Plain English Summary
Background and study aims
Physical activity in sub-zero temperatures may induce bronchial obstruction in healthy subjects. Cold-weather endurance athletes, such as cross-country skiers, have an increased prevalence of asthma. Little is known about whether breathing masks prevent airway damage in winter endurance athletes. The aim is to investigate the effect of breathing mask usage during intense physical exercise in cold air on markers of airway damage as well as physiological and perceptual responses to exercise in the cold.
Who can participate?
Well-trained adults with experience of treadmill-running, without asthma, allergy, or breathing problems.
What does the study involve?
The exposures will take place in -15 °C on two separate occasions at least 48 hours apart. Throughout one of the two exposures, study subjects will use a heat-exchanging breathing mask.
Each exposure will last 45 minutes and consist of an exercise protocol to simulate a prolonged warm-up and 4 minutes long “distance-trial” of running.
Symptoms will be reported immediately pre, during, and immediately after exiting the chamber. Dynamic spirometry and impulse oscillometry will be conducted before and immediately after each exposure. Participants will provide blood and urine samples pre and 60 minutes post-exposure for analysis of biochemical markers of airway damage. Performance will be evaluated as the distance achieved during 4 minutes of running.
What are the possible benefits and risks of participating?
We assume the exposures and associated exercise protocol will induce acute symptoms such as fatigue, dyspnea, rhinitis, and cough that will resolve within 15 minutes after exiting the chamber. We do not expect tissue injury or frostbite to occur. Venepuncture will induce local
pain. Spirometry requires 3-8 forced expiratory manoeuvres which may feel strenuous. We do not expect that exposures nor the measurements will cause any long-term harm for the participants.
Where is the study run from?
1. The Swedish Winter Sports Research Centre, Mid Sweden University, Östersund, Sweden
2. Public Health and Clinical Medicine Umeå University, Umeå, Sweden
When is the study starting and how long is it expected to run for?
January to June 2019
Who is funding the study?
1. The siblings Persson's fund, Region Jämtland Härjedalen
2. Unit of Research, Education and Development, Region Jämtland Härjedalen
3. Gunhild and Assar Carlsson's fund, Region Jämtland Härjedalen
Who is the main contact?
Mr Hampus Persson, hampus.persson@regionjh.se
Trial website
Contact information
Type
Public
Primary contact
Mr Hampus Persson
ORCID ID
http://orcid.org/0000-0003-0598-3037
Contact details
Kyrkgatan 16
Östersund
83131
Sweden
004663153000
hampus.persson@regionjh.se
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Version 1 (2018-11-02)
Study information
Scientific title
In healthy subjects, do heat and moisture exchange mask attenuate airway effects of physical activity in subzero temperature?
Acronym
AEGIS3
Study hypothesis
What is the effect of use versus non-use of a heat-moisture exchanging breathing mask (HME) during moderate to severe-intensity exercise in the cold with regard to; respiratory function, biomarkers of airway damage, respiratory symptoms, heart rate, breathing rate, muscle oxygenation, perceived exertion during exercise, and exercise performance?
Ethics approval
Approved 20/12/2018, Regional Ethical Review Board at Umeå University (Regionala etikprövningsnämnden, Samverkanshuset, Universitetsområdet, 901 87 Umeå; epn@adm.umu.se; +4690 7867254), ref: 2018-419-31M
Study design
2x2 cross-over study
Primary study design
Interventional
Secondary study design
2x2 cross-over study
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Airway injury
Intervention
Current interventions as of 20/06/2019:
All participants will complete two standardized 45-minutes exercises in an environmental chamber with a temperature of - 15 degrees Celsius, one exercise with a HME and one without HME.
The exercise protocol will simulate a prolonged warm-up and 4 minutes long “distance-trial” of running.
1. Chamber environment: automatic digital logging
2. Symptoms: self-reported written questionnaires
3. Spirometry: digital
4. Biochemical makers: Manual export of data from paper sheets with results into digital files.
5. Heart rate, breathing rate, muscle oxygenation, performance: Manual data collection, export into digital files
Previous interventions:
All participants will complete two standardized 45-minutes exercises in an environmental chamber with a temperature of - 15 degrees Celsius, one exercise with a HME and one without HME.
