The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD

Sponsor

University of Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT00406705

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine whether breathing helium-hyperoxia during exercise in a pulmonary rehabilitation program can improve the exercise tolerance and health related quality of life of patients with Chronic Obstructive Pulmonary Disease (COPD).

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease COPD Emphysema Lung Diseases Bronchitis, Chronic	Behavioral: Helium-Hyperoxia	Phase 2

Detailed Description

It is well accepted that the exercise training as part of a comprehensive pulmonary rehabilitation program can improve exercise tolerance, functional status and quality of life in patients with COPD. It is feasible that if patients were able to perform a greater volume or intensity of exercise during rehabilitation then the outcomes of the program would be improved. Recent research has demonstrated that breathing a helium-hyperoxic gas mixture can significantly reduce dynamic hyperinflation and dyspnea during exercise in patients with COPD and can increase exercise tolerance to a greater extent than breathing room air or a nitrogen-based hyperoxic gas. If patients with COPD were to breathe a helium-hyperoxic gas during exercise they should be able to tolerate a greater intensity of exercise while maintaining similar levels of exertional symptoms to those observed at lower exercise intensities breathing room air. As a result patients randomized to the helium-hyperoxia condition should obtain greater improvements in exercise tolerance than those receiving usual care (i.e. breathing room air)

Comparisons: Standard pulmonary rehabilitation of patients with COPD receiving either usual care (air breathing) or helium-hyperoxia (40% O2, 60% Helium).

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Trial to Study the Effect of Exercise Training Breathing Helium-Hyperoxia on The Exercise Tolerance and Quality of Life of Patients With Chronic Obstructive Pulmonary Disease

Study Start Date :

Mar 1, 2005

Actual Study Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

Constant-load exercise tolerance after 6 weeks of exercise rehabilitation []

Secondary Outcome Measures

Maximum oxygen consumption after 6 weeks of exercise rehabilitation []
Quality of Life measured after 6 weeks of exercise rehabilitation []
Dyspnea at an isotime during constant-load exercise after 6 weeks of exercise rehabilitation []