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| Name | Class |
|---|---|
| Asthma UK | OTHER |
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
| King's College Hospital NHS Trust | OTHER |
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The overall aim of this study is to determine if face masks that can warm and humidify air can improve overall asthma control and markers of airway health during exercise in cold dry environments. We will investigate the potential protective benefits of the face masks against exercise induced asthma during 1) a "one-off" bout of exercise in a cold dry environment and 2) over the course of a four week period, exercising three times per week in a cold dry environment.
Physical activity is recognised as a trigger for individuals with asthma, however regular physical activity is considered to be important in the overall management of the condition. There is clear evidence that demonstrates if individuals with asthma engage with regular physical activity they will improve their physical fitness and breathing control, whilst at the same time experiencing reductions in asthma severity, symptoms, and medication use. In addition undertaking regular exercise reduces the risk of developing other diseases such as heart disease or type 2 diabetes. Despite the clear health benefits of engaging in regular physical activity there is evidence that some people with asthma avoid physical activity due to shortness of breath, worsening asthma symptoms during physical activity or fear of experiencing such symptoms.
Physical activity in cold dry environments exacerbates symptoms for many individuals with asthma resulting in greater avoidance of physical activity during the winter months. The increased risk of asthma from exercising in cold environments has led to Asthma UK advising susceptible individuals to avoid exercise outside in cold environments (http://www.asthma.org.uk/advice-exercise). This places obvious constraints and limitations on individuals with asthma for whom the aim of optimum treatment is to allow them to follow a "normal" lifestyle. Indeed, exposure to cold air on exertion is relevant to a significant proportion of individuals with asthma who engage with outdoor physical activity as part of their daily routine; e.g. cycle-commuting to work, outdoor construction workers.
A mask that is able to warm and humidify the air during exercise may provide a solution for asthmatic individuals susceptible to cold dry environments. There are a limited number of small studies that provide tentative evidence suggesting masks which warm and humidify air can protect against reductions in lung function during and following physical activity. However, it is unknown whether the use of these masks provides protection against the mechanisms that drive asthmatic symptoms. It is also unclear whether using the masks over a prolonged period of time significantly reduces asthma severity, inhaler use, or presence of symptoms.
The overall aim of this study is to determine if face masks that can warm and humidify air can improve overall asthma control and markers of airway health during exercise in cold dry environments. We will investigate the potential protective benefits of the face masks against exercise induced asthma during 1) a "one-off" bout of exercise in a cold dry environment and 2) over the course of a four week period, exercising three times per week in a cold dry environme
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HME MASK | Experimental | During the Exercise, participants wore either an HME mask (MASK) (ColdAvenger® expedition balaclava, USA, www.coldavenger.com) |
|
| SHAM mask | Sham Comparator | a sham mask (SHAM) which was the same HME mask with holes cut across the entire ventilator cup and the ventilator removed |
|
| Control | No Intervention | No mask (CONT) wearing only the balaclava to which the HME and SHAM mask were attached. Mouth and face not covered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA, | Device | A heat and moisture exchange mask will warm and humidify inspired air and therefore reduce airway heat and water loss during exercise. This will potentially reduce the incidence of and severity of EIB and may also have the potential to decrease the incidence of cough amongst athletes engaging in sports in cold dry environments |
| Measure | Description | Time Frame |
|---|---|---|
| % fall in FEV1 | Change in Forced Expiratory Volume in One Second from baseline to post exercise | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| coughs per hour after EX | Number of coughs per hour in a 24 hour period after exercise | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Chest infection within the past 4 weeks, or any other illness within the past 2 weeks
Fall in FEV1 >50% from baseline following exercise challenge (see protocol)
Baseline FEV1 of < 80% of predicted
Cardiovascular conditions:
Metabolic diseases:
Daily use of oral corticosteroids
Hospitalisation due to asthma in the six months prior to study commencement
Injury or conditions that limit mobility
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| John W Dickinson, PhD | University of Kent | Principal Investigator |
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| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D000092202 | Exercise-Induced Allergies |
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randomised cross-over design
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Heat Exchange Mask SHAM Mask
|
| Sham treatment | Device | Same as the HME mask but active HME parts withdrawn from devices and multiple holes made in mouth piece to improve ventilation of mask and reduce HME ability of mask |
|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |