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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00406705
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : May 4, 2007
Information provided by:
University of Alberta

Brief 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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease COPD Emphysema Lung Diseases Bronchitis, Chronic Behavioral: Helium-Hyperoxia Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : March 2005
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Constant-load exercise tolerance after 6 weeks of exercise rehabilitation

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00406705

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Canada, Alberta
Caritas Centre for Lung Health
Edmonton, Alberta, Canada, T5K 0L4
Sponsors and Collaborators
University of Alberta
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Principal Investigator: Neil D Eves, PhD University of Calgary, AB, Canada

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00406705    
Other Study ID Numbers: MSI 824
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: May 4, 2007
Last Verified: March 2007
Keywords provided by University of Alberta:
Exercise Tolerance
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchitis, Chronic
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms