Breathing Helium-Hyperoxia During Exercise in Patients With Chronic Obstructive Pulmonary Disease
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Purpose
Regular exercise can help patients with the lung disease, chronic obstructive pulmonary disease (COPD). But COPD patients have a hard time with training because of their breathing. To improve their program they can train with one leg at a time. Another way is to make their exercise easier by breathing helium. Putting two methods, one-legged and helium, together may improve their program even more. This project is planned to assess whether breathing helium improves their one-legged exercise endurance. If it does, then there may be a reason for combining one-legged exercise with breathing helium as part of their respiratory rehabilitation program. The aim of this study is to determine whether breathing helium-hyperoxia enables a further increase in the constant power endurance time during one-legged exercise in ventilatory limited subjects with COPD. The null hypothesis is that patients will have sufficient peripheral muscle limitation that ventilatory unloading using helium-hyperoxia will be of no additional benefit to exercise tolerance. The investigators hypothesize that patients with COPD are so ventilatory limited relative to their peripheral muscles that helium-hyperoxia will improve their exercise endurance.
| Condition | Intervention |
|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Other: breathing helium-hyperoxia Other: breathing supplemental oxygen |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Does Breathing Helium-Hyperoxia Increase the Tolerance of One-Legged Exercise in Ventilatory Limited Patients With Chronic Obstructive Pulmonary Disease |
- tolerable duration of symptom-limited high-intensity exercise [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- heart rate [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- oxygen saturation [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Breathlessness [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- leg fatigue [ Time Frame: 1 week ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | July 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
-
Other: breathing helium-hyperoxia
This is a randomized cross-over comparison trial determining the effects of helium-hyperoxia on the performance of muscle specific one-legged cycling. Each participant will complete two constant power exercise tests while cycling with their right leg only. The tests will be separated by at least 24 h. The conditions of the two tests will be the same except that, in randomized order, the participant will breathe helium-hyperoxia (40% O2, 60% He) through a mask, or room air unencumbered by a mask with supplemental oxygen (4 L/min) provided by nasal cannula.
Participants will perform three exercise tests. First they will complete one incremental power exercise test using both legs (exercise capacity) in a standardized manner. Then they will complete two constant power (exercise endurance) cycle ergometer tests to the limit of tolerance (symptom based); the intent is to set an exercise level that comparable to the ideal training session that a patient would experience in the respiratory rehabilitation program. The same exercise regimen will be used in these two sessions except that the participant will breathe helium-hyperoxia (40% O2, 60% He) in one session and room air, with supplemental oxygen (4 L/min) provided by nasal cannula, in the other. During all exercise sessions, heart rate, SaO2, and Borg scale ratings of dyspnoea and leg fatigue will be monitored. For each exercise test, participants will adhere to their usual medical regimens, not eat for 2 h before the test and not drink caffeinated beverages for 2 h before the test. All tests will be separated by at least 24 h.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- clinical diagnosis of COPD
- Cardiopulmonary impairment
- Ventilatory limitation
Exclusion Criteria:
- inability to communicate in English
- cardiac rhythm or circulatory compromise
- recent myocardial infarct
- moderate-severe aortic stenosis
- uncontrolled hypertension
- sustained cardiac arrhythmias
- untreated neoplasia
- lung surgery within the previous three months
- any other predominant co-morbidities, such as chronic heart failure, or treatments that might influence the results of exercise testing
Contacts and Locations| Canada, Ontario | |
| West Park Healthcare Centre | |
| Toronto, Ontario, Canada, M6M 2J5 | |
| Principal Investigator: | Roger S Goldstein, MD | West Park Healthcare Centre |
More Information
No publications provided
| Responsible Party: | Roger Goldstein, Director, Program in Respiratory Rehabilitation, West Park Healthcare Centre |
| ClinicalTrials.gov Identifier: | NCT01283685 History of Changes |
| Other Study ID Numbers: | PSI-10q2109 |
| Study First Received: | July 6, 2010 |
| Last Updated: | July 10, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by West Park Healthcare Centre:
|
Exercise, Physical |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Hyperoxia Lung Diseases, Obstructive |
Disease Attributes Pathologic Processes Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013