The Effects of Aerobic Exercise Training on Vascular, Cardiac and Cerebral Vascular Function in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Effects of Aerobic Exercise Training on Peripheral Vascular, Cardiac and Cerebral Vascular Function in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875522
• Other study ID #: H11-02770
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: August 17, 2016
• Start date: January 2012
• Est. completion date: May 2015

Study information

• Verified date: August 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Individualized, non-linear aerobic exercise training
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

Locations

Country	Name	City	State
Canada	University of British Columbia	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function	The change in brachial artery flow mediated dilation measured using reactive hyperaemia	8-weeks (following 24 sessions of exercise training)	No
Secondary	Arterial Stiffness	The change in pulse wave velocity measured using tonometry	8-weeks (following 24 sessions of exercise training)	No
Secondary	Carotid intima-medial thickness	The change in carotid intima-medial thickness measured by ultrasound	8-weeks (following 24 sessions of exercise training)	No
Secondary	Carotid Compliance	The change in carotid compliance measured using tonometry and ultrasound for the carotid arteries	8-weeks (following 24 sessions of exercise training)	No
Secondary	Inflammatory Biomarkers	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)	No
Secondary	Systolic function	The change in stroke volume using echocardiography	8-weeks (following 24 sessions of exercise training)	No
Secondary	Diastolic function	The change in left ventricular end-diastolic volume using echocardiography	8-weeks (following 24 sessions of exercise training)	No
Secondary	Cerebral Blood Flow	The change in cerebral and neck blood flow using ultrasound	8-weeks (following 24 sessions of exercise training)	No
Secondary	Cerebrovascular Reactivity	The change in middle cerebral artery velocity in response to carbon dioxide	8-weeks (following 24 sessions of exercise training)	No
Secondary	Cerebrovascular Autoregulation	The change in phase delay measured by transfer function analysis	8-weeks (following 24 sessions of exercise training)	No