Breathing Helium-Hyperoxia During Exercise in Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
breathing helium-hyperoxia
breathing supplemental oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Exercise, Physical
Eligibility Criteria
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
Sites / Locations
- West Park Healthcare Centre
Outcomes
Primary Outcome Measures
tolerable duration of symptom-limited high-intensity exercise
Secondary Outcome Measures
heart rate
oxygen saturation
Breathlessness
leg fatigue
Full Information
NCT ID
NCT01283685
First Posted
July 6, 2010
Last Updated
July 10, 2012
Sponsor
West Park Healthcare Centre
Collaborators
The Physicians' Services Incorporated Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01283685
Brief Title
Breathing Helium-Hyperoxia During Exercise in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Does Breathing Helium-Hyperoxia Increase the Tolerance of One-Legged Exercise in Ventilatory Limited Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Park Healthcare Centre
Collaborators
The Physicians' Services Incorporated Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Exercise, Physical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
breathing helium-hyperoxia
Intervention Description
40% O2, 60% He
Intervention Type
Other
Intervention Name(s)
breathing supplemental oxygen
Intervention Description
oxygen (4 L/min) provided by nasal cannula
Primary Outcome Measure Information:
Title
tolerable duration of symptom-limited high-intensity exercise
Time Frame
1 week
Secondary Outcome Measure Information:
Title
heart rate
Time Frame
1 week
Title
oxygen saturation
Time Frame
1 week
Title
Breathlessness
Time Frame
1 week
Title
leg fatigue
Time Frame
1 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger S Goldstein, MD
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Park Healthcare Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 2J5
Country
Canada
12. IPD Sharing Statement
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Breathing Helium-Hyperoxia During Exercise in Patients With Chronic Obstructive Pulmonary Disease
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