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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by University of Alberta
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
Michael Stickland, University of Alberta
ClinicalTrials.gov Identifier:
NCT01949727
First received: September 20, 2013
Last updated: March 3, 2017
Last verified: March 2017
  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 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.

Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Other: AIM 2: Pulmonary Rehabilitation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: COPD Hospitalization:Examining Pulmonary and Cardiovascular Outcomes in Chronic Obstructive Pulmonary Disease Inpatients (AIM 1). COPD Rehabilitation:Examining the Impact of Early Pulmonary Rehabilitation on Discharged COPD Patients (AIM 2)

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Inflammatory markers [ Time Frame: 14 days ]
    CRP: C-reactive protein is a non-specific serum marker of inflammation (range <8 is normal)


Secondary Outcome Measures:
  • Length of Stay (LOS) [ Time Frame: up to 30 days ]
    Length of stay in the hospital to the point where the patient is stable from the COPD perspective. Patients with LTC needs may stay beyond the designated hospitalization due to care needs.

  • Inflammatory marker (IL-6) [ Time Frame: 14 days ]
    IL-6: is an interleukin that acts as both a pro-inflammatory and anti-inflammatory cytokine.

  • Inflammatory marker (TNF-alpha) [ Time Frame: 14 days ]
    TNF-alpha

  • Inflammatory Marker (MMP-2) [ Time Frame: 14 days ]
    MMP-2

  • Quality of Life (QoL) [ Time Frame: 14 days ]
    CAT MMRC SGHRQ


Biospecimen Retention:   Samples Without DNA
Blood

Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

AIM 1:

All patients with a diagnosis of AECOPD who are admitted to the pulmonary ward at the University of Alberta Hospital will be screened for enrollment.

Patients with evidence of significant cardiac disease/injury (i.e. BNP >500 pg/ml and Troponin >1.0 mcg/L) will be excluded. Further, patients requiring ventilatory support in the form of non-invasive ventilation (NIV), will not be recruited.

The study is focused on examining how treatment for AECOPD affects cardiovascular/health outcomes. While it is acknowledged that there is significant cross-over in those with COPD and heart disease, we are restricting enrollment to those who have AECOPD as their primary reason for hospitalization.

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:

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.

Patients found to have an acute cardiac injury during admission, mobility issues or residence outside the greater Edmonton area will be excluded.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949727

Contacts
Contact: Michael Stickland, PhD 780-407-7845 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, T6G 2B7
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 Stickland, PhD University of Alberta
  More Information

Responsible Party: Michael Stickland, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01949727     History of Changes
Other Study ID Numbers: Pro00038838
AIHS-CRIO Project Grant ( Other Identifier: Alberta Innovated Health Solutions (AIHS) )
Study First Received: September 20, 2013
Last Updated: March 3, 2017

Keywords provided by University of Alberta:
AECOPD
COPD
Emphysema
Chronic bronchitis

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

ClinicalTrials.gov processed this record on March 24, 2017