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NCT Number: NCT05155397

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

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Dortmund, 44139, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: Baseline and 5, 10, 15 years

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

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

    Time frame: Baseline and 5, 10, 15 years

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

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

    Time frame: Baseline and 5, 10, 15 years

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

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

    Time frame: Baseline and 5, 10, 15 years

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

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

    Time frame: Baseline and 5, 10, 15 years

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

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

    Time frame: Baseline and 5, 10, 15 years

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

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

    Time frame: Baseline and 5, 10, 15 years

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

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

    Time frame: Baseline and 5, 10, 15 years

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

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

    Time frame: Baseline and 5, 10, 15 years

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

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

    Time frame: Baseline and 5, 10, 15 years

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

  13. Change in Work Ability Index

    Time frame: 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).

Secondary outcomes

  1. Change in resting state EEG activity

    Time frame: baseline and 5, 10, 15 years

    Change in resting state EEG activity measured for 2 minutes with eyes open, and 2 minutes with eyes closed.

  2. Change in brain function MRI

    Time frame: 5, 10, 15 years

    Changes in functional magnetic resonance imaging assessed by resting state MRI.

  3. Change in brain structure MRI

    Time frame: 5, 10, 15 years

    Changes in structural resonance imaging assessed by multi-shell diffusion-weighted imaging (DWI).

  4. Change in Depressive Symptoms

    Time frame: Baseline and 5, 10, 15 years

    Change in total score using the Becks Depression Inventory (BDI).

  5. Change in Burnout Symptoms

    Time frame: Baseline and 5, 10, 15 years

    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.

  6. Change in Burnout Symptoms

    Time frame: Baseline and 5, 10, 15 years

    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.

  7. Change in Psychosocial Stress Symptoms

    Time frame: Baseline and 5, 10, 15 years

    Change in total score using the Psychosocial Stress Questionnaire (PSQ-20).

  8. Change in Chronic Stress Symptoms

    Time frame: Baseline and 5, 10, 15 years

    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.

  9. Change in Psychosocial Work Demands

    Time frame: 5, 10, 15 years

    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.

  10. Change in Self-Control at work

    Time frame: Baseline and 5, 10, 15 years

    Change of the psychosocial demands at work assessed by the scale Self-Control at Work.

  11. Change in Cognitive Failures in the Daily Life

    Time frame: Baseline and 5, 10, 15 years

    Change in cognitive failures in daily life assessed by the Cognitive Failure Questionnaire (CFQ).

  12. Change in Positive and Negative Affect

    Time frame: Baseline and 5, 10, 15 years

    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.

  13. Change in Quality of Life

    Time frame: Baseline and 5, 10, 15 years

    Change in total score of the quality of life questionnaire (WHOQoL-BREF), consisting of dimensions: physical, psychological, social, environmental, and global quality of life.

  14. Change in sociodemographic parameters

    Time frame: Baseline and 5, 10, 15 years

    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.

  15. Change in self-reported physical activity

    Time frame: Baseline and 5, 10, 15 years

    Change of the self-reported physical activity (Lüdenscheid Physical Activity Questionnaire) in minutes per week.

  16. Change in lateralization and motor functions

    Time frame: Baseline and 5, 10, 15 years

    Change in total score of the Perdue Pegboard Test, assessing lateralization and motor functions.

  17. Change of cytokines concentration in serum

    Time frame: Baseline and 5, 10, 15 years

    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).

  18. Change of functional activiy of T cells and Natural Killer cells

    Time frame: Baseline and 5, 10, 15 years

    Change of functional activities of T cells and natural killer cells in %.

  19. Change of peripheral blood mononuclear cells concentration

    Time frame: Baseline and 5, 10, 15 years

    Change of peripheral blood mononuclear cells concentration (pg/ml): (PBMC; CD14 positive monocytes).

  20. Change in physical performance

    Time frame: Baseline and 5, 10, 15 years

    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).

  21. Change in cardiovascular parameters

    Time frame: Baseline and 5, 10, 15 years

    Diastolic and systolic blood pressure (mm/Hg) and pulse (bpm) measured during rest and during cycle ergometry.

  22. Change in electrocardiography

    Time frame: Baseline and 5, 10, 15 years

    Change in electrocardiogram (ECG) measured during rest and during cycle ergometry.

  23. Change in antibody concentrations of Toxoplasma gondii in serum

    Time frame: Baseline and 5, 10, 15 years

    Change of concentration of Toxoplasma gondii IgG antibodies (pg/ml) in serum to assess the severity of latent toxoplasmosis infection.

  24. Change in antibody concentrations of COVID-19 in serum

    Time frame: 5, 10, 15 years

    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.

  25. Change in metabolic parameters in blood

    Time frame: Baseline and 5, 10, 15 years

    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.

  26. Change of metabolic parameters in urine

    Time frame: Baseline and 5, 10, 15 years

    Change in metabolic parameters in urine (pg/ml): concentartion of creatinine and calcium oxalate.

  27. Change of endocrine parameter

    Time frame: Baseline and 5, 10, 15 years

    Change of hair cortisol concentration (pg/mg) as an index of long-term stress.

Other outcomes

  1. Genetic parameters (Single Nucleotide Polymorphisms; SNP)

    Time frame: Baseline

    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).

  2. Change in visual acuity

    Time frame: Baseline and 5, 10, 15 years

    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).

  3. Change in auditory acuity

    Time frame: Baseline and 5, 10, 15 years

    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.

  4. Change in Body Mass Index

    Time frame: Baseline and 5, 10, 15 years

    Height (m) and weight (kg) are measured to compute the Body Mass Index (BMI in kg/m^2).

  5. Change in Waist-To-Hip ratio

    Time frame: Baseline and 5, 10, 15 years

    Waist- and hip measurements (cm) are measured to compute the waist-to-hip ratio.

  6. Personality traits

    Time frame: Baseline

    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.

  7. Stress reactivity

    Time frame: Baseline

    Subjective stress reactivity are assessed by the Perceived Stress Reactivity Scale (PSRS).

  8. Chronotype

    Time frame: Baseline

    The chronotype assessing the morning or evening type is evaluated by (D-MEQ).

  9. Handedness

    Time frame: Baseline

    Handedness is evaluated by Handedness Edinburgh Inventory.

  10. Traumatic Experiences During Childhood

    Time frame: Baseline

    Traumatic experiences during childhood are assessed to evaluate stress reactivity in the adult life.

  11. Sociodemographic characteristics

    Time frame: Baseline

    Sociodemographic characteristics like education, history of physical activity, marital status, children etc. were obtained. Qualitative data are categorized.

  12. Experiences with COVID-19 pandemic

    Time frame: 5, 10, 15 years

    Questionnaire addressing COVID-19-specific experience with the pandemic and the consequences of a COVID-19 infection (if applicable).

Sponsors and collaborators

Lead sponsor

Technical University of Dortmund

Other

Registry information

Official study 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

Acronym: DVS

Important dates

Study start
2016
Primary completion
2035
Study completion
2037
First posted
Dec 13, 2021
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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