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CompletedNCT00406705Updated May 4, 2007

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

A Phase 2 interventional study of Helium-Hyperoxia in Chronic Obstructive Pulmonary Disease, COPD and Emphysema, sponsored by University of Alberta. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2007-05-04.

Sponsored by University of Alberta · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
38
Allocation
Randomized
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • COPD
  • Emphysema
  • Lung Diseases
  • Bronchitis, Chronic

Keywords

  • Exercise Tolerance
  • Dyspnea
  • Rehabilitation
  • Helium
03

In context

Bronchitis

268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.

This study's enrollment of 38 is below the median of 120 across 184 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
38 participants

Interventions

  • BehavioralHelium-Hyperoxia
06

What researchers measure

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

07

Study locations

1 site
  • Caritas Centre for Lung Health
    Edmonton, Alberta T5K 0L4, Canada
08

References and documents

Publications

  • Eves ND, Petersen SR, Haykowsky MJ, Wong EY, Jones RL. Helium-hyperoxia, exercise, and respiratory mechanics in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2006 Oct 1;174(7):763-71. doi: 10.1164/rccm.200509-1533OC. Epub 2006 Jul 13. PubMed 16840742 ↗
  • Eves ND, Sandmeyer LC, Wong EY, Jones LW, MacDonald GF, Ford GT, Petersen SR, Bibeau MD, Jones RL. Helium-hyperoxia: a novel intervention to improve the benefits of pulmonary rehabilitation for patients with COPD. Chest. 2009 Mar;135(3):609-618. doi: 10.1378/chest.08-1517. Epub 2008 Nov 18. PubMed 19017883 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00406705
Lead sponsor
University of Alberta
First posted
Dec 4, 2006
Start date
Mar 2005
Completion
Jan 2007
Last update
May 4, 2007

Study contacts

Neil D Eves, PhD
principal investigator · University of Calgary, AB, Canada
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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