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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by University of Worcester.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02266316
First Posted: October 17, 2014
Last Update Posted: October 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Worcester
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease Device: Air warming mask

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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).

Resource links provided by NLM:


Further study details as provided by University of Worcester:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
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)
Arms Assigned Interventions
Experimental: Mask
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females diagnosed with COPD, GOLD stage 2 to stage 4
  • Stable COPD
  • ≥40 years old
  • Ability to walk for 6 minutes without stopping
  • Medical Research Council (MRC) scale of dyspnoea - grade 3 or above (grade 3 means a patient is limited to walking slower than contemporaries on the level because of breathlessness, or has to stop for breath when walking at own pace).

Exclusion Criteria:

  • Significant disease other than COPD
  • Ischaemic heart disease
  • Use of supplemental oxygen therapy
  • Participants who are unable to walk
  • Unstable or life-threatening cardiac arrhythmia
  • History of myocardial infarction
  • Cold, flu like illness, or other chest infection in the last 8 weeks
  • Participants who are currently experiencing an exacerbation of their COPD
  • Participants who have experienced an exacerbation in the previous 8 weeks
  • Participants who have a known reaction to medical plastics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266316


Contacts
Contact: Roy Kennedy, PhD +00 44 (0)1905 855255 r.kennedy@worc.ac.uk

Locations
United Kingdom
University of Worcester Recruiting
Worcester, Worcestershire, United Kingdom, WR2 6AJ
Contact: Louise Robertson, MSc    +00 44 (0)1905 855204    l.robertson@worc.ac.uk   
Sponsors and Collaborators
University of Worcester
Investigators
Principal Investigator: Roy Kennedy, PhD University of Worcester
  More Information

Responsible Party: University of Worcester
ClinicalTrials.gov Identifier: NCT02266316     History of Changes
Other Study ID Numbers: WARM/COPD/1112
First Submitted: October 10, 2014
First Posted: October 17, 2014
Last Update Posted: October 17, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases


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