Condition category
Respiratory
Date applied
27/02/2019
Date assigned
01/04/2019
Last edited
18/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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?
Adult competitive cross-country skiers, with at least 3 years experience of treadmill-roller skiing, without asthma 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 sprint-ski competition.
Symptoms will be reported immediately pre, during, and immediately after exiting the chamber. Dynamic spirometry and impulse oscillometry will be conducted immediately before and after each exposure. Participants will provide blood, urine and exhaled breath samples pre and 60 minutes post-exposure for analysis of biochemical markers of airway damage. Performance will be evaluated as the time taken to complete the sprint ski trial.

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 May 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

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.

Chamber environment: automatic digital logging
Symptoms: self-reported written questionnaires
Spirometry: digital
Biochemical makers: Manual export of data from paper sheets with results
into digital files.
Pexa: Manual export of data from paper sheets with results
into digital files.
Heart rate, breathing rate, muscle oxygenation, performance: Manual data collection, export into
digital files

Intervention type

Device

Phase

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

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

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 thay 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

The Swedish Winter Sports Research Centre, Mid Sweden University

Sponsor details

Campus Kunskapens väg 8
Östersund
83125
Sweden
004610142 80 00
kontakt@miun.se

Sponsor type

University/education

Website

https://www.miun.se

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

https://www.umu.se/en/

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 2019 and the second during 2020.

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

01/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/03/2019: Trial’s existence confirmed by IRB