HealthyNCT02082106
Metabolic and Physiological Stress During Skiing.
An observational study of Healthy, run by Paracelsus Medical University at 1 site in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Alpine skiing, cross country skiing and Indoor training (cycling)
- How many people
- 21 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2014to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty healthy subjects (male=10/female=10) aged 30+ will be recruited.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
University Institute of Sports Medicine, Prevention and Rehabilitation
Salzburg, A-5020
About this study
Official title: 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.
Read more
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.
- Conditions
- Healthy
- Being tested
- Alpine skiing, cross country skiing, Indoor training (cycling)
- Keywords
- alpine skiing, cross country skiing, indoor cycling, physical fitness, training status, metabolic equivalent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpine skiingOther
cross country skiingOther
Indoor training (cycling)Other
| Study group | Role | What they receive |
|---|---|---|
| males/females | Participants should be capable of alpine skiing and cross country skiing. Receives: Other: Alpine skiing; Other: cross country skiing; Other: Indoor training (cycling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption (VO2)
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.
Measured: 12 weeks
Secondary outcomes (1)
Pulse wave analysis (PWA)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
- Investigators
- Josef Niebauer, MBA, Prof. Dr.Dr., Principal investigator, Paracelsus Medical UniversityMartin Schoenfelder, Dr., Study chair, Research Institute of Moleclar Sport and Rehabilitation Medicine, Paracelsus Medical University Salzburg, AustriaThomas Stoeggl, Prof. Dr., Study chair, Department of Sport Sciency and Kinesiology - University of Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082106
- Sponsor's protocol ID
- UISM-2014-MET-SKI
- Status last verified
- Apr 2015
- First submitted
- 11 Feb 2014
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21679318Niederseer 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.
PubMed 21679323Muller 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.
PubMed 21679319Finkenzeller 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.
PubMed 21679326
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Physiological Stress During Alpine Skiing, Cross-country Skiing and Indoor Training in Untrained and Trained Persons.
- ClinicalTrials.gov ID
- NCT02082106
- Acronym / sponsor ID
- UISM-2014-MET-SKI
- Conditions
- Healthy
- Keywords
- alpine skiing, cross country skiing, indoor cycling, physical fitness, training status, metabolic equivalent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| males/females | – | Other: Alpine skiing, Other: cross country skiing, Other: Indoor training (cycling)Participants should be capable of alpine skiing and cross country skiing. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty healthy subjects (male=10/female=10) aged 30+ will be recruited.
Key inclusion criteria (6 listed)
- written informed consent
- male or female
- age: 30+ years
- inconspicuous ECG
- Non-smoker for at least one year
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpine skiing | Other | males/females |
| cross country skiing | Other | males/females |
| Indoor training (cycling) | Other | males/females |
Primary outcome
Oxygen consumption (VO2)
Time frame: 12 weeks
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.
1 secondary outcome
Pulse wave analysis (PWA)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Background: PubMed 21679318Muller 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.
- Background: PubMed 21679323Niederseer 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.
- Background: PubMed 21679319Muller 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.
- Background: PubMed 21679326Finkenzeller 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.
- Research Institute of Molecular Sport and Rehabilitation MedicineLink provided by the sponsor.
- University Institute of Sports Medicine, Prevention and RehabilitationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Niebauer, MBA, Prof. Dr.Dr. principal investigator
Paracelsus Medical University
Martin Schoenfelder, Dr. study chair
Research Institute of Moleclar Sport and Rehabilitation Medicine, Paracelsus Medical University Salzburg, Austria
Thomas Stoeggl, Prof. Dr. study chair
Department of Sport Sciency and Kinesiology - University of Salzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Paracelsus Medical University at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption (VO2) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02082106, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.