Heat-exchanger breathing masks during heavy exertion in cold conditions; protection or a hindrance?
| ISRCTN | ISRCTN10018222 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10018222 |
| Secondary identifying numbers | Version 1 (2018-11-02) |
- Submission date
- 27/02/2019
- Registration date
- 01/04/2019
- Last edited
- 01/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
4. Rolf och Gunilla Enström’s foundation for research and development (Östersund, 2022)
5. Mid Sweden University and Östersund City Council financial agreement (2022)
Who is the main contact?
Nikolai Stenfors, nikolai.stenfors@umu.se
Contact information
Public
Kyrkgatan 16
Östersund
83131
Sweden
 ORCID ID |
0000-0002-1684-1301 |
|---|---|
| Phone | +46 63153000 |
| nikolai.stenfors@umu.se |
Study information
| Study design | 2x2 cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | 2x2 cross-over study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | In healthy subjects, do heat and moisture exchange mask attenuate airway effects of physical activity in subzero temperature? |
| Study acronym | AEGIS3 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| 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 01/11/2024: 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 8. Urinary LTE₄ and 11β-PGF2α pre and 60 min post exposure _____ Previous 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 study start date | 12/06/2018 |
| Completion date | 30/06/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 23 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 31/05/2019 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Östersund
831 40
Sweden
901 87
Sweden
Sponsor information
University/education
The Swedish Winter Sports Research Centre
Campus Kunskapens väg 8
Östersund
83125
Sweden
| Phone | 004610142 80 00 |
|---|---|
| kontakt@miun.se | |
| Website | https://www.miun.se |
"ROR" |
https://ror.org/019k1pd13 |
University/education
Förvaltningshuset House D
Umeå
901 87
Sweden
| Phone | 0046 90 786 50 00 |
|---|---|
| registrator@umu.se | |
| Website | https://www.umu.se/en/ |
Funders
Funder type
Charity
No information available
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/03/2021 | 17/08/2022 | Yes | No | |
| Results article | 07/04/2022 | 17/08/2022 | Yes | No |
Editorial Notes
01/11/2024: The following changes were made to the trial record:
1. The contact was changed.
2. The secondary outcome measures were changed.
3. The funders Rolf och Gunilla Enström’s foundation for research and development (Östersund, 2022) and Mid Sweden University and Östersund City Council financial agreement (2022) were added.
17/08/2022: Publication reference and total final enrolment added.
05/06/2020: The intention to publish date was changed from 01/12/2019 to 01/12/2021.
20/06/2019: The interventions, secondary outcome measures, and inclusion criteria were updated.
18/03/2019: Trial’s existence confirmed by IRB.
