Condition category
Respiratory
Date applied
08/05/2017
Date assigned
09/05/2017
Last edited
08/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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)

Trial website

Contact information

Type

Public

Primary contact

Dr Linda Eriksson

ORCID ID

http://orcid.org/0000-0003-3739-0084

Contact details

Department of Public Health and Clinical Medicine
c/o Dr Stenfors
Story 5
House 10
Hospital of Östersund
Umeå
SE-901 87
Sweden

Type

Scientific

Additional contact

Dr Nikolai Stenfors

ORCID ID

Contact details

Department of Public Health and Clinical Medicine
Story 5
House 10
Hospital of Östersund
Östersund
SE-831 83
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

H7/H8

Study information

Scientific title

In healthy individuals, do moderate-hard physical activity in sub-zero temperature damage the airways (measured by lung function and biochemical markers)?

Acronym

Study hypothesis

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

The Regional Ethics Board of Umeå. Department of Medical Research, 22/06/2016, ref: Dnr 2016-203-31M

Study design

Single-centre interventional randomised double-blind cross over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet (only available in Swedish)

Condition

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.

Intervention type

Other

Phase

Drug names

Primary outcome measures

CC16 levels, assessed using blood and urine samples taken immediately before and 60 minutes after the exposures

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 trial start date

01/01/2016

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy volunteer
2. Age 18-65
3. No allergy or asthma
4. Never regular smoker

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

30+30

Participant 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)

Recruitment start date

01/09/2016

Recruitment end date

31/03/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

The Swedish Winter Sports Research Centre, Mid Sweden University
Östersund
SE-831 25
Sweden

Sponsor information

Organisation

Umeå University

Sponsor details

-
Umeå
SE-901 87
Sweden
+46 (0)90 786 50 00
umea.universitet@umu.se

Sponsor type

University/education

Website

http://www.umu.se/english

Funders

Funder type

Not defined

Funder name

VISARE NORR Fund, Northern Country Councils Regional Federation

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

Syskonen Perssons Donationsfond

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

ARCUM, Arctic Research Centre at Umeå University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Anna Cederbergs Stiftelse för Medicinsk Forskning

Alternative name(s)

Anna Cederberg's Foundation for Medical Research, Anna Cederberg Foundation for Medical Research, Anna Cederbergs Stiftelse, Anna Cederberg Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Funder name

The Swedish Winter Sports Research Centre, Mid Sweden University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 is 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.

Intention to publish date

01/05/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes