Clinical trial NCT00406705: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Emphysema
Lung Diseases
Bronchitis, Chronic
Keywords: Exercise Tolerance
Dyspnea
Rehabilitation
Helium
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2006-12-04
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Constant-load exercise tolerance after 6 weeks of exercise rehabilitation
Secondary outcomes:
measure: Maximum oxygen consumption after 6 weeks of exercise rehabilitation
measure: Quality of Life measured after 6 weeks of exercise rehabilitation
measure: Dyspnea at an isotime during constant-load exercise after 6 weeks of exercise rehabilitation
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Caritas Centre for Lung Health
state: Alberta
Study officials:
affiliation: University of Calgary, AB, Canada
name: Neil D Eves, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.