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Helium-Hyperoxia and 6MWT Distance in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oxygen
Helium
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring 6-Minute Walk Test, COPD, Helium-Hyperoxia, Exercise, Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Exertional dyspnea
  • Activity limitation
  • COPD

Exclusion Criteria:

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

Sites / Locations

  • Edmonton General Hospital, Caritas Lung HEalth Centre

Outcomes

Primary Outcome Measures

6 minute walking distance

Secondary Outcome Measures

shortness of breath
leg fatigue
arterial oxygen saturation

Full Information

First Posted
October 30, 2006
Last Updated
October 30, 2006
Sponsor
University of Saskatchewan
Collaborators
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT00394225
Brief Title
Helium-Hyperoxia and 6MWT Distance in COPD
Official Title
The Effects of Helium-Hyperoxia on 6-Minute Walking Distance in Chronic Obstructive Pulmonary Disease - A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Saskatchewan
Collaborators
Nova Scotia Health Authority

4. Oversight

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
6-Minute Walk Test, COPD, Helium-Hyperoxia, Exercise, Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
16 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Type
Drug
Intervention Name(s)
Helium
Primary Outcome Measure Information:
Title
6 minute walking distance
Secondary Outcome Measure Information:
Title
shortness of breath
Title
leg fatigue
Title
arterial oxygen saturation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Exertional dyspnea Activity limitation COPD Exclusion Criteria: Recent exacerbation (< 4 wks) Supplemental O2 Significant cardiovascular/musculoskeletal abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darcy D Marciniuk, MD, FRCP(C)
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edmonton General Hospital, Caritas Lung HEalth Centre
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

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Helium-Hyperoxia and 6MWT Distance in COPD

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