Use of an Air Warming Mask for Exercise in Patients With COPD V1.0
Recruitment status was: Recruiting
The World Health Organisation defines chronic obstructive pulmonary disease (COPD) as 'not one single disease but an umbrella term used to describe chronic lung diseases that cause limitations in lung airflow' covering emphysema and chronic bronchitis; and estimates (2004) that worldwide there are currently 64 million sufferers with 3 to 4 million in the UK.
COPD results from damaged airways in the lungs, causing them to become narrower and making it harder for air to get in and out of the lungs. It is diagnosed by measuring the amount of air that can be expelled in the first second of breathing out (FEV1) in litres per second.
COPD is a progressive disease and the condition can have a serious impact on the quality of life of sufferers. Going out in very cold weather can cause an immediate drop in FEV1, and increased breathlessness.
This is a randomised crossover controlled trial of participants with COPD. It compares the effectiveness of an air-warming face mask which covers the mouth compared with no face covering, in increasing participants exercise capacity and quality of life in cold weather. The mask warms air at the mouth by drawing on air warmed beneath the participants clothing, through a 20cm long hollow plastic tube and a one-way inspiratory valve into the mask. Air is expired through the nose.
24 participants with moderate or severe COPD, will undertake 3 exercise tests on 3 separate days. Two tests will be in an environmentally controlled chamber performed at 5°C with participants wearing either the mask or no face covering. The third test will be performed at ambient temperature outside the chamber.
The order will be determined by random allocation. Participants will undergo the Treadmill 6 Minute Walk Test; various measurements will be taken, all of which will be non-invasive.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Randomised Controlled Trial of an Air Warming Mask to Increase Exercise Tolerance in Patients With Stable and Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD).|
- The primary outcome measure for the study is the difference between forced expiratory volume in one second (FEV1) in litres per second before and after a 6 minute walk. [ Time Frame: 2 hours ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Using mask that warms air at the mouth by utilising body heat
Device: Air warming mask
Mask that warms air at the mouth
No Intervention: No mask
Not using any mask that warms air at the mouth by utilising body heat
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02266316
|Contact: Roy Kennedy, PhD||+00 44 (0)1905 firstname.lastname@example.org|
|University of Worcester||Recruiting|
|Worcester, Worcestershire, United Kingdom, WR2 6AJ|
|Contact: Louise Robertson, MSc +00 44 (0)1905 855204 email@example.com|
|Principal Investigator:||Roy Kennedy, PhD||University of Worcester|