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Completed

NCT Number: NCT00394225

Helium-Hyperoxia and 6MWT Distance in COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edmonton General Hospital, Caritas Lung HEalth Centre

Edmonton, Alberta, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Exertional dyspnea
  • Activity limitation
  • COPD

Exclusion criteria

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

Treatment and study plan

Oxygen

Drug

Helium

Drug

Primary outcomes

  1. 6 minute walking distance

Secondary outcomes

  1. shortness of breath

  2. leg fatigue

  3. arterial oxygen saturation

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Nova Scotia Health Authority

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Oct 31, 2006
Registry last updated
Oct 31, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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