COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT01949727
Recruitment Status : Recruiting
First Posted : September 24, 2013
Last Update Posted : October 7, 2019
University of Calgary
Information provided by (Responsible Party):
Michael Stickland, University of Alberta

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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease (COPD) Other: AIM 2: Pulmonary Rehabilitation

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
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)
Study Start Date : October 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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.

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

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

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

  5. Quality of Life (QoL) [ Time Frame: 14 days ]

Biospecimen Retention:   Samples Without DNA

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.

Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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.

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.

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 identifier (NCT number): NCT01949727

Layout table for location contacts
Contact: Michael Stickland, PhD 780-407-7845
Contact: Desi P Fuhr, MSc 780-492-1121

Layout table for location information
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Desi P Fuhr, MSc    780-492-1121   
Contact: Brian H Rowe, MD, MSc    780-407-6707`   
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
Layout table for investigator information
Principal Investigator: Michael Stickland, PhD University of Alberta

Layout table for additonal information
Responsible Party: Michael Stickland, Assistant Professor, University of Alberta Identifier: NCT01949727    
Other Study ID Numbers: Pro00038838
AIHS-CRIO Project Grant ( Other Identifier: Alberta Innovated Health Solutions (AIHS) )
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Keywords provided by Michael Stickland, University of Alberta:
Chronic bronchitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases