- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02875522
The Effects of Aerobic Exercise Training on Vascular, Cardiac and Cerebral Vascular Function in COPD
August 17, 2016 updated by: University of British Columbia
The Effects of Aerobic Exercise Training on Peripheral Vascular, Cardiac and Cerebral Vascular Function in Patients With Chronic Obstructive Pulmonary Disease
The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to inflammation in the lungs and blood vessels that can lead to secondary problems such as blood vessel disease, high blood pressure and heart disease.
Aerobic exercise training has been shown to reduce the risk of heart and brain disease; however, it is currently unknown whether exercise training can have the same affect in patients with COPD.
The aim of this study is to investigate how eight weeks of aerobic exercise training improves blood vessel and heart function and brain blood flow in patients with COPD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a treatable respiratory condition that is only partially reversible.
The primary cause of COPD is smoking which leads to airway inflammation and oxidative damage to the lungs, which has been linked to the development and progression of the disease.
The inflammation is not isolated to the lungs as patients with COPD also have systemic inflammation that has been linked to a number of cardiovascular comorbidities such as endothelial dysfunction, cardiovascular disease and stroke.
Evidence demonstrates that COPD patients have a greater incidence of vascular dysfunction and adverse vascular remodeling, which worsens with disease severity.
In fact, patients with COPD are at 35 times greater risk of developing cardiovascular disease and stroke than healthy aged matched individuals.
In healthy individuals and a number of chronic conditions, aerobic exercise training is well established to reduce the risk of cardiovascular and cerebrovascular disease.
The benefits of exercise are likely through improvements in endothelial function, systemic inflammation, and cardiac and cerebral vascular function.
However, whether exercise training can have the same effects in a chronic inflammatory condition like COPD has not been studied.
The purpose of this study is to determine the effectiveness of an 8 week aerobic exercise training program in patient's chronic obstructive pulmonary disease as determined by improvements in endothelial function, systemic inflammation and cardiac and cerebral vascular function.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
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Kelowna, British Columbia, Canada, V1V 1V7
- University of British Columbia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non-smokers (>6 months);
- Forced expiratory volume in one second/ forced vital capacity (FEV1/FVC) < 0.7 and FEV1/FVC <lower limit of normal
- Stable (>3 months exacerbation free)
Exclusion Criteria:
- On supplemental oxygen;
- Known cardiac or cerebral vascular disease, diabetes, obstructive sleep apnea;
- Uncontrolled hypertension;
- BMI >30kg/m2
- Currently performing pulmonary rehabilitation or structured exercise training;
- Desaturate during exercise (SpO2<85%)
- Cardiovascular contraindications to exercise in the incremental test used for screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with COPD
Stable patients with COPD participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.
|
Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank.
Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation
|
|
Active Comparator: Healthy Controls
Age, sex, BMI and activity matched controls participated in an 8-week (24 session) individualized, non-linear aerobic exercise training program consisting of upper and lower body cycle ergometry.
|
Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank.
Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endothelial Function
Time Frame: 8-weeks (following 24 sessions of exercise training)
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The change in brachial artery flow mediated dilation measured using reactive hyperaemia
|
8-weeks (following 24 sessions of exercise training)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial Stiffness
Time Frame: 8-weeks (following 24 sessions of exercise training)
|
The change in pulse wave velocity measured using tonometry
|
8-weeks (following 24 sessions of exercise training)
|
|
Carotid intima-medial thickness
Time Frame: 8-weeks (following 24 sessions of exercise training)
|
The change in carotid intima-medial thickness measured by ultrasound
|
8-weeks (following 24 sessions of exercise training)
|
|
Carotid Compliance
Time Frame: 8-weeks (following 24 sessions of exercise training)
|
The change in carotid compliance measured using tonometry and ultrasound for the carotid arteries
|
8-weeks (following 24 sessions of exercise training)
|
|
Inflammatory Biomarkers
Time Frame: 8-weeks (following 24 sessions of exercise training)
|
The change in serum levels of CRP, IL-6, IL-10 and TNF-alpha measured using Luminex multiplex bead-based technology
|
8-weeks (following 24 sessions of exercise training)
|
|
Systolic function
Time Frame: 8-weeks (following 24 sessions of exercise training)
|
The change in stroke volume using echocardiography
|
8-weeks (following 24 sessions of exercise training)
|
|
Diastolic function
Time Frame: 8-weeks (following 24 sessions of exercise training)
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The change in left ventricular end-diastolic volume using echocardiography
|
8-weeks (following 24 sessions of exercise training)
|
|
Cerebral Blood Flow
Time Frame: 8-weeks (following 24 sessions of exercise training)
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The change in cerebral and neck blood flow using ultrasound
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8-weeks (following 24 sessions of exercise training)
|
|
Cerebrovascular Reactivity
Time Frame: 8-weeks (following 24 sessions of exercise training)
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The change in middle cerebral artery velocity in response to carbon dioxide
|
8-weeks (following 24 sessions of exercise training)
|
|
Cerebrovascular Autoregulation
Time Frame: 8-weeks (following 24 sessions of exercise training)
|
The change in phase delay measured by transfer function analysis
|
8-weeks (following 24 sessions of exercise training)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil Eves, PhD, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gelinas JC, Lewis NC, Harper MI, Ainslie PN, Rolf JD, Eves ND. Aerobic Exercise Training on Peripheral Vascular Structure and Function in Patients with Chronic Obstructive Pulmonary Disease. American Journal of Respiratory and Critical Care Medicine, 191:A5305, 2015.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
August 4, 2016
First Submitted That Met QC Criteria
August 17, 2016
First Posted (Estimate)
August 23, 2016
Study Record Updates
Last Update Posted (Estimate)
August 23, 2016
Last Update Submitted That Met QC Criteria
August 17, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H11-02770
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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