Exercise in Health and Chronic Obstructive Pulmonary Disease

NCT02300064 | Completed DMC

• 1 other identifier: 32404
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change in Free Radical Concentration in Muscle Tissue Following Exercise

  Baseline to two hours

Secondary Outcomes (1)

• Change in Free Radical Concentration in Muscle Venous Outflow following Exercise

  Baseline to two hours

Study Arms (2)

Healthy volunteers

EXPERIMENTAL

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.

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

COPD patients

EXPERIMENTAL

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.

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

Interventions

Knee-extensor exercise test OTHER

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

COPD patients; Healthy volunteers

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.

COPD patients; Healthy volunteers

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

COPD patients; Healthy volunteers

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

COPD patients; Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Veterans Affairs Salt Lake City Heath Care System

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise Test; Magnetic Resonance Spectroscopy; Antioxidants

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Officials

• Russell Richardson, Ph.D.

  US Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 24, 2014
• Study Start: January 1, 2009
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

US (1)