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

NCT01283685 | Completed

• 1 other identifier: PSI-10q2109
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Exercise, Physical

Outcome Measures

Primary Outcomes (1)

• tolerable duration of symptom-limited high-intensity exercise

  1 week

Secondary Outcomes (4)

• heart rate

  1 week

• oxygen saturation

  1 week

• Breathlessness

  1 week

• leg fatigue

  1 week

Interventions

breathing helium-hyperoxia OTHER

40% O2, 60% He

breathing supplemental oxygen OTHER

oxygen (4 L/min) provided by nasal cannula

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of COPD
• Cardiopulmonary impairment
• Ventilatory limitation

You may not qualify if:

• 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

Sponsors & Collaborators

• West Park Healthcare Centre: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Roger S Goldstein, MD

  West Park Healthcare Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Program in Respiratory Rehabilitation

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: January 26, 2011
• Study Start: July 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

CA (1)