The Dortmund Vital Study: Impact of Biological and Lifestyle Factors on Cognitive Performace and Work Ability

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Age-related Cognitive Decline

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in performance on global cognitive composite score assessed by neuropsychological tests | 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. | Baseline and 5, 10, 15 years | 
| Change in attentional performance and perceptual control as assessed by a computerized Bar Task | Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in attentional performance and perceptual control assessed by the Bar Task. | Baseline and 5, 10, 15 years | 
| Change in vigilance control as assessed by a computerized Psychomotor Vigilance Test | Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in a Psychomotor Vigilance Test. | Baseline and 5, 10, 15 years | 
| Change in stimulus-response compatibility and conflict processing assessed by the computerized Simon Task | Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Simon task. | Baseline and 5, 10, 15 years | 
| Change in updating and strategy learning assessed by the computerized AX-CPT Task | Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the AX-CPT task. | Baseline and 5, 10, 15 years | 
| Change in speech understanding and auditory distractibility assessed by computerized Speech-In-Noise perception task | Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Speech-in-noise perception task. | Baseline and 5, 10, 15 years | 
| Change in working memory assessed by the computerized N-back Task | Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the N-back task. | Baseline and 5, 10, 15 years | 
| Change in cue and memory-based task switching assessed by the computerized Task Switching Paradigm | Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the cue- and memory based task switching. | Baseline and 5, 10, 15 years | 
| Change in auditive attention and distractibility assessed by the computerized Auditory Distraction Task | Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Auditory Distraction Task. | Baseline and 5, 10, 15 years | 
| Change in susceptibility to interference and the capacity to inhibit irrelevant stimuli assessed by the computerized Stroop Task | Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Stroop Task. | Baseline and 5, 10, 15 years | 
| Change in inhibitory control of prepotent responses assessed by the computerized Go/NoGo Task | Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Go/NoGo Task. | Baseline and 5, 10, 15 years | 
| Change in spatial selective attention assessed by the computerized Visual Search Task | Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Visual Search Task. | Baseline and 5, 10, 15 years | 
| Change in Work Ability Index | 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). | Baseline and 5, 10, 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in resting state EEG activity | Change in resting state EEG activity measured for 2 minutes with eyes open, and 2 minutes with eyes closed. | baseline and 5, 10, 15 years | 
| Change in brain function MRI | Changes in functional magnetic resonance imaging assessed by resting state MRI. | 5, 10, 15 years | 
| Change in brain structure MRI | Changes in structural resonance imaging assessed by multi-shell diffusion-weighted imaging (DWI). | 5, 10, 15 years | 
| Change in Depressive Symptoms | Change in total score using the Becks Depression Inventory (BDI). | Baseline and 5, 10, 15 years | 
| Change in Burnout Symptoms | Change in total score using the Maslach Burnout Inventory (MBI-GS). | Baseline and 5, 10, 15 years | 
| Change in Psychosocial Stress Symptoms | Change in total score using the Psychosocial Stress Questionnaire (PSQ-20). | Baseline and 5, 10, 15 years | 
| Change in Chronic Stress Symptoms | Change in chronic stress symptoms assessed by the Trier Inventory of Chronic Stress (TICS), consisting of several dimensions: Work Overload, Social Overload, Pressure to Perform, Work Discontent, Demands from work, Lack of Social Recognition, Social Tensions, Social Isolation, Chronic Worrying, and a 12 Item Screening-Scale (SSCS) that provides a score for general stress. | Baseline and 5, 10, 15 years | 
