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临床试验/NCT01045031
NCT01045031Unknown不适用

Austrian Prospective Cohort Study in Cognitive Function of Elderly Marathon-runners

Medical University of Vienna0 个研究点目标入组 114 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
114
主要终点
the Proportion of Subjects, Who Will Develop Mild Cognitive Impairment

研究概览

简要总结

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.

详细描述

Design of the trial The data reported in this study are derived from the cognitive testing and determination of humoral growth factors at the time of the survey 1 (recruitment phase). To determine whether extensive endurance training enhances cognitive abilities in the elderly, we plan to compare longitudinally the outcomes of various neuropsychological tests and humoral markers in elderly marathon runners or bicyclists with controls matched for age, sex, and years of education at the time of the survey 2 (5-year follow-up) and at the time of the survey 3 (10-year follow-up). 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) were recruited with the assistance of the organizers and via personal contacts. Runners or bicyclists were eligible for inclusion in the study if (a) they had participated in at least one of these 3 marathons in the preceding two years, (b) were still in continuous training during the recruitment phase (at least 2 hours/week) and (c) were over the age of 60. Exclusion criteria were (a) present or past exposure to neurotoxic substances (b) if they did not speak German as their native language (verbal intelligence) (c) diseases that markedly affect CNS functions: for example, cerebrovascular stroke, brain tumor, depression, Alzheimer's disease, epilepsy, multiple sclerosis, Parkinson's disease, etc. (d) manifest cardiovascular disease, (e) chronic alcoholism (daily alcohol intake > 60 g or diagnosed history of alcoholism) and (f) unwillingness to give informed consent. 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. Detailed information about education, smoking habits, family history, exercise training and medication was obtained. All participants had an extensive medical evaluation carried out by an experienced internal specialist including blood withdrawal when entering the study. Since it has been shown that humoral growth factor levels can vary with the circadian rhythm , all examinations were started between 10 am and 10.30 am. In cases where the examination revealed neurological abnormalities, participants were additionally examined by a neurologist. Besides the physical examination with blood withdrawal described above, the study protocol included an ergometry, neuropsychological testing, the use of a set of questionnaires and magnetic resonance imaging. All participants underwent the study protocol tests in the above-mentioned same chronological order.

The study was approved by the ethics committee of the medical faculty of the University of Vienna (number EK 401/2005). All subjects gave written informed consent before entering the study. Procedures followed were in accordance with institutional guidelines.

Ergometry Individual working capacity was calculated as a percentage of the predicted (=100% work load) Watt value (derived from the tabulation, standardized for sex, age, and body surface [28]). Briefly, the workload was increased every two minutes in steps of 25 W, beginning with 25 W and going on until the point of exhaustion (Ergoline, Ergometrics 900). The individual physical working capacity (PWC) was expressed as the individual maximal power (Watt)max in percent of a reference value (Wattref): PWCind = 100 x Wattmax/Wattref [28].

Neuropsychological testing and questionnaires The Vienna Neuropsychological Test Battery (VNTB)as well as the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) were selected in order to assess cognitive functions, such as visuo-construction, concentration/attention, language, memory and executive functioning domains. These cognitive abilities are known to be commonly affected by Alzheimer's disease and other dementias. The two batteries of tests have been found to be sensitive in the evaluation of mild cognitive impairment.

Each test run began with a screening of global cognitive functions via the Mini Mental State Examination (MMSE) and the Clock Drawing Test. Thereafter participants were subjected to a cognitive testing assessing visuo-constructional abilities, attention, language functions, memory and executive functions. Details of cognitive testing are described in the Appendix.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

the Proportion of Subjects, Who Will Develop Mild Cognitive Impairment

时间窗: 10 years

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

Brain-derived Neurotrophic Factor (BDNF)

时间窗: Baseline and 5 years

次要结局

  • Self Rating by Questionnaires(Baseline and 5 years)
  • Insulin-like Growth Factor (IGF-1)(Baseline and 5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Winker

Ass. Prof.

Medical University of Vienna

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