NCT01045031

Brief Summary

There is substantial research on the effects of physical exercise on cognitive functions. However, less attention has been paid on the requirements of training intensity and length to enhance cognitive abilities in the elderly. To the investigators knowledge no studies have evaluated the effects of extensive endurance exercise training on cognitive functions by studying elderly marathon runners and bicyclists. On the basis of the scientific literature published so far it is not known whether the beneficial impact of endurance exercise training depends on the intensity of training. The investigators therefore designed a cohort study with adequate power in order to evaluate the effects of intensive endurance exercise training on cognition. This trial, an Austrian prospective cohort study in cognitive function of elderly marathon-runners (APSOEM) is being conducted and will compare neuropsychological performance outcomes of elderly marathon runners or bicyclists with controls matched concerning age, education years, occupation, and verbal intelligence.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Status
unknown

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

December 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 11, 2016

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 26, 2018

Status Verified

March 1, 2018

Enrollment Period

5.2 years

First QC Date

January 7, 2010

Results QC Date

March 15, 2016

Last Update Submit

March 27, 2018

Conditions

Keywords

cognitive function, aging, brain-derived neurotrophic factor

Outcome Measures

Primary Outcomes (2)

  • the Proportion of Subjects, Who Will Develop Mild Cognitive Impairment

    Hypothesis will be tested at the second follow-up examinations.

    10 years

  • Brain-derived Neurotrophic Factor (BDNF)

    Baseline and 5 years

Secondary Outcomes (2)

  • Self Rating by Questionnaires

    Baseline and 5 years

  • Insulin-like Growth Factor (IGF-1)

    Baseline and 5 years

Study Arms (2)

Controls

Controls were subsequently contacted via personal contact and three additional advertisements (two in an Austrian newspaper ("Krone") and one in an Austrian bicyclist journal ("Bicyclist Sports"). The controls were matched according to age, sex and years of education

marathon athletes

Runners participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km). Inclusion criteria:1) participation in at least one of these 3 marathons in the preceding two years,2)still in continuous training during the recruitment phase (at least 2 hours/week), 3) aged over 60. Exclusion criteria:(a) present or past exposure to neurotoxic substances (b) if they did not speak German as their native language (c) diseases that markedly affect CNS functions (d) manifest cardiovascular disease, (e) chronic alcoholism (daily alcohol intake \> 60 g or diagnosed history of alcoholism) and (f) unwillingness to give informed consent.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Marathon runners, bicyclists and controls from the greater Vienna area

You may qualify if:

  • Current Marathon runners or marathon bicyclists and controls from the greater Vienna area

You may not qualify if:

  • Current of past neurotoxic exposure
  • Not German as native language
  • Diseases, that might affect central nervous system (stroke, meningitis, meningeoma, hydrocephalus,..)
  • Manifest cardiovascular disease
  • Alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Mucher P, Batmyagmar D, Perkmann T, Repl M, Radakovics A, Ponocny-Seliger E, Lukas I, Fritzer-Szekeres M, Lehrner J, Knogler T, Tscholakoff D, Fondi M, Wagner OF, Winker R, Haslacher H. Basal myokine levels are associated with quality of life and depressed mood in older adults. Psychophysiology. 2021 May;58(5):e13799. doi: 10.1111/psyp.13799. Epub 2021 Mar 2.

  • Winker R, Lukas I, Perkmann T, Haslacher H, Ponocny E, Lehrner J, Tscholakoff D, Dal-Bianco P. Cognitive function in elderly marathon runners: cross-sectional data from the marathon trial (APSOEM). Wien Klin Wochenschr. 2010 Dec;122(23-24):704-16. doi: 10.1007/s00508-010-1485-z. Epub 2010 Nov 15.

Biospecimen

Retention: SAMPLES WITH DNA

Apolipoprotein E4 genotype, Insulin-like growth factor-1, Brain-derived neurotrophic factor, rs6265-Genotype

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Robert Winker
Organization
Health and Prevention Center, Sanatorium Hera, Vienna, Austria

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 8, 2010

Study Start

December 1, 2008

Primary Completion

February 1, 2014

Study Completion

December 1, 2018

Last Updated

June 26, 2018

Results First Posted

July 11, 2016

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share