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

NCT02266316 | Unknown

• 1 other identifier: WARM/COPD/1112
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours

Study Arms (2)

Mask

EXPERIMENTAL

Using mask that warms air at the mouth by utilising body heat

Device: Air warming mask

No mask

NO INTERVENTION

Not using any mask that warms air at the mouth by utilising body heat

Interventions

Air warming mask DEVICE

Mask that warms air at the mouth

Mask

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Worcester: lead

Study Sites (1)

University of Worcester

Worcester, Worcestershire, WR2 6AJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roy Kennedy, PhD

  University of Worcester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roy Kennedy, PhD

CONTACT

+00 44 (0)1905 855255; r.kennedy@worc.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 17, 2014
• Study Start: March 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 17, 2014

Record last verified: 2014-10

Locations

GB (1)