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

N/AActive Not RecruitingNCT05155397

Technical University of Dortmund627 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

627

Conditions

Age-related Cognitive Decline

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors

Dortmund, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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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