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

NCT ID: NCT00406705

Last Updated: 2007-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-01-31

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Chronic Obstructive Pulmonary Disease COPD Emphysema Lung Diseases Bronchitis, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Helium-Hyperoxia

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Principal Investigators

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Neil D Eves, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary, AB, Canada

Locations

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Caritas Centre for Lung Health

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 16840742 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19017883 (View on PubMed)

Other Identifiers

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MSI 824

Identifier Type: -

Identifier Source: org_study_id