Back to resultsThe Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease, COPD, Emphysema
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Helium-Hyperoxia
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Exercise Tolerance, Dyspnea, Rehabilitation, Helium
Eligibility Criteria
Inclusion Criteria:
- FEV1/FVC<70% predicted;
- FEV1<70% predicted;
- RV>140% predicted.
Exclusion Criteria:
- Cardiovascular contraindications to exercise;
- Musculoskeletal abnormalities that limit exercise tolerance;
- SpO2<85% during a constant work rate test;
- On supplemental oxygen.
- Exacerbation within the last month
Sites / Locations
- Caritas Centre for Lung Health
Outcomes
Primary Outcome Measures
Constant-load exercise tolerance after 6 weeks of exercise rehabilitation
Secondary Outcome Measures
Maximum oxygen consumption after 6 weeks of exercise rehabilitation
Quality of Life measured after 6 weeks of exercise rehabilitation
Dyspnea at an isotime during constant-load exercise after 6 weeks of exercise rehabilitation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00406705
Brief Title
The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD
Official Title
A Randomized Controlled Trial to Study the Effect of Exercise Training Breathing Helium-Hyperoxia on The Exercise Tolerance and Quality of Life of Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Alberta
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to examine whether breathing helium-hyperoxia during exercise in a pulmonary rehabilitation program can improve the exercise tolerance and health related quality of life of patients with Chronic Obstructive Pulmonary Disease (COPD).
Detailed Description
It is well accepted that the exercise training as part of a comprehensive pulmonary rehabilitation program can improve exercise tolerance, functional status and quality of life in patients with COPD. It is feasible that if patients were able to perform a greater volume or intensity of exercise during rehabilitation then the outcomes of the program would be improved. Recent research has demonstrated that breathing a helium-hyperoxic gas mixture can significantly reduce dynamic hyperinflation and dyspnea during exercise in patients with COPD and can increase exercise tolerance to a greater extent than breathing room air or a nitrogen-based hyperoxic gas. If patients with COPD were to breathe a helium-hyperoxic gas during exercise they should be able to tolerate a greater intensity of exercise while maintaining similar levels of exertional symptoms to those observed at lower exercise intensities breathing room air. As a result patients randomized to the helium-hyperoxia condition should obtain greater improvements in exercise tolerance than those receiving usual care (i.e. breathing room air)
Comparisons: Standard pulmonary rehabilitation of patients with COPD receiving either usual care (air breathing) or helium-hyperoxia (40% O2, 60% Helium).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD, Emphysema, Lung Diseases, Bronchitis, Chronic
Keywords
Exercise Tolerance, Dyspnea, Rehabilitation, Helium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
38 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Helium-Hyperoxia
Primary Outcome Measure Information:
Title
Constant-load exercise tolerance after 6 weeks of exercise rehabilitation
Secondary Outcome Measure Information:
Title
Maximum oxygen consumption after 6 weeks of exercise rehabilitation
Title
Quality of Life measured after 6 weeks of exercise rehabilitation
Title
Dyspnea at an isotime during constant-load exercise after 6 weeks of exercise rehabilitation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
FEV1/FVC<70% predicted;
FEV1<70% predicted;
RV>140% predicted.
Exclusion Criteria:
Cardiovascular contraindications to exercise;
Musculoskeletal abnormalities that limit exercise tolerance;
SpO2<85% during a constant work rate test;
On supplemental oxygen.
Exacerbation within the last month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil D Eves, PhD
Organizational Affiliation
University of Calgary, AB, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caritas Centre for Lung Health
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 0L4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
16840742
Citation
Eves ND, Petersen SR, Haykowsky MJ, Wong EY, Jones RL. Helium-hyperoxia, exercise, and respiratory mechanics in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2006 Oct 1;174(7):763-71. doi: 10.1164/rccm.200509-1533OC. Epub 2006 Jul 13.
Results Reference
background
PubMed Identifier
19017883
Citation
Eves ND, Sandmeyer LC, Wong EY, Jones LW, MacDonald GF, Ford GT, Petersen SR, Bibeau MD, Jones RL. Helium-hyperoxia: a novel intervention to improve the benefits of pulmonary rehabilitation for patients with COPD. Chest. 2009 Mar;135(3):609-618. doi: 10.1378/chest.08-1517. Epub 2008 Nov 18.
Results Reference
derived
Learn more about this trial
The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD
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