCT02426437 | Completed

• 2 other identifiers: Pro00038838-2AIHS-CRIO Project Grant
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Acute Exacerbation of COPD (AECOPD); COPD; Emphysema; Chronic Bronchitis

Outcome Measures

Primary Outcomes (5)

• Change in Quality of Life - 1

  Quality of Life - 1 will be assessed using the COPD Assessment tool.

  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)

  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.

  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.

  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.

  Change from Baseline Quality of Life - 3 at 8 weeks and 6 months

Secondary Outcomes (5)

• Change in Inflammatory marker (IL-6)

  Change from Baseline IL-6 at 8 weeks and 6 months

• Change in Inflammatory marker (TNF-alpha)

  Change from Baseline TNF-alpha at 8 weeks and 6 months

• Change in Inflammatory Marker (MMP-2)

  Change from Baseline MMP-2 at 8 weeks and 6 months

• Change in Inflammatory markers (CRP)

  Change from Baseline CRP at 8 weeks and 6 months

• Change in Dyspnea (breathlessness)

  Change from Baseline Dyspnea at 8 weeks and 6 months

Study Arms (3)

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.

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.

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.

Other: Usual Care

Interventions

Pulmonary Rehabilitation (PR) OTHER

Patients enrolled in PR will undergo a 6-8 week rehabilitation program.

Early Pulmonary Rehabilitation (EPR); Late Pulmonary Rehabilitation (LPR)

Usual Care OTHER

Patients enrolled in usual care will be followed-up by their most responsible physician as determined by the admitting team.

Usual Care

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to the pulmonary ward for an AECOPD will be offered participation into this arm of the study.

You may not qualify if:

• Acute cardiac injury during admission
• Mobility issues
• Residence outside the greater Edmonton area

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Michael K Stickland, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: April 27, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

CA (1)