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Completed

NCT Number: NCT02300064

Exercise in Health and Chronic Obstructive Pulmonary Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Affairs Salt Lake City Heath Care System

Salt Lake City, Utah, 84148, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

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

Treatment and study plan

Knee-extensor exercise test

Other

Steady-state, single leg knee-extensor exercise at 20 Watts for 10 minutes

Exercise test with restricting/releasing blood flow

Other

10 minute submaximal (20 Watts) single leg knee-extensor exercise with blood flow clamped 10-15% lower by arterial infustion of phenylephrine; 10 minute passive single leg knee-extensor exercise with blood flow matched to the 20 Watt work rate level by arterial adenosine infusion; 10 minute seated rest with blood flow matched to the 20 Watt work rate level by adenosine infusion. Each test separated by at least 30 minutes rest.

Exercise test with variable oxygen concentration and MRI

Other

Two bouts of single leg knee-extensor exercise to maximal effort breathing regular air (21% oxygen) or 100% oxygen through a mouthpiece, with a 90 minute rest period between each bout. The same experiment performed again on a separate day in an magnetic resonance imaging (MRI) machine

Exercise test with oral antioxidant or placebo cocktail

Other

Antioxidants (Vitamin E - 400 international units, Vitamin C - 1000 milligrams and Alpha lipoic acid - 600 milligrams) or matching placebo capsules administered orally followed by femoral nerve stimulation and single leg knee-extensor exercise for 30 minutes at 50% maximum effort

Primary outcomes

  1. Change in Free Radical Concentration in Muscle Tissue Following Exercise

    Time frame: Baseline to two hours

Secondary outcomes

  1. Change in Free Radical Concentration in Muscle Venous Outflow following Exercise

    Time frame: Baseline to two hours

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Mechanisms of Adaptation to Exercise in Health and Chronic Obstructive Pulmonary Disease (COPD); Oxidative Stress Links Aging, Activity and Mobility

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2014
Registry last updated
Jun 1, 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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