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Use of an Air Warming Mask for Exercise in Patients With COPD V1.0

NCT02266316 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-10-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Air warming mask

Mask that warms air at the mouth

Sponsors & Collaborators

  • University of Worcester

    lead OTHER

Principal Investigators

  • Roy Kennedy, PhD · University of Worcester

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266316 on ClinicalTrials.gov