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Completed

NCT Number: NCT02875522

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized, non-linear aerobic exercise training

Other

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 outcomes

  1. Endothelial Function

    Time frame: 8-weeks (following 24 sessions of exercise training)

    The change in brachial artery flow mediated dilation measured using reactive hyperaemia

Secondary outcomes

  1. Arterial Stiffness

    Time frame: 8-weeks (following 24 sessions of exercise training)

    The change in pulse wave velocity measured using tonometry

  2. Carotid intima-medial thickness

    Time frame: 8-weeks (following 24 sessions of exercise training)

    The change in carotid intima-medial thickness measured by ultrasound

  3. 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

  4. 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

  5. Systolic function

    Time frame: 8-weeks (following 24 sessions of exercise training)

    The change in stroke volume using echocardiography

  6. Diastolic function

    Time frame: 8-weeks (following 24 sessions of exercise training)

    The change in left ventricular end-diastolic volume using echocardiography

  7. Cerebral Blood Flow

    Time frame: 8-weeks (following 24 sessions of exercise training)

    The change in cerebral and neck blood flow using ultrasound

  8. Cerebrovascular Reactivity

    Time frame: 8-weeks (following 24 sessions of exercise training)

    The change in middle cerebral artery velocity in response to carbon dioxide

  9. Cerebrovascular Autoregulation

    Time frame: 8-weeks (following 24 sessions of exercise training)

    The change in phase delay measured by transfer function analysis

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 23, 2016
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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