Cold air, physical activity and the airways
| ISRCTN | ISRCTN79432558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79432558 |
| Secondary identifying numbers | H7/H8 |
- Submission date
- 08/05/2017
- Registration date
- 09/05/2017
- Last edited
- 15/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Studies have shown that exposure to sub-zero temperatures is associated with increased morbidity (illness) and mortality (death). People with lung diseases are a particularly vulnerable group. Elite skiers are frequently exposed to cold, dry air and have an increased prevalence of asthma. The prevalence of asthma is 9% in the Swedish population and around 30% among Swedish elite skiers. This study aims to find out whether exercise in -10°C causes more airway symptoms, airway obstruction and higher levels of a marker of airway damage (CC16), compared to exercise in +10°C. The study also aims to find out whether exercise in -15°C, as compared to rest, causes more airway symptoms, airway obstruction and higher levels of CC16.
Who can participate?
Healthy volunteers aged 18-65
What does the study involve?
In the pre-test participants’ oxygen uptake and heart rate are measured during a treadmill running test. In the first sub-study, participants are randomly allocated to run on a treadmill in a cold chamber at either +10°C or -10°C. Participants repeat the test at least one week later at the other temperature. In the second sub-study, participants are randomly allocated to either run on a treadmill or be at rest in a cold chamber at -15°C. Participants repeat the test at least one week later performing the other activity. Each test lasts 60 minutes. During each test the participants fill out questionnaires about their symptoms. Before and after each test participants’ lung function is assessed and markers of airway damage are measured by taking blood and urine samples.
What are the possible benefits and risks of participating?
The participants receive financial compensation of about £90 (SEK 1000). The pre-test requires exercise to exhaustion which may be uncomfortable for participants who do not frequently undertake high-intensity exercise. Oxygen uptake is measured using a mouthpiece and nose clip that might cause a little discomfort during exercise. Exposure to sub-zero temperatures is expected to cause short-lived cold-related symptoms. Blood sampling causes short-lived pain at the site of vein puncture. The lung function tests involve several large exhalations which may feel exhaustive in the moment.
Where is the study run from?
Swedish Winter Sports Research Centre, Mid Sweden University (Sweden)
When is the study starting and how long is it expected to run for?
January 2016 to June 2018
Who is funding the study?
1. VISARE NORR Fund, Northern Country Councils Regional Federation (Sweden)
2. Unit of Research, Education and Development, Region Jämtland Härjedalen (Sweden)
3. Syskonen Perssons Donationsfond (Sweden)
4. ARCUM, Arctic Research Centre at Umeå University (Sweden)
5. Anna Cederbergs Stiftelse (Sweden)
6. The Swedish Winter Sports Research Centre, Mid Sweden University (Sweden)
Who is the main contact?
1. Dr Linda Eriksson (public)
2. Dr Nikolai Stenfors (scientific)
Contact information
Public
Department of Public Health and Clinical Medicine
c/o Dr Stenfors
Story 5, House 10
Hospital of Östersund
Umeå
SE-901 87
Sweden
 ORCID ID |
0000-0003-3739-0084 |
|---|
Scientific
Department of Public Health and Clinical Medicine
Story 5, House 10
Hospital of Östersund
Östersund
SE-831 83
Sweden
Study information
| Study design | Single-centre interventional randomised double-blind cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet (only available in Swedish) |
| Scientific title | In healthy individuals, do moderate-hard physical activity in sub-zero temperature damage the airways (measured by lung function and biochemical markers)? |
| Study objectives | 1. Does running in -10°C in a cold chamber cause airway symptoms, airway obstruction, and raised levels of CC16 in blood and urine? 2. Does moderate-hard physical exercise during exposure for -15°C cause, as compared to rest, more airway symptoms, airway obstruction, and higher levels of CC16 in blood and urine? 3. Are there correlations between symptoms triggered by cold temperature, airway obstruction, and levels of CC16 in blood and urine? |
| Ethics approval(s) | The Regional Ethics Board of Umeå. Department of Medical Research, 22/06/2016, ref: Dnr 2016-203-31M |
| Health condition(s) or problem(s) studied | Airway injury |
| Intervention | The study includes 60 healthy individuals, 30 in each sub-study (H7 and H8). Before the exposures, the participants perform a pre-test consisting of an incremental treadmill running protocol until exhaustion. Oxygen uptake and heart rate will be measured throughout the test. Based on the test the participant's VO2 max (maximum oxygen uptake) is calculated. The experimental cold exposures are performed in a cold chamber at the Swedish Winter Sports Research Centre, Mid Sweden University, Östersund, Sweden. Each exposure is 60 minutes. In sub-study one (H7) the participants are exposed to +10°C and -10°C in randomised order, with at least one week in between the occasions. During the exposures, they run on a treadmill at 60-85% of their VO2 max. In sub-study two (H8) the participants are exposed to -15°C at two occasions with at least one week in between. During one exposure they are at rest and during