Exercise in Health and Chronic Obstructive Pulmonary Disease

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Knee-extensor exercise test; Other: Exercise test with restricting/releasing blood flow; Other: Exercise test with variable oxygen concentration and MRI; Other: Exercise test with oral antioxidant or placebo cocktail

• Registration Number: NCT02300064
• Lead Sponsor: University of Utah

Brief Summary

The purpose of this study is to find out more about the effects of chronic obstructive pulmonary disease (COPD) on the function of blood vessels, the heart, and muscle at rest and during exercise.

Detailed Description

Oxidative stress, defined as an imbalance between pro and antioxidant molecular species in favor of the former, has recently been recognized as a potential mechanism in the peripheral muscle dysfunction associated with COPD. a series of studies are proposed to better understand the role and source of oxidative stress in the skeletal muscle of patients with COPD. Specifically, three main aims will address the following questions regarding COPD, skeletal muscle, and oxidative stress: where is oxidative stress most prevalent, why does oxidative stress occur, and what are the consequences of oxidative stress in COPD? the overall hypothesis to be tested is that COPD results in a shift toward greater intramuscular oxidative stress and this is, at least in part, responsible for the diminished mechanical efficiency and greater peripheral muscle fatiguability during muscular work often associated with this disease. The vascular consequence of this augmented free radical load is altered vascular function and a disruption of the local matching of perfusion and metabolism in skeletal muscle during exercise. These crucial changes result in a cascade of factors such as local hypoxia and elevated vascular shear stress, entering a vicious cycle that leads to the generation of more free radicals, especially during physical work. It is proposed that this imbalance between pro and antioxidant potential, toward oxidative stress, plays a significant role in the attenuated exercise capacity and reduced muscle fatigue resistance associated with COPD.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-28
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• Chronic Obstructive Pulmonary Disease (COPD) patients (over 18 years old) and
• age-matched healthy controls (over 18 years old)

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Exclusion Criteria

• Severe Chronic Obstructive Pulmonary Disease (volume exhaled at the end of the first section of forced expiration is predicted to be under 30 percent),
• Severe Heart Failure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Exercise test with variable oxygen concentration and MRI	Healthy volunteers will undergo one or more exercise interventions: knee-extensor exercise test; exercise test with restricting/releasing blood flow; exercise test with variable oxygen concentration and MRI; or exercise test with oral antioxidant or placebo cocktail.
Healthy volunteers	Knee-extensor exercise test	Healthy volunteers will undergo one or more exercise interventions: knee-extensor exercise test; exercise test with restricting/releasing blood flow; exercise test with variable oxygen concentration and MRI; or exercise test with oral antioxidant or placebo cocktail.
Healthy volunteers	Exercise test with oral antioxidant or placebo cocktail	Healthy volunteers will undergo one or more exercise interventions: knee-extensor exercise test; exercise test with restricting/releasing blood flow; exercise test with variable oxygen concentration and MRI; or exercise test with oral antioxidant or placebo cocktail.
COPD patients	Knee-extensor exercise test	Patients with Chronic Obstructive Pulmonary Disease (COPD) will undergo one or more exercise interventions: knee-extensor exercise test; exercise test with restricting/releasing blood flow; exercise test with variable oxygen concentration and MRI; or exercise test with oral antioxidant or placebo cocktail.
COPD patients	Exercise test with variable oxygen concentration and MRI	Patients with Chronic Obstructive Pulmonary Disease (COPD) will undergo one or more exercise interventions: knee-extensor exercise test; exercise test with restricting/releasing blood flow; exercise test with variable oxygen concentration and MRI; or exercise test with oral antioxidant or placebo cocktail.
COPD patients	Exercise test with oral antioxidant or placebo cocktail	Patients with Chronic Obstructive Pulmonary Disease (COPD) will undergo one or more exercise interventions: knee-extensor exercise test; exercise test with restricting/releasing blood flow; exercise test with variable oxygen concentration and MRI; or exercise test with oral antioxidant or placebo cocktail.
COPD patients	Exercise test with restricting/releasing blood flow	Patients with Chronic Obstructive Pulmonary Disease (COPD) will undergo one or more exercise interventions: knee-extensor exercise test; exercise test with restricting/releasing blood flow; exercise test with variable oxygen concentration and MRI; or exercise test with oral antioxidant or placebo cocktail.
Healthy volunteers	Exercise test with restricting/releasing blood flow	Healthy volunteers will undergo one or more exercise interventions: knee-extensor exercise test; exercise test with restricting/releasing blood flow; exercise test with variable oxygen concentration and MRI; or exercise test with oral antioxidant or placebo cocktail.

Primary Outcome Measures

Name	Time	Method
Change in Free Radical Concentration in Muscle Tissue Following Exercise	Baseline to two hours

Secondary Outcome Measures

Name	Time	Method
Change in Free Radical Concentration in Muscle Venous Outflow following Exercise	Baseline to two hours

Trial Locations

Locations (1)

Veterans Affairs Salt Lake City Heath Care System; 🇺🇸 Salt Lake City, Utah, United States