The Effects of Aerobic Exercise Training on Vascular, Cardiac and Cerebral Vascular Function in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Individualized, non-linear aerobic exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Exercise Training, Flow-Mediated Dilation, Arterial Stiffness, Echocardiography, Cerebrovascular Physiology
Eligibility Criteria
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
Sites / Locations
- University of British Columbia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with COPD
Healthy Controls
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Endothelial Function
The change in brachial artery flow mediated dilation measured using reactive hyperaemia
Secondary Outcome Measures
Arterial Stiffness
The change in pulse wave velocity measured using tonometry
Carotid intima-medial thickness
The change in carotid intima-medial thickness measured by ultrasound
Carotid Compliance
The change in carotid compliance measured using tonometry and ultrasound for the carotid arteries
Inflammatory Biomarkers
The change in serum levels of CRP, IL-6, IL-10 and TNF-alpha measured using Luminex multiplex bead-based technology
Systolic function
The change in stroke volume using echocardiography
Diastolic function
The change in left ventricular end-diastolic volume using echocardiography
Cerebral Blood Flow
The change in cerebral and neck blood flow using ultrasound
Cerebrovascular Reactivity
The change in middle cerebral artery velocity in response to carbon dioxide
Cerebrovascular Autoregulation
The change in phase delay measured by transfer function analysis
Full Information
NCT ID
NCT02875522
First Posted
August 4, 2016
Last Updated
August 17, 2016
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02875522
Brief Title
The Effects of Aerobic Exercise Training on Vascular, Cardiac and Cerebral Vascular Function in COPD
Official Title
The Effects of Aerobic Exercise Training on Peripheral Vascular, Cardiac and Cerebral Vascular Function in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Exercise Training, Flow-Mediated Dilation, Arterial Stiffness, Echocardiography, Cerebrovascular Physiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with COPD
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Individualized, non-linear aerobic exercise training
Intervention Description
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
Primary Outcome Measure Information:
Title
Endothelial Function
Description
The change in brachial artery flow mediated dilation measured using reactive hyperaemia
Time Frame
8-weeks (following 24 sessions of exercise training)
Secondary Outcome Measure Information:
Title
Arterial Stiffness
Description
The change in pulse wave velocity measured using tonometry
Time Frame
8-weeks (following 24 sessions of exercise training)
Title
Carotid intima-medial thickness
Description
The change in carotid intima-medial thickness measured by ultrasound
Time Frame
8-weeks (following 24 sessions of exercise training)
Title
Carotid Compliance
Description
The change in carotid compliance measured using tonometry and ultrasound for the carotid arteries
Time Frame
8-weeks (following 24 sessions of exercise training)
Title
Inflammatory Biomarkers
Description
The change in serum levels of CRP, IL-6, IL-10 and TNF-alpha measured using Luminex multiplex bead-based technology
Time Frame
8-weeks (following 24 sessions of exercise training)
Title
Systolic function
Description
The change in stroke volume using echocardiography
Time Frame
8-weeks (following 24 sessions of exercise training)
Title
Diastolic function
Description
The change in left ventricular end-diastolic volume using echocardiography
Time Frame
8-weeks (following 24 sessions of exercise training)
Title
Cerebral Blood Flow
Description
The change in cerebral and neck blood flow using ultrasound
Time Frame
8-weeks (following 24 sessions of exercise training)
Title
Cerebrovascular Reactivity
Description
The change in middle cerebral artery velocity in response to carbon dioxide
Time Frame
8-weeks (following 24 sessions of exercise training)
Title
Cerebrovascular Autoregulation
Description
The change in phase delay measured by transfer function analysis
Time Frame
8-weeks (following 24 sessions of exercise training)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Eves, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
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The Effects of Aerobic Exercise Training on Vascular, Cardiac and Cerebral Vascular Function in COPD
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