Helium-Hyperoxia and 6MWT Distance in COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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6-Minute Walk Test COPD Helium-Hyperoxia Exercise Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Oxygen

Intervention Type DRUG

Helium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Exertional dyspnea
* Activity limitation
* COPD

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Darcy D Marciniuk, MD, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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Edmonton General Hospital, Caritas Lung HEalth Centre

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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BIO-REB 05-186

Identifier Type: -

Identifier Source: org_study_id