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临床试验/NCT05155397
NCT05155397进行中(未招募)不适用

The Dortmund Vital Study: Impact of Biological and Lifestyle Factors on Cognitive Performace and Work Ability Across the Lifespan. An Interdisciplinary, Cross-sectional and Longitudinal Study

Technical University of Dortmund1 个研究点 分布在 1 个国家目标入组 627 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
627
试验地点
1
主要终点
Change in vigilance control as assessed by a computerized Psychomotor Vigilance Test

研究概览

简要总结

The goal of the Dortmund Vital Study is to validate previous hypotheses and to generate and validate new hypotheses about the relationship of ageing, working conditions, genetic makeup, stress, metabolic functions, cardiovascular system, immune system, and mental performance over the lifespan with a focus on healthy working adults. The Dortmund Vital Study is a multidisciplinary longitudinal study involving the Departments of Ergonomics, Immunology, Psychology and Neurosciences, and Toxicology of the Leibniz Research Centre for Working Environment and Human Factors at the TU Dortmund (IfADo) in Dortmund, Germany, as well as several national and international cooperation partners.

详细描述

The Dortmund Vital Study is designed as a combined cross-sectional and longitudinal study. About 600 subjects aged between 20 and 70 years will participate. A wide range of demographic, psychological, behavioral, sensory, cardiovascular, biochemical, immunological and biochemical data, a comprehensive EEG-based cognitive test battery as well as structural and functional magnetic resonance imaging (MRI) have been included in the study. Specifically, parameters obtained by MRI and EEG-related measures can be evaluated as a function of polygenic scores, metabolic products, concentration of immune cells, immune age and infections, such as Toxoplasmosis or COVID-19 that are largely unexplored. The same is true for environmental and lifestyle factors that impact on brain activity and behavior.

The initial testing has been conducted between 2016 and 2021 and will be repeated every five years (three follow-up measures until 2035).

The study will shed light on sources of large inter-individual differences in cognitive functioning with increasing age and reveal biological and lifestyle markers contributing to work ability, longevity and healthy aging on the one hand, and on risk factors for cognitive decline, mild cognitive impairment or even dementia on the other.

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
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Blood thinners
  • •Antihypertensives
  • •Cholesterol reducers
  • •Normal or corrected-to-normal vision and hearing
  • •Fulfill standard inclusion criteria for MRI measurements
  • •Sufficient language skills

排除标准

  • •Parkinsonism
  • •Cardiovascular diseases
  • •Bleeding tendency
  • •Oncological diseases
  • •Schizophrenia
  • •Obsessive-compulsive disorder
  • •Anxiety disorders
  • •Severe depression
  • •Head injuries
  • •Head surgery
  • •Head implants
  • •Eye diseases (cataract, glaucoma, blindness)
  • •Accidents that limit physical fitness and mobility
  • •Psychotropic drugs
  • •Neuroleptics

结局指标

主要结局

Change in vigilance control as assessed by a computerized Psychomotor Vigilance Test

时间窗: Baseline and 5, 10, 15 years

Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in a Psychomotor Vigilance Test.

Change in speech understanding and auditory distractibility assessed by computerized Speech-In-Noise perception task

时间窗: Baseline and 5, 10, 15 years

Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Speech-in-noise perception task.

Change in stimulus-response compatibility and conflict processing assessed by the computerized Simon Task

时间窗: Baseline and 5, 10, 15 years

Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Simon task.

Change in auditive attention and distractibility assessed by the computerized Auditory Distraction Task

时间窗: Baseline and 5, 10, 15 years

Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Auditory Distraction Task.

Change in attentional performance and perceptual control as assessed by a computerized Bar Task

时间窗: Baseline and 5, 10, 15 years

Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in attentional performance and perceptual control assessed by the Bar Task.

Change in working memory assessed by the computerized N-back Task

时间窗: Baseline and 5, 10, 15 years

Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the N-back task.

Change in cue and memory-based task switching assessed by the computerized Task Switching Paradigm

时间窗: Baseline and 5, 10, 15 years

Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the cue- and memory based task switching.

