Effects of winter exercise and the healing climate of caves on people with allergies and asthma

ISRCTN	ISRCTN88277657
DOI	https://doi.org/10.1186/ISRCTN88277657
Secondary identifying numbers	415-E/1553/2-2012

Submission date: 25/01/2019
Registration date: 06/02/2019
Last edited: 22/03/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The prevalence of allergic rhinitis (hay fever) and asthma has increased during the last decades. Therefore, allergies have become an enormous economic burden. Allergic diseases influence the quality of life of patients negatively, and in particular quality of sleep is impaired, which is leading to daytime sleepiness, reduced work productivity and worse school performance. The conservative treatment of allergic includes several drugs like antihistamines, bronchodilators and glucocorticoids. Next to this, travels to and/or stays at high altitude have a long tradition in the therapy of asthma and have been described to have positive long-term effects. Another natural treatment method for allergies and asthma is the so-called speleotherapy. Speleptherapy uses the specific microclimate of old mines and caves to treat respiratory diseases. Although, physicians very often recommend regular exercise for patients with allergies and asthma, scientific evidence and evidence-based guidelines are lacking about recreational winter exercise. The aim of this study is to assess the effects of winter exercise and of speleotherapy in combination with winter exercise on patients with allergies and asthma.

Who can participate?
Men and women aged 18-55 with a house dust mite allergy and controlled allergic rhinitis and/or allergic asthma, and moderate skiing skills to meet the demands of the winter exercise program.

What does the study involve?
Participants are randomly allocated into three groups: a control group and two intervention groups (speleo- and exercise group). The intervention groups spent a 10-day winter holiday in the holiday region National Park Hohe Tauern (Austria). The exercise group participated in a whole-day winter sports program and the speleo group spent 1.5 hours every day in a mine and participated in half-day winter sports program. Medical examinations (lung function, blood tests, endurance etc) are performed at the beginning of the study, after the 10-day holiday and after 2 months.

What are the possible benefits and risks of participating?
The direct benefit for the participants is a ten-day winter holiday with exercise and/or speleo therapy. A vacation improves mood and quality of life. As a negative side effect of physical activity, exercise-induced bronchoconstriction (constriction of the airways) may occur.

Where is the study run from?
The Paracelsus Medical University of Salzburg performed this study. All medical examinations were performed by members of the Institute of Ecomedicine from the Paracelsus Medical University of Salzburg. The speleo and exercise program took place in region National Park Hohe Tauern (Austria), the control group receive no intervention and stay at home (Austria).

When is the study starting and how long is it expected to run for?
Intervention group with winter exercise and speleotherapy & control group: March-May 2013
Intervention group with winter exercise: December 2013- February 2014

Who is funding the study?
This research was funded by Lighthouse projects in tourism award 2011 “Year-round destination Hohe Tauern Health", Winner of the 1st price, Austrian Federal Ministry of Economic Affairs, Family and Youth

Who is the main contact?
Dr Arnulf Hartl

Study website

Contact information

Dr Arnulf Hartl
Scientific

Strubergasse 22
Salzburg
5020
Austria

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Winter exercise and speleotherapy for allergy and asthma - the WESPAA study
Study acronym	WESPAA
Study objectives	Winter exercise and winter exercise in combination with the healing climate of mines/caves (speleotherapy) improve allergic airway inflammation in adults suffering from allergic rhinitis and/or allergic asthma. Winter exercise and winter exercise in combination the healing climate of mines/caves improve health related quality of life in adults suffering from allergic rhinitis and/or allergic asthma.
Ethics approval(s)	Ethics Committee of Salzburg, Amt der Salzburger Landesregierung, Postfach 527, 5010 Salzburg, Tel: +43 (0)662 8042 2375, Email: ethikkommission@salzburg.gv.at, 15/11/2012, ref: E1987/5-2016
Health condition(s) or problem(s) studied	Allergy, asthma, respiratory allergies, house dust mite allergy
Intervention	The intervention groups spent a 10-day winter holiday in the Holiday region National Park Hohe Tauern (Austria). The exercise group participated in a whole-day winter sports program and the speleotherapy group spent every day 1.5h in a mine and participated in half-day winter sports program. The control group did not received any intervention.
Intervention type	Mixed
Primary outcome measure	Measured at baseline (day 0), day 10 and day 60: 1. Allergic airway inflammation assessed using exhaled nitric oxide 2. Health related quality of life assessed using RhinAsthma Quality of Life Scale
Secondary outcome measures	Measured at baseline (day 0), day 10 and day 60: 1. Inflammation/allergic inflammation assessed using differential blood count 2. Cardiorespiratory fitness assessed using the 6-Minute Walk Test 3. Lung function assessed using spirometry 4. Allergic inflammation in the upper airways assessed using eosinophilic cell count from nasal lavage 5. Cleaning rate of the upper airways assessed using mucociliary clearance (saccharin test) 6. Allergic symptoms and health status assessed using the Visual Analogue Scale 7. Chronic stress level assessed using the Trierer Inventory for chronic stress (TICS) 8. General health/health-related quality of life assessed using SF-36 9. Asthma control status assessed using Asthma Control Test 10. Health related quality of life for asthma assessed using Asthma Quality of Life Questionnaire 11. Disease-specific health related quality of life assessed using Sinonasale Outcome Test
Overall study start date	01/10/2012
Completion date	28/02/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	Both
Target number of participants	90
Key inclusion criteria	1. Age between 18-55 years 2. House dust mite sensitization (RAST > 2; positive PRICK-Test or total IgE > 0.7 kU/l) 3. Controlled allergic rhinitis and/or allergic asthma 4. Physical ability, including moderate skiing skills, to meet the demands of the exercise program
Key exclusion criteria	1. Uncontrolled asthma (Asthma Control Test < 20) 2. Malignant neoplastic disorders 3. Exercise induced bronchoconstriction 4. Cardiovascular diseases 5. Orthopedic diseases 6. Lung function disorder 7. Acute infection or fever 8. Uncontrolled metabolic diseases 9. Pregnancy
Date of first enrolment	19/11/2012
Date of final enrolment	15/02/2013

Locations

Countries of recruitment

Austria
Germany

Study participating centre

Paracelsus Medical University Salzburg

Institute of Ecomedicine
Strubergasse 22
Salzburg
5020
Austria

Sponsor information

Paracelsus Medical University
University/education

Research Office
Strubergasse 21
Salzburg
5020
Austria

Website	https://www.pmu.ac.at/
"ROR"	https://ror.org/03z3mg085

Funders

Funder type

Government

Austrian Federal Ministry of Economic Affairs, Family and Youth

No information available

Results and Publications

Intention to publish date	01/03/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Study protocol is not published yet – as the protocol is only available in German, it will not be shared. One publication will focus on the effects of winter exercise on people with allergies and asthma and a second publication will focus on the combined effects of speleotherapy and winter exercise.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Arnulf Hartl (arnulf.hartl@pmu.ac.at). Data will be shared after publication; data will be shared for meta-analysis, data will be shared upon request via e-mail; data will be shared only for research purpose; consent from participants was obtained; no ethical or legal restrictions.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Interim results article	Subsection of data	08/06/2019	22/03/2023	Yes	No

Editorial Notes

22/03/2023: Publication reference added.