NCT02082106

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

February 11, 2014

Last Update Submit

April 28, 2015

Conditions

Keywords

alpine skiingcross country skiingindoor cyclingphysical fitnesstraining statusmetabolic equivalent

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (1)

  • Pulse wave analysis (PWA)

    12 weeks

Other Outcomes (3)

  • RNA

    12 weeks

  • Nitric oxide (NO)

    12 weeks

  • Metabolic screening

    12 weeks

Study Arms (1)

males/females

Participants should be capable of alpine skiing and cross country skiing.

Other: Alpine skiingOther: cross country skiingOther: Indoor training (cycling)

Interventions

males/females
males/females
males/females

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty healthy subjects (male=10/female=10) aged 30+ will be recruited.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Institute of Sports Medicine, Prevention and Rehabilitation

Salzburg, A-5020, Austria

Location

Related Publications (4)

  • 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.

    PMID: 21679318BACKGROUND
  • 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.

    PMID: 21679323BACKGROUND
  • 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.

    PMID: 21679319BACKGROUND
  • 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.

    PMID: 21679326BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum, blood plasma, blood cells

Study Officials

  • Josef Niebauer, MBA, Prof. Dr.Dr.

    Paracelsus Medical University

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Institute; University Institute of Sports Medicine, Prevention and Rehabilitation

Study Record Dates

First Submitted

February 11, 2014

First Posted

March 10, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations