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

Study Overview
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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).

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Helium-Hyperoxia


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Helium-Hyperoxia|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-load exercise tolerance after 6 weeks of exercise rehabilitation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyspnea, Exercise Tolerance, Rehabilitation, Helium