Chronic Obstructive Pulmonary DiseasePhase 2NCT00406705
The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD
A Phase 2 study testing Helium-Hyperoxia in people with Chronic Obstructive Pulmonary Disease and COPD, run by University of Alberta at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD, Emphysema
- What is being tested?
- Helium-Hyperoxia
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2005to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- FEV1/FVC<70% predicted;
- FEV1<70% predicted;
- RV>140% predicted.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD, Emphysema, Lung Diseases, Bronchitis, Chronic
- Being tested
- Helium-Hyperoxia
- Keywords
- Exercise Tolerance, Dyspnea, Rehabilitation, Helium
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Lung Diseases, Bronchitis, Chronic, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helium-HyperoxiaBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-load exercise tolerance after 6 weeks of exercise rehabilitation
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startMar 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 38 participants
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Neil D Eves, PhD, Principal investigator, University of Calgary, AB, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406705
- Sponsor's protocol ID
- MSI 824
- Status last verified
- Mar 2007
- First submitted
- 29 Nov 2006
- Last updated
- 4 May 2007
- Results posted
- No
Publications
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.
PubMed 16840742Eves 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.
PubMed 19017883
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00406705
- Acronym / sponsor ID
- MSI 824
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD, Emphysema, Lung Diseases, Bronchitis, Chronic
- Keywords
- Exercise Tolerance, Dyspnea, Rehabilitation, Helium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- FEV1/FVC<70% predicted;
- FEV1<70% predicted;
- RV>140% predicted.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helium-Hyperoxia | Behavioural | – |
Primary outcome
Constant-load exercise tolerance after 6 weeks of exercise rehabilitation
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2007.
- Background: PubMed 16840742Eves 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.
- Derived from this study: PubMed 19017883Eves 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil D Eves, PhD principal investigator
University of Calgary, AB, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Helium-Hyperoxia in people with Chronic Obstructive Pulmonary Disease and COPD, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-load exercise tolerance after 6 weeks of exercise rehabilitation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00406705, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2007.