Helium-Hyperoxia and 6MWT Distance in COPD

October 30, 2006 updated by: University of Saskatchewan

The Effects of Helium-Hyperoxia on 6-Minute Walking Distance in Chronic Obstructive Pulmonary Disease - A Randomized, Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Edmonton General Hospital, Caritas Lung HEalth Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Exertional dyspnea
  • Activity limitation
  • COPD

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
6 minute walking distance

Secondary Outcome Measures

Outcome Measure
shortness of breath
leg fatigue
arterial oxygen saturation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Darcy D Marciniuk, MD, FRCP(C), University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

October 30, 2006

First Submitted That Met QC Criteria

October 30, 2006

First Posted (ESTIMATE)

October 31, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2006

Last Update Submitted That Met QC Criteria

October 30, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-REB 05-186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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