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

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Roger Goldstein, West Park Healthcare Centre
ClinicalTrials.gov Identifier:
NCT01283685
First received: July 6, 2010
Last updated: July 10, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by West Park Healthcare Centre:

Primary Outcome Measures:
  • tolerable duration of symptom-limited high-intensity exercise [ Time Frame: 1 week ] [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01283685

Locations
Canada, Ontario
West Park Healthcare Centre
Toronto, Ontario, Canada, M6M 2J5
Sponsors and Collaborators
West Park Healthcare Centre
The Physicians' Services Incorporated Foundation
Investigators
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:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014