- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02082106
Metabolic and Physiological Stress During Skiing.
Metabolic and Physiological Stress During Alpine Skiing, Cross-country Skiing and Indoor Training in Untrained and Trained Persons.
Problem description In industrialized countries there is a rapid increase in the number of senior citizens. In Austria more than 50% of the population is overweight, with highest prevalence in the age group from 60 to 74 yrs and the WHO lists physical inactivity as one of the main behavioral risk factors of cardiovascular diseases.
Especially in winter months, activity related energy expenditure was 40% and 31% lower in the US and Canada, respectively. In addition, in an Austrian study the winter season was associated with higher blood pressure, total cholesterol and body mass index, giving an increasing risk of chronic coronary disease by 6.8% in men and 3.6% in women.
Therefore, the development of intervention programs that overcome the winter physical activity deficit and be feasible also for elderly should be goal of future research. Alpine skiing (AS) and cross country skiing (XCS) have a long standing tradition in Austria and could potentially fill the winter physical activity gap. The Salzburg Skiing for the Elderly Study (SASES) has found AS to be a save and feasible possibility to improve the health of the aged population in many parameters. XCS as a competitive sport is already well explored but there are hardly any studies about its effects in the normal or elderly population. Unfortunately knowledge about the differences between AS and XCS in the physiological adaptation processes in the elderly population is also lacking.
Aims and hypotheses of the pre-study In order to standardize training interventions, the present pre-study aims at comparing physiological and metabolic parameters between AS, XCS and IT. Therefore, the results of the pre-study serve as determinants for the training parameters of the above mentioned main study.
We postulate that, based on the results of the present study, it is possible to set up comparable isocaloric training sessions for AS, XCS and IT for elderly and unfit persons.
Furthermore, we assume that elderly and unfit subjects are able to perform a full spectrum of intensities and techniques necessary to set appropriate stimuli for isocaloric comparison.
We hypothesize arterial stiffness indices and circulating microRNA (miRNA) patterns to change due to one bout of physical activity of AS, XCS, and IT with variations depending on the kind of sport.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Salzburg, Austria, A-5020
- University Institute of Sports Medicine, Prevention and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- written informed consent
- male or female
- age: 30+ years
- inconspicuous ECG
- Non-smoker for at least one year
- proper skills in alpine skiing and cross-country skiing
Exclusion Criteria:
- Participation in other clinical trials at the same time or within the previous 6 months
- Tiffeneau-Pinelli index: Forced Expiratory Volume in first second (FEV1) / Forced Vital Capacity (FVC) <60% with/without symptoms (coughing, sputum) or other evidence of a pulmonary disease
- medical condition which conflicts with participation in training
- Intake of anticoagulants
- Alcohol or drug abuse
- Severe obesity: BMI >40
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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males/females
Participants should be capable of alpine skiing and cross country skiing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Oxygen consumption (VO2)
Time Frame: 12 weeks
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VO2 will be measured during during physical examination, indoor training, Alpine Skiing, and Cross Country Skiing.
VO2 will be transformed into metabolic equivalents to calculate isocaloric training parameters for the different kind of sport.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pulse wave analysis (PWA)
Time Frame: 12 weeks
|
PWA will be measured before/after physical examination, indoor training, Alpine Skiing, and Cross Country Skiing.
PWA will be done by oscillometric measurement to calculate influence of acute exercise and training status on several pulse wave parameters.
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12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RNA
Time Frame: 12 weeks
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Total RNA will be isolated from stored plasma and blood cell samples.
All samples will be screened for influence of acute exercise (before/after physical examination and indoor training).
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12 weeks
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Nitric oxide (NO)
Time Frame: 12 weeks
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NO will be quantified out of stored blood samples and serves as a possible surrogate parameter of pulse wave analysis.
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12 weeks
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Metabolic screening
Time Frame: 12 weeks
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Metabolic parameters (e.g.
glucose, lactate) will be quantified out of stored blood samples: These parameters serve as determinants of the different exercises.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Josef Niebauer, MBA, Prof. Dr.Dr., Paracelsus Medical University
- Study Chair: Martin Schoenfelder, Dr., Research Institute of Moleclar Sport and Rehabilitation Medicine, Paracelsus Medical University Salzburg, Austria
- Study Chair: Thomas Stoeggl, Prof. Dr., Department of Sport Sciency and Kinesiology - University of Salzburg
Publications and helpful links
General Publications
- Muller E, Gimpl M, Poetzelsberger B, Finkenzeller T, Scheiber P. Salzburg Skiing for the Elderly Study: study design and intervention--health benefit of alpine skiing for elderly. Scand J Med Sci Sports. 2011 Aug;21 Suppl 1:1-8. doi: 10.1111/j.1600-0838.2011.01336.x.
- Niederseer D, Ledl-Kurkowski E, Kvita K, Patsch W, Dela F, Mueller E, Niebauer J. Salzburg Skiing for the Elderly Study: changes in cardiovascular risk factors through skiing in the elderly. Scand J Med Sci Sports. 2011 Aug;21 Suppl 1:47-55. doi: 10.1111/j.1600-0838.2011.01341.x.
- Muller E, Gimpl M, Kirchner S, Kroll J, Jahnel R, Niebauer J, Niederseer D, Scheiber P. Salzburg Skiing for the Elderly Study: influence of alpine skiing on aerobic capacity, strength, power, and balance. Scand J Med Sci Sports. 2011 Aug;21 Suppl 1:9-22. doi: 10.1111/j.1600-0838.2011.01337.x.
- Finkenzeller T, Muller E, Wurth S, Amesberger G. Does a skiing intervention influence the psycho-social characteristics of the elderly? Scand J Med Sci Sports. 2011 Aug;21 Suppl 1:69-75. doi: 10.1111/j.1600-0838.2011.01344.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UISM-2014-MET-SKI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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