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Completed

NCT Number: NCT00406705

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

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).

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • FEV1/FVC<70% predicted;
  • FEV1<70% predicted;
  • RV>140% predicted.

Exclusion criteria

  • Cardiovascular contraindications to exercise;
  • Musculoskeletal abnormalities that limit exercise tolerance;
  • SpO2<85% during a constant work rate test;
  • On supplemental oxygen.
  • Exacerbation within the last month

Treatment and study plan

Helium-Hyperoxia

Behavioral

Primary outcomes

  1. Constant-load exercise tolerance after 6 weeks of exercise rehabilitation

Secondary outcomes

  1. Maximum oxygen consumption after 6 weeks of exercise rehabilitation

  2. Quality of Life measured after 6 weeks of exercise rehabilitation

  3. Dyspnea at an isotime during constant-load exercise after 6 weeks of exercise rehabilitation

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2007
First posted
Dec 4, 2006
Registry last updated
May 4, 2007

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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