Radon Balneology and Physical Activity for Osteoporosis Prevention
| ISRCTN | ISRCTN09441803 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09441803 |
| Secondary identifying numbers | E1216/8-2010 |
- Submission date
- 14/01/2014
- Registration date
- 10/02/2014
- Last edited
- 02/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoporosis is a common condition characterized by decreased bone mass leading to increased fracture risk. The economic burden was estimated at 799 million in Austria for 2010 and could increase by 28 % to 1,025 million in 2025. Mountain hiking is a popular form of exercise in the alpine region and a cost effective treatment. Numerous studies have confirmed the effects of exercise programs on bone metabolism and inflammatory markers in postmenopausal women (a high risk group for osteoporosis). Studies have also shown that radon balneotherapy can help reduce pain for patients with degenerative spinal disease, rheumatoid arthritis and ankylosing spondylitis. The aim of the study is to assess whether a combination of exercise and radon balneotherapy works better than exercise only.
Who can participate?
Females and males aged between 50 and 65 who are fit enough to complete a hiking program and can complete German questionnaires.
What does the study involve?
Participants are randomly allocated to one of two groups: exercise and radon balneotherapy or exercise and non radon (dummy) balneotherapy.
Participants have a week long treatment, then 6 weeks off, then another 3 day treatment, and a follow up period of 240 days.
The first treatment includes five 3-4 hours guided GPS monitored mountain hiking tours with a minimum of 300 meters altitude difference per day, and five radon or placebo baths.
The second treatment includes two hiking tours plus two radon or placebo baths.
Participants have blood tests at the start and end of each treatment weeks and 6 months after the last treatment. They also fill in questionnaires each time.
What are the possible benefits and risks of participating?
Benefits are 9 days of free stay, meals and guided hiking tours in an Austrian resort area.
The risks are comparable to that of a standard touristic stay in the alpine regions including spa visits with low dose radon hyperthermia.
Where is the study run from?
Gastein resort area in Salzburg, Austria
When is the study starting and how long is it expected to run for?
The study started in Autumn 2009 and is expected to run until Autumn 2015
Who is funding the study?
Gastein Research Institute, Paracelsus Medical University Salzburg (Austria).
Who is the main contact?
Dr. Arnulf Hartl
arnulf.hartl@pmu.ac.at
Contact information
Scientific
Institute of Physiology and Pathophysiology
Paracelsus Medical University Salzburg
Salzburg
5020
Austria
Study information
| Study design | Double blind randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Patient information can be found at: http://www.radonhealth.at/downloads/anmeldeblatt-und-informierte-einwilligung-v3.pdf |
| Scientific title | Gastein Radon Balneology and Physical Activity for Osteoporosis Prevention: a randomized, placebo controlled intervention study |
| Study objectives | Does a combined exercise, hyperthermia and radon balneology treatment have any impact on central biomarkers for bone remodeling in a study population at the risk age for developing osteoporosis? |
| Ethics approval(s) | Salzburg Ethics Committee (Ethikkommission für das Bundesland Salzburg], 26 May 2010, ref: E1216/8-2010 |
| Health condition(s) or problem(s) studied | Osteporosis prevention |
| Intervention | Exercise +/- Radon balneotherapy Study subjects are allocated by random into a radon group and placebo group Randomization will be computed in blocks of four with an equal treatment allocation ratio. Radon- or placebo thermal-water bath filling is blinded with a personalized digital ID card that provides tub filling with either radon thermal water or radon degassed thermal water (placebo) in an automatic process. In this double blind setting neither the participants nor the bath attendant have knowledge of the composition of the water. |
| Intervention type | Other |
| Primary outcome measure | Plasma levels of OPG for bone formation, RANKL for bone reabsorption and their ratio (OPG/RANKL) as a measure for the balance of bone metabolism Forearm venous blood is collected from all participants at baseline (day 0, timepoint 1; T1), end of first treatment week (day 6, timepoint 2; T2), start and end of the brushup (day 60 and 63, timepoint 3; T3 and timepoint 4; T4) and 6 months after the last treatment (followup, day 240, timepoint 5; T5). Questionnaires assessing somatic complaints (Beschwerdenliste, Zerssen, D. v., 1976. Die Beschwerden- Liste - Manual. Weinheim: Beltz Test GmbH) and Quality of Life (Quality of life questionnaire of the European foundation for osteoporosis 41; QUALEFFO 41) are handed out for completion on T 1, T2, T3, T4, T5 and days T1, T3, T5, respectively. |
| Secondary outcome measures | 1. Plasma levels of Osteocalcin (OC), Osteopontin (OPN), Leptin, Parathyroid Hormone (PTH) and Adrenocorticotropic Hormone (ACTH) 2. Somatic complaints and self-reported health. Questionnaires assessing somatic complaints (Beschwerdenliste, Zerssen, D. v., 1976. Die Beschwerden- Liste - Manual. Weinheim: Beltz Test GmbH) and Quality of Life (Quality of life questionnaire of the European foundation for osteoporosis 41; QUALEFFO 41) are handed out for completion on T 1, T2, T3, T4, T5 and days T1, T3, T5, respectively. |
| Overall study start date | 01/09/2010 |
| Completion date | 01/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | 1. Eligible participants are working females and males aged between 50 and 65. 2. Physical ability to meet the demands of the exercise program (i.e. at least 300 m of altitude difference per day) and sufficient knowledge of German to complete the questionnaires. |
| Key exclusion criteria | 1. Acute or chronic disturbances of the immune system 2. Hyperthyreosis 3. Cardiac arrhythmia 4. Renal insufficiency 5. Severe cardiovascular diseases 6. Acute infections or fever 7. Iritis 8. An acute attack of polyarthritis 9. Participants should not have used hormone replacement therapy or any other therapy affecting the bone metabolism during the last 12 months before enrollment. |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 01/09/2014 |
Locations
Countries of recruitment
- Austria
Study participating centre
5020
Austria
Sponsor information
Hospital/treatment centre
Gastein Research Institute
Strubergasse 21
Salzburg
5020
Austria
| Phone | +43 662 2420 80530 |
|---|---|
| martin.gaisbergerr@pmu.ac.at | |
"ROR" |
https://ror.org/03z3mg085 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | Yes | No |
Editorial Notes
02/11/2015: Publication reference added.
