Screening of exercise-induced asthma using exercise in subzero temperature air
| ISRCTN | ISRCTN12919627 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12919627 |
| Secondary identifying numbers | Version 1, 2022-04-20 |
- Submission date
- 20/09/2022
- Registration date
- 29/09/2022
- Last edited
- 16/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Winter sports athletes have a high prevalence of physician-diagnosed asthma. In athletes, the diagnosis often requires objective tests for bronchial hyperresponsiveness (BHR)/exercise-induced bronchoconstriction (EIB), key components of asthma. The exercise-challenge test is the most specific challenge test for athletes. However, we have very little knowledge of the prevalence of BHR/EIB to exercise challenges in subzero temperature air, a common environment for winter sports athletes.
Who can participate?
Current or former students at Swedish National Elite Sports Schools in cross-country skiing and biathlon participating in a survey on heat- and moisture-exchanging breathing masks, airway symptoms, and asthma 2022-2023 and from 2024 students at Swedish National Elite Sports Schools in cross-country skiing and biathlon
What does the study involve?
Exercise-challenge test at -15 degrees Celsius. FeNO, blood and urine sampling, and lung function tests.
What are the possible benefits and risks of participating?
The possible benefits include the diagnosis of BHR/EIB to exercise and cold air. The possible risks include exercise- and cold air-induced discomfort, and local pain from venipuncture.
Where is the study run from?
Umeå University (Sweden)
When is the study starting and how long is it expected to run for?
January 2021 to December 2026
Who is funding the study?
1. Regional Government Jämtland Härjedalen (Sweden)
2. Swedish Heart-Lung Foundation (Sweden)
Who is the main contact
Dr Nikolai Stenfors
nikolai.stenfors@umu.se
Contact information
Principal Investigator
Building 10
5th floor
Östersund hospital
Östersund
83183
Sweden
 ORCID ID |
0000-0002-1684-1301 |
|---|---|
| Phone | +46 70 6092778 |
| nikolai.stenfors@umu.se |
Study information
| Study design | Single-centre prospective screening study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | University/medical school/dental school, Other |
| Study type | Screening |
| Participant information sheet | 42467 PIS v3.0 17June2021 05_a4_forskningspersonsinformation_k2021.pdf |
| Scientific title | Screening of exercise-induced bronchoconstriction using exercise challenge in subzero temperature air |
| Study acronym | Aegis 4 |
| Study objectives | Estimate the prevalence of exercise-induced bronchoconstriction in cross-country skiers using exercise challenge in subzero temperature air |
| Ethics approval(s) | Approved 01/06/2022, Swedish Ethical Review Authority (Box 2110, 750 02 Uppsala, Sweden, +46 10 475 08 00, registrator@etikprovning.se, ref: 2021-02660 |
| Health condition(s) or problem(s) studied | Exercise-induced bronchoconstriction |
| Intervention | Current interventions as of 16/09/2024: Study participants were invited by randomization from a list of study subjects participating in a web survey on airway symptoms and asthma among cross-country skiers 2022-2023. From 2024 study participants are invited by an open invitation to all Swedish National Sport schools in biathlon and cross-country skiers. Exercise challenge for 8 minutes on a treadmill at -15 Celsius, ~65 % relative humidity and absolute humidity around 1.3g/m3, in an environmental chamber. The exercise challenge involves a rapid increase in treadmill speed and inclination with a target heart rate of >85% (group 1) or >95% (group 2) of the predicted maximum (220-age in years). The target heart rate is maintained for 4-6 minutes. Previous interventions as of 07/09/2023: Study participants were invited by randomization from a list of study subjects participating in a web survey on airway symptoms and asthma among cross-country skiers. Exercise challenge for 8 minutes on a treadmill at -15 Celsius, ~65 % relative humidity and absolute humidity around 1.3g/m3, in an environmental chamber. The exercise challenge involves a rapid increase in treadmill speed and inclination with a target heart rate of >85% (group 1) or >95% (group 2) of the predicted maximum (220-age in years). The target heart rate is maintained for 4-6 minutes. Previous interventions: Study participants were invited by randomization from a list of study subjects participating in a web survey on airway symptoms and asthma among cross-country skiers. Exercise challenge for 8 minutes on a treadmill at -15 Celsius, ~65 % relative humidity and absolute humidity around 1.3g/m3, in an environmental chamber. The exercise challenge involves a rapid increase in treadmill speed and inclination with a target heart rate of >85% of the predicted maximum (220-age in years). The target heart rate is maintained for 4-6 minutes. |
| Intervention type | Other |
| Primary outcome measure | Prevalence of exercise-induced bronchoconstriction, defined as the maximal reduction in FEV1 of >= 10%, measured using dynamic spirometry 5, 10, 15, 20, and 30 minutes post challenge |
| Secondary outcome measures | Prevalence of exercise-induced bronchoconstriction, defined as the maximal increase in airway resistance (R5) of >= 40%, measured using impulsoscillometry at 3,8,13,18, and 28 minutes post challenge |
| Overall study start date | 01/01/2021 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Current or former students at Swedish National Elite Sports Schools in cross-country skiing and biathlon participating in a survey on heat- and moisture-exchanging breathing masks, airway symptoms, and asthma. Added 16/09/2024: From 2024 and onwards, eligible subjects are restricted to students at Swedish National sport schools in biathlon and cross-country skiing. |
| Key exclusion criteria | Airway infection within 4 weeks prior to exercise challenge |
| Date of first enrolment | 01/09/2022 |
| Date of final enrolment | 01/11/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Umeå
90187
Sweden
Östersund
83125
Sweden
Östersund
83125
Sweden
Sponsor information
University/education
Department of Medicine
Umeå
90187
Sweden
| Phone | +46 90 7865000 |
|---|---|
| info.folkhalsa@umu.se | |
| Website | https://www.umu.se/english |
"ROR" |
https://ror.org/05kb8h459 |
Funders
Funder type
Government
Government organisation / Local government
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Heart-Lung Foundation
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| 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 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Nikolai Stenfors, nikolai.stenfors@umu.se. Anonymised individual participant data (demographics, lung function, exercise performance, blood/urine samples, questionnaire data and FeNO) can be shared upon request but only for research conducted by Universities and if the research study has been approved by an ethics committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 17/06/2021 | 23/09/2022 | No | Yes |
| Protocol file | 21/04/2021 | 23/09/2022 | No | No |
Additional files
Editorial Notes
16/09/2024: The following changes were made to the study record:
1. The primary study design was changed from Interventional to Observational.
2. The secondary study design was changed from Prospective screening to Cross sectional study.
3. University/medical school/dental school was added to the study settings.
4. The interventions, inclusion criteria and plain English summary were updated.
07/09/2023: The interventions were updated.
23/09/2022: Trial's existence confirmed by the Swedish Ethical Review Authority.
