Helium-Hyperoxia and 6MWT Distance in COPD - Full Text View

Purpose

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	Intervention
Chronic Obstructive Pulmonary Disease	Drug: Oxygen Drug: Helium

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study

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

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:

6 minute walking distance

Secondary Outcome Measures:

shortness of breath
leg fatigue
arterial oxygen saturation

Estimated Enrollment:	16
Study Start Date:	July 2005
Estimated Study Completion Date:	May 2006

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Exertional dyspnea
Activity limitation
COPD

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394225

Locations


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

Sponsors and Collaborators

University of Saskatchewan

Capital District Health Authority, Canada

Investigators


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

More Information

Study ID Numbers:	BIO-REB 05-186
First Received:	October 30, 2006
Last Updated:	October 30, 2006
ClinicalTrials.gov Identifier:	NCT00394225
Health Authority:	Canada: Health Canada

Keywords provided by University of Saskatchewan:

6-Minute Walk Test

COPD

Helium-Hyperoxia

Exercise

Chronic Obstructive Pulmonary Disease (COPD)

Study placed in the following topic categories:

Hyperoxia

Signs and Symptoms

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Signs and Symptoms, Respiratory

Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 23, 2008

Sponsors and Collaborators:	University of Saskatchewan Capital District Health Authority, Canada
Information provided by:	University of Saskatchewan
ClinicalTrials.gov Identifier:	NCT00394225