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

This study has been completed.
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00406705
First received: November 29, 2006
Last updated: May 3, 2007
Last verified: March 2007
History of Changes

November 29, 2006
May 3, 2007
March 2005
Not Provided
Constant-load exercise tolerance after 6 weeks of exercise rehabilitation
Same as current
Complete list of historical versions of study NCT00406705 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD
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

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).

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).
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Chronic Obstructive Pulmonary Disease
  • COPD
  • Emphysema
  • Lung Diseases
  • Bronchitis, Chronic
Behavioral: Helium-Hyperoxia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
January 2007
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00406705
MSI 824
Not Provided
Not Provided
University of Alberta
Not Provided
Principal Investigator: Neil D Eves, PhD University of Calgary, AB, Canada
University of Alberta
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP