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The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD

This study has been completed.
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00406705
First received: November 29, 2006
Last updated: May 3, 2007
Last verified: March 2007
  Purpose

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).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
COPD
Emphysema
Lung Diseases
Bronchitis, Chronic
Behavioral: Helium-Hyperoxia
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

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

Estimated Enrollment: 38
Study Start Date: March 2005
Study Completion Date: January 2007
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406705

Locations
Canada, Alberta
Caritas Centre for Lung Health
Edmonton, Alberta, Canada, T5K 0L4
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Neil D Eves, PhD University of Calgary, AB, Canada
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00406705     History of Changes
Other Study ID Numbers: MSI 824
Study First Received: November 29, 2006
Last Updated: May 3, 2007
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Exercise Tolerance
Dyspnea
Rehabilitation
Helium

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 25, 2014