Change in susceptibility to interference and the capacity to inhibit irrelevant stimuli assessed by the computerized Stroop Task

时间窗: Baseline and 5, 10, 15 years

Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Stroop Task.

Change in inhibitory control of prepotent responses assessed by the computerized Go/NoGo Task

时间窗: Baseline and 5, 10, 15 years

Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Go/NoGo Task.

Change in Work Ability Index

时间窗: Baseline and 5, 10, 15 years

Change in work ability assessed by Work Ability Index (WAI). WAI assess physical and psychological risks to avoid work-related disabilities and early retirement. The index is determined by the employees' answers related to work demands, individual health status and physical and psychological capacities. The total score of WAI is calculated by summing up scores of seven dimensions. The work ability ranged between 7 (insufficient) and 49 points (best work ability).

Change in performance on global cognitive composite score assessed by neuropsychological tests

时间窗: Baseline and 5, 10, 15 years

Change in performance on global cognitive composite score based on measures from neuropsychological tests: Digit-Span forward and backward, semantic memory in written and spoken versions (Word-Fluency), selective attention and attentional endurance (D2-R), crystallized intelligence (Multiple Choice Vocabulary Test), general cognitive status (Mini-Mental-State-Examination; MMSE), different aspects of verbal memory like learning performance and retrieval (Verbal Learning and Memory Tests; VLMT), psychomotor performance and speed of processing (Digit-Symbol-Test), interference control and inhibition (Stroop Test), task switching (Trail-Making-Test; TMT-A and TMT-B), two subtests from the performance testing system measuring logical reasoning and spatial rotation, and fluid intelligence assessed by Raven's Progressive Matrices.

Change in updating and strategy learning assessed by the computerized AX-CPT Task

时间窗: Baseline and 5, 10, 15 years

Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the AX-CPT task.

Change in spatial selective attention assessed by the computerized Visual Search Task

时间窗: Baseline and 5, 10, 15 years

Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Visual Search Task.

次要结局

  • Change in Quality of Life(Baseline and 5, 10, 15 years)
  • Change in resting state EEG activity(baseline and 5, 10, 15 years)
  • Change in brain function MRI(5, 10, 15 years)
  • Change in brain structure MRI(5, 10, 15 years)
  • Change in Depressive Symptoms(Baseline and 5, 10, 15 years)
  • Change in Burnout Symptoms(Baseline and 5, 10, 15 years)
  • Change in Psychosocial Stress Symptoms(Baseline and 5, 10, 15 years)
  • Change in Chronic Stress Symptoms(Baseline and 5, 10, 15 years)
  • Change in Psychosocial Work Demands(5, 10, 15 years)
  • Change in Self-Control at work(Baseline and 5, 10, 15 years)
  • Change in Cognitive Failures in the Daily Life(Baseline and 5, 10, 15 years)
  • Change in Positive and Negative Affect(Baseline and 5, 10, 15 years)
  • Change in sociodemographic parameters(Baseline and 5, 10, 15 years)
  • Change in self-reported physical activity(Baseline and 5, 10, 15 years)
  • Change in lateralization and motor functions(Baseline and 5, 10, 15 years)
  • Change of cytokines concentration in serum(Baseline and 5, 10, 15 years)
  • Change of functional activiy of T cells and Natural Killer cells(Baseline and 5, 10, 15 years)
  • Change of peripheral blood mononuclear cells concentration(Baseline and 5, 10, 15 years)
  • Change in physical performance(Baseline and 5, 10, 15 years)
  • Change in cardiovascular parameters(Baseline and 5, 10, 15 years)
  • Change in electrocardiography(Baseline and 5, 10, 15 years)
  • Change in antibody concentrations of Toxoplasma gondii in serum(Baseline and 5, 10, 15 years)
  • Change in antibody concentrations of COVID-19 in serum(5, 10, 15 years)
  • Change in metabolic parameters in blood(Baseline and 5, 10, 15 years)
  • Change of metabolic parameters in urine(Baseline and 5, 10, 15 years)
  • Change of endocrine parameter(Baseline and 5, 10, 15 years)

研究者

发起方
Technical University of Dortmund
申办方类型
Other
责任方
Sponsor

研究点 (1)

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