| Change in Psychosocial Work Demands | Change in total score in the Copenhagen Psychosocial Questionnaire (COPSOQ III) that consists of several dimensions: cognitive and physical demands at work, job control, influence at work, developmental possibilities, interpersonal relations, leadership, and strain. | 5, 10, 15 years | 
| Change in Self-Control at work | Change of the psychosocial demands at work assessed by the scale Self-Control at Work. | Baseline and 5, 10, 15 years | 
| Change in Cognitive Failures in the Daily Life | Change in cognitive failures in daily life assessed by the Cognitive Failure Questionnaire (CFQ). | Baseline and 5, 10, 15 years | 
| Change in Positive and Negative Affect | Change in scores of positive and negative affect. The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. | Baseline and 5, 10, 15 years | 
| Change in Quality of Life | Change in total score of the quality of life questionnaire (WHOQoL-BREF), consisting of dimensions: physical, psychological, social, environmental, and global quality of life. | Baseline and 5, 10, 15 years | 
| Change in sociodemographic parameters | Change in different sociodemographic aspects like marital status, occupational status, nutrition, leisure activities, alcohol drinking, frequency of social contacts, using of electronic media etc. Qualitative data will be categorized. | Baseline and 5, 10, 15 years | 
| Change in self-reported physical activity | Change of the self-reported physical activity (Lüdenscheid Physical Activity Questionnaire) in minutes per week. | Baseline and 5, 10, 15 years | 
| Change in lateralization and motor functions | Change in total score of the Perdue Pegboard Test, assessing lateralization and motor functions. | Baseline and 5, 10, 15 years | 
| Change of cytokines concentration in serum | Change of concentration of cytokines in serum (pg/ml): (IL-1b, IFN-alpha, IFN-gamma, TNF-alpha, MCP-1, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33). | Baseline and 5, 10, 15 years | 
| Change of functional activiy of T cells and Natural Killer cells | Change of functional activities of T cells and natural killer cells in %. | Baseline and 5, 10, 15 years | 
| Change of peripheral blood mononuclear cells concentration | Change of peripheral blood mononuclear cells concentration (pg/ml): (PBMC; CD14 positive monocytes). | Baseline and 5, 10, 15 years | 
| Change in physical performance | Change of physical fitness assessed by bicycle ergometer and a physical work capacity cycle test (PWC-130) to predict the absolute power output (in Watt) at a projected heart rate of 130 beats per minute. A relative power output is calculated by the power-to-weight ratio (Watt/kg). | Baseline and 5, 10, 15 years | 
| Change in cardiovascular parameters | Diastolic and systolic blood pressure (mm/Hg) and pulse (bpm) measured during rest and during cycle ergometry. | Baseline and 5, 10, 15 years | 
| Change in electrocardiography | Change in electrocardiogram (ECG) measured during rest and during cycle ergometry. | Baseline and 5, 10, 15 years | 
| Change in antibody concentrations of Toxoplasma gondii in serum | Change of concentration of Toxoplasma gondii IgG antibodies (pg/ml) in serum to assess the severity of latent toxoplasmosis infection. | Baseline and 5, 10, 15 years | 
| Change in antibody concentrations of COVID-19 in serum | Concentration of COVID-19 antibodies (pg/ml) in serum to assess the intensity of immunological response to potential SARC-CoV-2 infection or response to vaccination. | 5, 10, 15 years | 
| Change in metabolic parameters in blood | Change in metabolic parameters in serum (pg/ml): concentration of ammonia, leucocytes, erythrocytes, hematocrit, monocytes, creatinine, lymphocytes, cell volume, thrombocytes, triglycerides, cholesterol, high- and low-density lipoprotein cholesterol, glycosylated hemoglobin, glucose, C-reactive protein and creatinine are measured in venous blood. | Baseline and 5, 10, 15 years | 
| Change of metabolic parameters in urine | Change in metabolic parameters in urine (pg/ml): concentartion of creatinine and calcium oxalate. | Baseline and 5, 10, 15 years | 
| Change of endocrine parameter | Change of hair cortisol concentration (pg/mg) as an index of long-term stress. | Baseline and 5, 10, 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG, Cardiovascular System, Behavioral Genetics, Immunology, MRI, Cognitive Ageing, Occupational Health, Neuropsychology, Metabolism