Condition category
Respiratory
Date applied
25/01/2019
Date assigned
06/02/2019
Last edited
29/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

http://www.tauernhealth.com/

Contact information

Type

Scientific

Primary contact

Dr Arnulf Hartl

ORCID ID

Contact details

Strubergasse 22
Salzburg
5020
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

415-E/1553/2-2012

Study information

Scientific title

Winter exercise and speleotherapy for allergy and asthma - the WESPAA study

Acronym

WESPAA

Study hypothesis

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

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

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

01/10/2012

Overall trial end date

28/02/2014

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant 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

Recruitment start date

19/11/2012

Recruitment end date

15/02/2013

Locations

Countries of recruitment

Austria, Germany

Trial participating centre

Paracelsus Medical University Salzburg
Institute of Ecomedicine Strubergasse 22
Salzburg
5020
Austria

Sponsor information

Organisation

Paracelsus Medical University

Sponsor details

Research Office
Strubergasse 21
Salzburg
5020
Austria

Sponsor type

University/education

Website

https://www.pmu.ac.at/

Funders

Funder type

Government

Funder name

Austrian Federal Ministry of Economic Affairs, Family and Youth

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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.

Intention to publish date

01/03/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes