Clinical trial NCT05155397: The Dortmund Vital Study: Impact of Biological and Lifestyle Factors on Cognitive Performace and Work Ability
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Age-related Cognitive Decline
Keywords: Cognitive Ageing
Occupational Health
Neuropsychology
Metabolism
Cardiovascular System
Behavioral Genetics
Immunology
EEG
MRI
psychoneuroendocrinology
Infectious diseases
Cognitive Neuroscience
Lead sponsor: Technical University of Dortmund
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 627
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals from the general population.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Dementia
* Parkinsonism
* Stroke
* 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

Primary outcomes:
measure: Change in performance on global cognitive composite score assessed by neuropsychological tests
timeFrame: Baseline and 5, 10, 15 years
measure: Change in attentional performance and perceptual control as assessed by a computerized Bar Task
timeFrame: Baseline and 5, 10, 15 years
measure: Change in vigilance control as assessed by a computerized Psychomotor Vigilance Test
timeFrame: Baseline and 5, 10, 15 years
measure: Change in stimulus-response compatibility and conflict processing assessed by the computerized Simon Task
timeFrame: Baseline and 5, 10, 15 years
measure: Change in updating and strategy learning assessed by the computerized AX-CPT Task
timeFrame: Baseline and 5, 10, 15 years
measure: Change in speech understanding and auditory distractibility assessed by computerized Speech-In-Noise perception task
timeFrame: Baseline and 5, 10, 15 years
measure: Change in working memory assessed by the computerized N-back Task
timeFrame: Baseline and 5, 10, 15 years
measure: Change in cue and memory-based task switching assessed by the computerized Task Switching Paradigm
timeFrame: Baseline and 5, 10, 15 years
measure: Change in auditive attention and distractibility assessed by the computerized Auditory Distraction Task
timeFrame: Baseline and 5, 10, 15 years
measure: Change in susceptibility to interference and the capacity to inhibit irrelevant stimuli assessed by the computerized Stroop Task
timeFrame: Baseline and 5, 10, 15 years
measure: Change in inhibitory control of prepotent responses assessed by the computerized Go/NoGo Task
timeFrame: Baseline and 5, 10, 15 years
measure: Change in spatial selective attention assessed by the computerized Visual Search Task
timeFrame: Baseline and 5, 10, 15 years
measure: Change in Work Ability Index
timeFrame: Baseline and 5, 10, 15 years
Secondary outcomes:
measure: Change in resting state EEG activity
timeFrame: baseline and 5, 10, 15 years
measure: Change in brain function MRI
timeFrame: 5, 10, 15 years
measure: Change in brain structure MRI
timeFrame: 5, 10, 15 years
measure: Change in Depressive Symptoms
timeFrame: Baseline and 5, 10, 15 years
measure: Change in Burnout Symptoms
timeFrame: Baseline and 5, 10, 15 years
measure: Change in Burnout Symptoms
timeFrame: Baseline and 5, 10, 15 years
measure: Change in Psychosocial Stress Symptoms
timeFrame: Baseline and 5, 10, 15 years
measure: Change in Chronic Stress Symptoms
timeFrame: Baseline and 5, 10, 15 years
measure: Change in Psychosocial Work Demands
timeFrame: 5, 10, 15 years
measure: Change in Self-Control at work
timeFrame: Baseline and 5, 10, 15 years
measure: Change in Cognitive Failures in the Daily Life
timeFrame: Baseline and 5, 10, 15 years
measure: Change in Positive and Negative Affect
timeFrame: Baseline and 5, 10, 15 years
measure: Change in Quality of Life
timeFrame: Baseline and 5, 10, 15 years
measure: Change in sociodemographic parameters
timeFrame: Baseline and 5, 10, 15 years
measure: Change in self-reported physical activity
timeFrame: Baseline and 5, 10, 15 years
measure: Change in lateralization and motor functions
timeFrame: Baseline and 5, 10, 15 years
measure: Change of cytokines concentration in serum
timeFrame: Baseline and 5, 10, 15 years
measure: Change of functional activiy of T cells and Natural Killer cells
timeFrame: Baseline and 5, 10, 15 years
measure: Change of peripheral blood mononuclear cells concentration
timeFrame: Baseline and 5, 10, 15 years
measure: Change in physical performance
timeFrame: Baseline and 5, 10, 15 years
measure: Change in cardiovascular parameters
timeFrame: Baseline and 5, 10, 15 years
measure: Change in electrocardiography
timeFrame: Baseline and 5, 10, 15 years
measure: Change in antibody concentrations of Toxoplasma gondii in serum
timeFrame: Baseline and 5, 10, 15 years
measure: Change in antibody concentrations of COVID-19 in serum
timeFrame: 5, 10, 15 years
measure: Change in metabolic parameters in blood
