Examining Vascular Outcomes in COPD Inpatients (AIM 1) Examining Early Rehabilitation on Discharged COPD Patients (AIM 2)

NCT01949727 | Completed

• 2 other identifiers: Pro00038838AIHS-CRIO Project Grant
• Study Type: observational
• Target: 111
• 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 have 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 typical inpatient COPD care, and how early referral to chronic disease management programs after hospital discharge, affect patient outcomes. This grant brings together an outstanding group of researchers who have the necessary clinical, content and methodological expertise to successfully complete this work. These studies will provide invaluable information about inpatient and outpatient management for a disease which has a tremendous impact on healthcare.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

AECOPD; COPD; Emphysema; Chronic bronchitis

Outcome Measures

Primary Outcomes (3)

• Change in Inflammatory markers

  CRP: C-reactive protein is a non-specific serum marker of inflammation (range \<8 is normal)

  within 24 hours of Admission, within 24 hours of hospital discharge, 14 day follow up

• Change in Vascular Function

  Vascular Function assessed using EndoPat; RHI: Reactive Hyperemia Index

  Within 24 hours of Admission, within 24 hours of hospital discharge, 14 day follow up

• Change in Arterial Stiffness

  Pulse wave velocity assessed using Complior

  Within 24 hours of Admission, within 24 hours of hospital discharge, 14 day follow up

Secondary Outcomes (11)

• Length of Stay (LOS)

  up to 30 days

• Readmission-All Cause

  up to 1 year

• Readmission-AECOPD

  up to 1 year

• Change in Physical Activity

  Within 24 hours of Admission, within 24 hours of hospital discharge, 14 day follow up

• Change in Inflammatory marker (IL-6)

  Within 24 hours of Admission, within 24 hours of hospital discharge, 14 day follow up

Study Arms (1)

AIM 1/AIM 2: AECOPD Admitted Patients

AIM 1:All patients admitted to the hospital (either to Pulmonary or General Medicine) will be recruited to enroll in this observational study. No specific intervention is planned for this group. AIM 2: All patients admitted to the pulmonary ward for an AECOPD, including those who have completed Aim 1, will be offered participation into this arm of the study. Pulmonary rehabilitation will be conducted through the Breathe Easy Program at the Centre for Lung Health.

Other: AIM 2: Pulmonary Rehabilitation

Interventions

AIM 2: Pulmonary Rehabilitation OTHER

Patients exercise 2 hours per session which includes aerobic exercise (20-40 minutes per session) as well as strength training. All exercise is carefully tracked by trained Respiratory or Physical Therapists. Patients also receive education from a multi-disciplinary team aimed at patient self-management.

AIM 1/AIM 2: AECOPD Admitted Patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes all English-speaking patients who are admitted to a Pulmonary ward with a diagnosis of Acute Exacerbation of COPD after presenting to ED.

You may not qualify if:

• Age \>85
• Cancer Diagnosis/Treatment
• End Stage/Palliative Care
• Dementia
• Hypoxia or respiratory failure impacting ability to consent
• Troponin \>1.0
• BNP \> 500
• AECOPD not primary diagnosis
• Not admitted to hospital
• Language barrier
• Barriers to follow up
• NOTE: Patients with dementia and difficulty with communicating in English are excluded because the questionnaires used have only been validated in English-speaking coherent patients.
• AIM 2:
• \- Diagnosis of AECOPD who are admitted to the pulmonary ward at the University of Alberta Hospital
• Age \>85

Sponsors & Collaborators

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

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

• Fuhr DP, Brotto AR, Rowe BH, Bhutani M, Rosychuk RJ, Stickland MK. Examining changes in vascular function, arterial stiffness and systemic inflammation during hospitalization and recovery from an acute exacerbation of chronic obstructive pulmonary disease. Sci Rep. 2023 Jul 28;13(1):12245. doi: 10.1038/s41598-023-39001-z.

  PMID: 37507427 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

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 Stickland, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 24, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

CA (1)