An observational study in Age-related Cognitive Decline, sponsored by Technical University of Dortmund. Active, not recruiting at 1 site in Germany. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Technical University of Dortmund · Observational
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.
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.
Healthy individuals from the general population.
Exclusion Criteria:
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline and 5, 10, 15 years
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.
Time frame: baseline and 5, 10, 15 years
Change in brain function MRI
Changes in functional magnetic resonance imaging assessed by resting state MRI.
Time frame: 5, 10, 15 years
Change in brain structure MRI
Changes in structural resonance imaging assessed by multi-shell diffusion-weighted imaging (DWI).
Time frame: 5, 10, 15 years
Change in Depressive Symptoms
Change in total score using the Becks Depression Inventory (BDI).
Time frame: Baseline and 5, 10, 15 years
Change in Burnout Symptoms
Change in total score using the Maslach Burnout Inventory (MBI-D) with 6-point Likert-type scale ranging from 1 (never) to 6 (always), total scores: 14 - 84. Higher scores indicate more severe symptoms.
Time frame: Baseline and 5, 10, 15 years
Change in Burnout Symptoms
Change in total score using the Oldenburg Burnout Inventory (OLBI). 4-point Likert-type scale ranging from 1 (strongly agree) to 4 (strongly disagree), total scores: 8 - 32. Higher scores indicate more severe symptoms.
Time frame: Baseline and 5, 10, 15 years
Change in Psychosocial Stress Symptoms
Change in total score using the Psychosocial Stress Questionnaire (PSQ-20).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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 %.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline and 5, 10, 15 years
Change in electrocardiography
Change in electrocardiogram (ECG) measured during rest and during cycle ergometry.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 5, 10, 15 years
Change of endocrine parameter
Change of hair cortisol concentration (pg/mg) as an index of long-term stress.
Time frame: Baseline and 5, 10, 15 years
Genetic parameters (Single Nucleotide Polymorphisms; SNP)
A number of genetic polymorphisms coding common homozygotes, heterozygotes and rare homozygotes variants were selected which are potentially related to structure and function of the central nervous system. Blood samples were used for the DNA-genotyping of: Apo-E2, E3, E4 (rs7412, rs429358), BDNF Val66Met (rs6265), COMT-1 (rs4633), COMT-2 Val158Met (rs4680), DRD2 (rs6277, DRD1-48A/G (rs4532), CHRNA6-1 (rs1072003), CHRNA6-3 (rs2304297), CHRNB3-1 (rs13280604), CHRNB3-2 (rs4950), GPCPD1 (EDI3) (rs)6116869), GRIN2A (rs1969060), GRIN2A (rs8057394), GRIN2B (rs890), IL-1beta (rs16944), IL-6 (rs1800795), IL-12A (rs568408), TNF-alpha (rs1800629).
Time frame: Baseline
Change in visual acuity
Change in visual acuity assessed by Vistec's Optovist according to DIN 58220-3 "Visual acuity testing - Part 3: Test for use in expertise" for far vision with the right and left eye separately (monocular) and with both eyes together (binocular), and if available with correction for distance (glasses for far vision). The "inclined optometer" is used to determine the zones of sufficient vision binocular at horizontal gaze inclination. For this, the near and far points are obtained, if available with distance correction (glasses for far vision).
Time frame: Baseline and 5, 10, 15 years
Change in auditory acuity
Change in auditory acuity evaluated by audiometry. Audiometric thresholds are tested for ten pure-tone frequencies (125, 250, 500, 750, 1000, 2000, 3000, 4000, 6000, 8000 Hz) for the left and right ears separately.
Time frame: Baseline and 5, 10, 15 years
Change in Body Mass Index
Height (m) and weight (kg) are measured to compute the Body Mass Index (BMI in kg/m\^2).
Time frame: Baseline and 5, 10, 15 years
Change in Waist-To-Hip ratio
Waist- and hip measurements (cm) are measured to compute the waist-to-hip ratio.
Time frame: Baseline and 5, 10, 15 years
Personality traits
Personality traits are evaluated by the Big-Five-Factor inventory (NEO-FFI), assessing the personality dimensions: neuroticism, extraversion, openness, agreeableness, and conscientiousness. Grit personality trait are assessed by the GRID scale and the self-control by the general self-control scale.
Time frame: Baseline
Stress reactivity
Subjective stress reactivity are assessed by the Perceived Stress Reactivity Scale (PSRS).
Time frame: Baseline
Chronotype
The chronotype assessing the morning or evening type is evaluated by (D-MEQ).
Time frame: Baseline
Handedness
Handedness is evaluated by Handedness Edinburgh Inventory.
Time frame: Baseline
Traumatic Experiences During Childhood
Traumatic experiences during childhood are assessed to evaluate stress reactivity in the adult life.
Time frame: Baseline
Sociodemographic characteristics
Sociodemographic characteristics like education, history of physical activity, marital status, children etc. were obtained. Qualitative data are categorized.
Time frame: Baseline
Experiences with COVID-19 pandemic
Questionnaire addressing COVID-19-specific experience with the pandemic and the consequences of a COVID-19 infection (if applicable).
Time frame: 5, 10, 15 years
Plan to share: Yes — After primary analyses and publication of the main results the data and the scripts used for data analyses will be made available in repositories for secondary analyses. The transfer agreement will be prepared by the coordinators of the Dortmund Vital Study in consultation with the IfADo Research Data Management Unit.
Supporting information: Study protocol, Analytic code
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Technical University of Dortmund