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Breathing Helium-Hyperoxia During Exercise in Patients With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT01283685
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : July 11, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Other: breathing helium-hyperoxia Other: breathing supplemental oxygen

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Other: breathing helium-hyperoxia
    40% O2, 60% He
    Other: breathing supplemental oxygen
    oxygen (4 L/min) provided by nasal cannula

Outcome Measures

Primary Outcome Measures :
  1. tolerable duration of symptom-limited high-intensity exercise [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. heart rate [ Time Frame: 1 week ]
  2. oxygen saturation [ Time Frame: 1 week ]
  3. Breathlessness [ Time Frame: 1 week ]
  4. leg fatigue [ Time Frame: 1 week ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT01283685

Canada, Ontario
West Park Healthcare Centre
Toronto, Ontario, Canada, M6M 2J5
Sponsors and Collaborators
West Park Healthcare Centre
The Physicians' Services Incorporated Foundation
Principal Investigator: Roger S Goldstein, MD West Park Healthcare Centre
More Information

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
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012

Keywords provided by Roger Goldstein, West Park Healthcare Centre:
Exercise, Physical

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms