Helium-Hyperoxia and 6MWT Distance in COPD

• Sponsor: University of Saskatchewan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00394225
• Collaborator: Nova Scotia Health Authority (Other)
• Enrollment: 16
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jul 1, 2005
• Study Completion Date: May 1, 2006

Outcome Measures

Primary Outcome Measures

1. 6 minute walking distance []

Secondary Outcome Measures

1. shortness of breath []

2. leg fatigue []

3. arterial oxygen saturation []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edmonton General Hospital, Caritas Lung HEalth Centre	Edmonton	Alberta	Canada

Sponsors and Collaborators

• University of Saskatchewan
• Nova Scotia Health Authority

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00394225
• Other Study ID Numbers: BIO-REB 05-186
• First Posted: Oct 31, 2006
• Last Update Posted: Oct 31, 2006
• Last Verified: Oct 1, 2006

• Keywords provided by , ,: 6-Minute Walk Test; COPD; Helium-Hyperoxia; Exercise; Chronic Obstructive Pulmonary Disease (COPD)
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hyperoxia

Study Results

No Results Posted as of Oct 31, 2006