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Helium-Hyperoxia and 6MWT Distance in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394225
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : October 31, 2006
Nova Scotia Health Authority
Information provided by:
University of Saskatchewan

Brief Summary:
We assessed the effect of altering inspired gas on the 6MWT distance in COPD. We hypothesized that HeO2 would improve walking distance and reduce shortness of breath compared to both RA and O2, and potentially improve quality of life for COPD patients.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Oxygen Drug: Helium Not Applicable

Detailed Description:

We hypothesized that inspiring helium-hyperoxia (HeO2) would significantly improve 6-minute walking test (6MWT) distance in Chronic Obstructive Pulmonary Disease (COPD) subjects.

This was a blinded, randomized crossover study. At Visit 1 we assessed pulmonary function, exercise capacity and 6MWT distance. Visits 2 and 3 consisted of four 6MWT with different inspired gases: room air by mask (RA), 100% O2 by mask (Mask O2), 100% O2 by nasal prongs (Nasal O2), and 70% He/30% O2 by mask (HeO2). Walking distance, shortness of breath, leg fatigue, O2 saturation and heart rate (HR) were assessed

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Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effects of Helium-Hyperoxia on 6-Minute Walking Distance in Chronic Obstructive Pulmonary Disease – A Randomized, Controlled Trial
Study Start Date : July 2005
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Primary Outcome Measures :
  1. 6 minute walking distance

Secondary Outcome Measures :
  1. shortness of breath
  2. leg fatigue
  3. arterial oxygen saturation

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Exertional dyspnea
  • Activity limitation
  • COPD

Exclusion Criteria:

  • Recent exacerbation (< 4 wks)
  • Supplemental O2
  • Significant cardiovascular/musculoskeletal abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00394225

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Canada, Alberta
Edmonton General Hospital, Caritas Lung HEalth Centre
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Saskatchewan
Nova Scotia Health Authority
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Principal Investigator: Darcy D Marciniuk, MD, FRCP(C) University of Saskatchewan

Layout table for additonal information Identifier: NCT00394225     History of Changes
Other Study ID Numbers: BIO-REB 05-186
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: October 31, 2006
Last Verified: October 2006
Keywords provided by University of Saskatchewan:
6-Minute Walk Test
Chronic Obstructive Pulmonary Disease (COPD)
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms