The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease COPD Emphysema Lung Diseases Bronchitis, Chronic |
Behavioral: Helium-Hyperoxia |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
- Constant-load exercise tolerance after 6 weeks of exercise rehabilitation
- 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
| Estimated Enrollment: | 38 |
| Study Start Date: | March 2005 |
| Study Completion Date: | January 2007 |
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).
Eligibility| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Canada, Alberta | |
| Caritas Centre for Lung Health | |
| Edmonton, Alberta, Canada, T5K 0L4 | |
| Principal Investigator: | Neil D Eves, PhD | University of Calgary, AB, Canada |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00406705 History of Changes |
| Other Study ID Numbers: | MSI 824 |
| Study First Received: | November 29, 2006 |
| Last Updated: | May 3, 2007 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Alberta:
|
Exercise Tolerance Dyspnea Rehabilitation Helium |
Additional relevant MeSH terms:
|
Bronchitis Bronchitis, Chronic Emphysema Pulmonary Emphysema Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Hyperoxia |
Lung Diseases, Obstructive Bronchial Diseases Respiratory Tract Diseases Respiratory Tract Infections Pathologic Processes Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013