one exposure they run on a treadmill at 60-85% of their VO2 max. Before, during, and after the exposures the participants complete questionnaires regarding symptoms. Immediately before and after the exposures the participants undergo dynamic spirometry and impulse oscillometry. Blood and urine samples are taken immediately before and 60 minutes after the exposures. The blood is sent for the analysis of cell differential count and CC16 and the urine is sent for the analysis of creatinine and CC16. Added 10/06/2019: A sample size calculation has been conducted using ΔFEV1 as the primary outcome variable. It is assumed that mean (SD) FEV1 will be 4.58 (0.40) L, and that exercise in -15°C without a breathing mask will decrease FEV1 by 6% (Kennedy and Faulhaber, 2018; Therminarias et al., 1998). The researchers assume equal variance of FEV1 and a correlation of 0.3 between both exposures. The null hypothesis is no difference in the reduction of FEV1 post exposures and they reject the null hypothesis at a 6% reduction of FEV1. With alpha at 0.05 and beta at 0.20, 20 study subjects are required. In statistical analyses, consideration will be taken that the observations are dependent and that there are multiple measurements. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 10/06/2019: Forced expiratory volume in one second (FEV1) - a measure of lung function, assessed using dynamic spirometry and impulse oscillometry immediately before and after the exposures Previous primary outcome measure: CC16 levels, assessed using blood and urine samples taken immediately before and 60 minutes after the exposures |
| Secondary outcome measures | Current secondary outcome measures as of 10/06/2019: 1. General symptoms and symptoms of the upper and lower airways, assessed using two validated questionnaires before, during (after 10, 30 and 45 minutes), and after the exposures 2. CC16 levels, assessed using blood and urine samples taken immediately before and 60 minutes after the exposures 3. Systemic inflammatory response, assessed by taking blood samples for cell differential count immediately before and 60 minutes after the exposures Previous secondary outcome measures: 1. General symptoms and symptoms of the upper and lower airways, assessed using two validated questionnaires before, during (after 10, 30 and 45 minutes), and after the exposures 2. Lung function, assessed using dynamic spirometry and impulse oscillometry immediately before and after the exposures 3. Systemic inflammatory response, assessed by taking blood samples for cell differential count immediately before and 60 minutes after the exposures |
| Overall study start date | 01/01/2016 |
| Completion date | 30/06/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 20+20 |
| Total final enrolment | 76 |
| Key inclusion criteria | 1. Healthy volunteer 2. Age 18-65 3. No allergy or asthma 4. Never regular smoker |
| Key exclusion criteria | 1. Asthma 2. Allergy 3. Cardiovascular disease 4. Anti-inflammatory medication 5. Regular smoker or former regular smoker 6. <18 or >65 years of age 7. Recent airway infection (<4 weeks prior to pretests and exposures) |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 30/04/2018 |
Locations
Countries of recruitment
- Sweden
Study participating centre
SE-831 25
Sweden
Sponsor information
University/education
-
Umeå
SE-901 87
Sweden
| Phone | +46 (0)90 786 50 00 |
|---|---|
| umea.universitet@umu.se | |
| Website | http://www.umu.se/english |
"ROR" |
https://ror.org/05kb8h459 |
Funders
Funder type
Not defined
No information available
No information available
No information available
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Anna Cederberg's Foundation for Medical Research, Anna Cederberg Foundation for Medical Research, Anna Cederberg Foundation, Anna Cederbergs Stiftelse
- Location
- Sweden
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publication of the results in articles in medical scientific journals during 2018-2019. The articles will be part of a thesis with planned dissertation in 2021. |
| IPD sharing plan | The data generated during and/or analysed during the current study are not expected to be made available due to a requirement in the ethical approval, where there is a statement that the data will not be shared with unauthorized persons. The data will be held at a server at Umeå University. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 25/06/2019 | 25/06/2019 | No | No | |
| Results article | 08/03/2021 | 15/09/2021 | Yes | No |
Additional files
- ISRCTN79432558_BasicResults_25Jun2019.pdf
- uploaded 25/06/2019
Editorial Notes
15/09/2021: Publication reference added.
09/12/2020: The intention to publish date was changed from 30/06/2020 to 31/12/2021.
25/06/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2019 to 30/06/2018.
2. The total final enrolment was changed from 60 to 76.
3. The basic results of this trial have been uploaded as an additional file.
14/06/2019: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2018 to 30/06/2019.
2. The intention to publish date was changed from 30/06/2019 to 30/06/2020.
14/06/2019: The target number of participants was changed from 30+30 to 20+20 and the total final enrolment number was added.
10/06/2019: The interventions and primary and secondary outcome measures were updated.
28/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2018 to 30/04/2018.
2. The intention to publish date was changed from 01/05/2018 to 30/06/2019.
