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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406705
• Other study ID #: MSI 824
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2006
• Last updated: May 3, 2007
• Start date: March 2005
• Est. completion date: January 2007

Study information

• Verified date: March 2007
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Helium-Hyperoxia

Locations

Country	Name	City	State
Canada	Caritas Centre for Lung Health	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. Epub 2006 Jul 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant-load exercise tolerance after 6 weeks of exercise rehabilitation
Secondary	Maximum oxygen consumption after 6 weeks of exercise rehabilitation
Secondary	Quality of Life measured after 6 weeks of exercise rehabilitation
Secondary	Dyspnea at an isotime during constant-load exercise after 6 weeks of exercise rehabilitation