The exercise protocol will simulate a prolonged warm-up and sprint-ski competition.
1. Chamber environment: automatic digital logging
2. Symptoms: self-reported written questionnaires
3. Spirometry: digital
4. Biochemical makers: Manual export of data from paper sheets with results into digital files
5. Pexa: Manual export of data from paper sheets with results into digital files
6. Heart rate, breathing rate, muscle oxygenation, performance: Manual data collection, export into digital files
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measure
Delta-FEV1 (forced expiratory volume first second), measured by dynamic spirometry. Delta-FEV1 is FEV1 immediately post exposure minus FEV1 pre exposure. Delta-FEV1 with HME compared to delta-FEV1 without HME.
Secondary outcome measures
Current secondary outcome measures as of 20/06/2019:
1. Delta airway resistance (immediately post - pre exposure) using impulse oscillometry
2. Airway symptoms using questionnaires, pre, during, and post exposures
3. Biochemical markers of airway damage (CC-16 and interleukins, not yet specified) measured in blood samples pre and 60 minutes post exposures
4. Urine CC-16 measured pre and 60 minutes post exposures
5. Heart rate and breathing rate measured during exposures
6. Muscle oxygenation measured during exposures using (MOXY muscle oxygen monitor, Fortiori design LLC, Minnesota, USA)
7. Performance will be defined as distance covered by a 4 minutes long sprint of running
Previous secondary outcome measures:
1. Delta airway resistance (immediately post - pre exposure) using impulse oscillometry
2. Airway symptoms using questionnaires, pre, during, and post exposures
3. Biochemical markers of airway damage (CC-16, 8-isoprostane, IL-1β, IL-6, and TNF-α) measured in blood samples pre and 60 minutes post exposures
4. Urine CC-16 measured pre and 60 minutes post exposures
5. Particles in exhaled breath using PExA instrument, pre and immediately post exposures
6. Heart rate and breathing rate measured during exposures
7. Muscle oxygenation measured during exposures using (MOXY muscle oxygen monitor, Fortiori design LLC, Minnesota, USA)
8. Performance will be defined as the time taken to complete the TT
Overall trial start date
12/06/2018
Overall trial end date
30/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 20/06/2019:
1. Healthy, well-trained adults
2. Experience of treadmill running
Previous inclusion criteria:
1. Healthy, competitive cross-country skier
2. > 3 years training experience and should be experienced in treadmill roller-skiing using the classical diagonal stride technique
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. No reported airway infection within 4 weeks prior to each visit
2. Asthma, lung diseases and other diseases that may significantly affect their physical performance status
Recruitment start date
01/01/2019
Recruitment end date
31/05/2019
Locations
Countries of recruitment
Sweden
Trial participating centre
The Swedish Winter Sports Research Centre, Mid Sweden University
Studentplan 4
Östersund
831 40
Sweden
Trial participating centre
Public Health and Clinical Medicine Umeå University
Umeå
901 87
Sweden
Sponsor information
Organisation
Mid Sweden University
Sponsor details
The Swedish Winter Sports Research Centre
Campus Kunskapens väg 8
Östersund
83125
Sweden
004610142 80 00
kontakt@miun.se
Sponsor type
University/education
Website
Organisation
Public Health and Clinical Medicine Umeå University
Sponsor details
Förvaltningshuset House D
Umeå
901 87
Sweden
0046 90 786 50 00
registrator@umu.se
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The siblings Persson's fund, Region Jämtland Härjedalen
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Unit of Research, Education and Development, Region Jämtland Härjedalen
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Gunhild and Assar Carlsson's fund, Region Jämtland Härjedalen
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal. One manuscript is planned for 2020 and the second during 2020-2021.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
01/12/2021
Participant level data
Available on request
Basic results (scientific)
Publication list