timeFrame: Baseline and 5, 10, 15 years
measure: Change of metabolic parameters in urine
timeFrame: Baseline and 5, 10, 15 years
measure: Change of endocrine parameter
timeFrame: Baseline and 5, 10, 15 years
Other outcomes:
measure: Genetic parameters (Single Nucleotide Polymorphisms; SNP)
timeFrame: Baseline
measure: Change in visual acuity
timeFrame: Baseline and 5, 10, 15 years
measure: Change in auditory acuity
timeFrame: Baseline and 5, 10, 15 years
measure: Change in Body Mass Index
timeFrame: Baseline and 5, 10, 15 years
measure: Change in Waist-To-Hip ratio
timeFrame: Baseline and 5, 10, 15 years
measure: Personality traits
timeFrame: Baseline
measure: Stress reactivity
timeFrame: Baseline
measure: Chronotype
timeFrame: Baseline
measure: Handedness
timeFrame: Baseline
measure: Traumatic Experiences During Childhood
timeFrame: Baseline
measure: Sociodemographic characteristics
timeFrame: Baseline
measure: Experiences with COVID-19 pandemic
timeFrame: 5, 10, 15 years
Locations:
city: Dortmund
country: Germany
facility: Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors
Study officials:
affiliation: Leibniz Research Centre for Working Environment and Human Factors at the TU Dortmund (IfADo)
name: Edmund Wascher, PhD
role: STUDY_DIRECTOR
References:
citation: Gajewski PD, Getzmann S, Brode P, Burke M, Cadenas C, Capellino S, Claus M, Genc E, Golka K, Hengstler JG, Kleinsorge T, Marchan R, Nitsche MA, Reinders J, van Thriel C, Watzl C, Wascher E. Impact of Biological and Lifestyle Factors on Cognitive Aging and Work Ability in the Dortmund Vital Study: Protocol of an Interdisciplinary, Cross-sectional, and Longitudinal Study. JMIR Res Protoc. 2022 Mar 14;11(3):e32352. doi: 10.2196/32352.
citation: Kleinert T, Nash K, Koenig T, Wascher E. Correction: Normative Intercorrelations between EEG Microstate Characteristics. Brain Topogr. 2024 Mar;37(2):270. doi: 10.1007/s10548-023-01012-4. No abstract available.
citation: Kleinert T, Nash K, Koenig T, Wascher E. Normative Intercorrelations Between EEG Microstate Characteristics. Brain Topogr. 2024 Mar;37(2):265-269. doi: 10.1007/s10548-023-00988-3. Epub 2023 Jul 14.
citation: Kleinert T, Koenig T, Nash K, Wascher E. On the Reliability of the EEG Microstate Approach. Brain Topogr. 2024 Mar;37(2):271-286. doi: 10.1007/s10548-023-00982-9. Epub 2023 Jul 6.
citation: Getzmann S, Arnau S, Gajewski PD, Wascher E. Auditory distraction, time perception, and the role of age: ERP evidence from a large cohort study. Neurobiol Aging. 2024 Dec;144:114-126. doi: 10.1016/j.neurobiolaging.2024.09.012. Epub 2024 Sep 20.
citation: Getzmann S, Gajewski PD, Schneider D, Wascher E. Resting-state EEG data before and after cognitive activity across the adult lifespan and a 5-year follow-up. Sci Data. 2024 Sep 10;11(1):988. doi: 10.1038/s41597-024-03797-w.
citation: Mundorf A, Getzmann S, Gajewski PD, Larra MF, Wascher E, Genc E, Ocklenburg S. Phenotyping in clinical laterality research: a comparison of commonly used methods to determine mixed-handedness and ambidexterity. Laterality. 2024 May;29(3):331-349. doi: 10.1080/1357650X.2024.2370871. Epub 2024 Jul 5.
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citation: Brode P, Claus M, Gajewski PD, Getzmann S, Wascher E, Watzl C. From Immunosenescence to Aging Types-Establishing Reference Intervals for Immune Age Biomarkers by Centile Estimation. Int J Mol Sci. 2023 Aug 24;24(17):13186. doi: 10.3390/ijms241713186.
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citation: Metzen D, Genc E, Getzmann S, Larra MF, Wascher E, Ocklenburg S. Frontal and parietal EEG alpha asymmetry: a large-scale investigation of short-term reliability on distinct EEG systems. Brain Struct Funct. 2022 Mar;227(2):725-740. doi: 10.1007/s00429-021-02399-1. Epub 2021 Oct 21.
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citation: Gajewski PD, Hanisch E, Falkenstein M, Thones S, Wascher E. What Does the n-Back Task Measure as We Get Older? Relations Between Working-Memory Measures and Other Cognitive Functions Across the Lifespan. Front Psychol. 2018 Nov 26;9:2208. doi: 10.3389/fpsyg.2018.02208. eCollection 2018.
citation: Brode P, Claus M, Gajewski PD, Getzmann S, Golka K, Hengstler JG, Wascher E, Watzl C. Calibrating a Comprehensive Immune Age Metric to Analyze the Cross Sectional Age-Related Decline in Cardiorespiratory Fitness. Biology (Basel). 2022 Oct 27;11(11):1576. doi: 10.3390/biology11111576.
citation: Mundorf A, Getzmann S, Gajewski PD, Larra MF, Wascher E, Ocklenburg S. Stress exposure, hand preference, and hand skill: A deep phenotyping approach. Laterality. 2023 Mar-May;28(2-3):209-237. doi: 10.1080/1357650X.2023.2204551. Epub 2023 Apr 26.
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