Trial Outcomes & Findings for Cognitive Function in Elderly Marathon Runners (NCT NCT01045031)

Results Overview

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

Recruitment status

UNKNOWN

Target enrollment

114 participants

Primary outcome timeframe

10 years

Results posted on

2018-06-26

Participant Flow

Of 136 initially screened individuals (63 athletes, 73 controls), a total of 114 subjects could be enrolled since they met all inclusion criteria.

Participant milestones

Participant milestones
Measure	Controls The control group was matched according to age, sex and years of education.	Marathon Athletes Runners and bicyclists 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) were recruited. The inclusion criteria were (1) participation in at least one of these 3 marathons in the preceding two years, (2) were still in continuous training during the recruitment phase (at least 2 hours/week) and (3) were over the age of 60.
Overall Study STARTED	58	56
Overall Study COMPLETED	49	50
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Function in Elderly Marathon Runners

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Marathon Athletes n=56 Participants Participation in more than one of the following competitions during the previous three years: Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km)	Controls n=58 Participants The control group was matched according to age, sex and years of education.	Total n=114 Participants Total of all reporting groups
Age, Continuous	66.0 years STANDARD_DEVIATION 4.7 • n=99 Participants	65.9 years STANDARD_DEVIATION 4.1 • n=107 Participants	65.9 years STANDARD_DEVIATION 4.4 • n=206 Participants
Sex: Female, Male Female	6 Participants n=99 Participants	6 Participants n=107 Participants	12 Participants n=206 Participants
Sex: Female, Male Male	50 Participants n=99 Participants	52 Participants n=107 Participants	102 Participants n=206 Participants

PRIMARY outcome

Timeframe: 10 years

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and 5 years

Population: Baseline values differ from published data, since BDNF-levels had to be re-assessed from banked material due to a manufacturer-based change of the analysis kit.

Outcome measures

Outcome measures
Measure	Marathon Athletes n=50 Participants Brain-derived Neurotrophic Factor (BDNF)	Controls n=49 Participants Brain-derived Neurotrophic Factor (BDNF)
Brain-derived Neurotrophic Factor (BDNF) Baseline	310 ng/mL Standard Deviation 137	323 ng/mL Standard Deviation 157
Brain-derived Neurotrophic Factor (BDNF) Follow-up	419 ng/mL Standard Deviation 117	500 ng/mL Standard Deviation 148

SECONDARY outcome

Timeframe: Baseline and 5 years

Population: Study population (Baseline and follow-up)

The following self rating scales were used: WHO-5 Quality of Life Assessment (Braeher, E., Muehlan, H., Albani, C., \& Schmidt, S. (2007). Testing and standardization of the German version of the EUROHIS-QOL and WHO-5 quality-of life-indices. Diagnostica, 53(2), 83-96.). Range: 0 - 25, higher scores indicate better quality of life.

Outcome measures

Outcome measures
Measure	Marathon Athletes n=49 Participants Brain-derived Neurotrophic Factor (BDNF)	Controls n=50 Participants Brain-derived Neurotrophic Factor (BDNF)
Self Rating by Questionnaires Baseline	17.8 point scale Standard Deviation 4.2	19.9 point scale Standard Deviation 2.8
Self Rating by Questionnaires Follow-up	17.6 point scale Standard Deviation 5.4	20.3 point scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline and 5 years

Outcome measures

Outcome measures
Measure	Marathon Athletes n=49 Participants Brain-derived Neurotrophic Factor (BDNF)	Controls n=50 Participants Brain-derived Neurotrophic Factor (BDNF)
Insulin-like Growth Factor (IGF-1) Baseline	137.7 ng/mL Standard Deviation 41.1	137.4 ng/mL Standard Deviation 39.7
Insulin-like Growth Factor (IGF-1) Follow-up	155.2 ng/mL Standard Deviation 40.5	156.7 ng/mL Standard Deviation 39.9

Adverse Events

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Athletes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Winker

Health and Prevention Center, Sanatorium Hera, Vienna, Austria

Phone: 0043(1)-31350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place