NCT05155397

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
627

participants targeted

Target at P75+ for all trials

Timeline
141mo left

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Apr 2016Dec 2037

Study Start

First participant enrolled

April 1, 2016

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2037

Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

19.7 years

First QC Date

November 16, 2021

Last Update Submit

November 27, 2024

Conditions

Keywords

Cognitive AgeingOccupational HealthNeuropsychologyMetabolismCardiovascular SystemBehavioral GeneticsImmunologyEEGMRIpsychoneuroendocrinologyInfectious diseasesCognitive Neuroscience

Outcome Measures

Primary Outcomes (13)

  • 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 Outcomes (27)

  • Change in resting state EEG activity

    baseline and 5, 10, 15 years

  • Change in brain function MRI

    5, 10, 15 years

  • Change in brain structure MRI

    5, 10, 15 years

  • Change in Depressive Symptoms

    Baseline and 5, 10, 15 years

  • Change in Burnout Symptoms

    Baseline and 5, 10, 15 years

  • +22 more secondary outcomes

Other Outcomes (12)

  • Genetic parameters (Single Nucleotide Polymorphisms; SNP)

    Baseline

  • Change in visual acuity

    Baseline and 5, 10, 15 years

  • Change in auditory acuity

    Baseline and 5, 10, 15 years

  • +9 more other outcomes

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy individuals from the general population.

You may qualify if:

  • Blood thinners
  • Hormones
  • Antihypertensives
  • Cholesterol reducers
  • Normal or corrected-to-normal vision and hearing
  • Sufficient language skills

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dortmund, 44139, Germany

Location

Related Publications (28)

  • 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.

    PMID: 35285810BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Larra MF, Gajewski PD, Getzmann S, Wascher E, Metzler Y. Stress from early life to adulthood: Is there a protective role of cognitive control? Brain Cogn. 2024 Aug;178:106165. doi: 10.1016/j.bandc.2024.106165. Epub 2024 May 16.

  • Getzmann S, Golka K, Brode P, Reinders J, Kadhum T, Hengstler JG, Wascher E, Gajewski PD. Chronic Toxoplasma gondii Infection Modulates Hearing Ability across the Adult Life Span. Life (Basel). 2024 Jan 29;14(2):194. doi: 10.3390/life14020194.

  • 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.

  • Gajewski PD, Golka K, Hengstler JG, Kadhum T, Digutsch J, Genc E, Wascher E, Getzmann S. Does physical fitness affect cognitive functions differently across adulthood? An advantage of being older. Front Psychol. 2023 Jun 16;14:1134770. doi: 10.3389/fpsyg.2023.1134770. eCollection 2023.

  • Rieker JA, Gajewski PD, Reales JM, Ballesteros S, Golka K, Hengstler JG, Wascher E, Getzmann S. The impact of physical fitness, social life, and cognitive functions on work ability in middle-aged and older adults. Int Arch Occup Environ Health. 2023 May;96(4):507-520. doi: 10.1007/s00420-022-01943-8. Epub 2022 Dec 16.

  • Akan O, Bierbrauer A, Kunz L, Gajewski PD, Getzmann S, Hengstler JG, Wascher E, Axmacher N, Wolf OT. Chronic stress is associated with specific path integration deficits. Behav Brain Res. 2023 Mar 28;442:114305. doi: 10.1016/j.bbr.2023.114305. Epub 2023 Jan 20.

  • Getzmann S, Arnau S, Gajewski PD, Wascher E. When long appears short: Effects of auditory distraction on event-related potential correlates of time perception. Eur J Neurosci. 2022 Jan;55(1):121-137. doi: 10.1111/ejn.15553. Epub 2021 Dec 14.

  • Getzmann S, Schneider D, Wascher E. Selective spatial attention in lateralized multi-talker speech perception: EEG correlates and the role of age. Neurobiol Aging. 2023 Jun;126:1-13. doi: 10.1016/j.neurobiolaging.2023.02.003. Epub 2023 Feb 14.

  • Wascher E, Sharifian F, Gutberlet M, Schneider D, Getzmann S, Arnau S. Mental chronometry in big noisy data. PLoS One. 2022 Jun 8;17(6):e0268916. doi: 10.1371/journal.pone.0268916. eCollection 2022.

  • Sharifian F, Schneider D, Arnau S, Wascher E. Decoding of cognitive processes involved in the continuous performance task. Int J Psychophysiol. 2021 Sep;167:57-68. doi: 10.1016/j.ijpsycho.2021.06.012. Epub 2021 Jul 1.

  • Getzmann S, Digutsch J, Kleinsorge T. COVID-19 Pandemic and Personality: Agreeable People Are More Stressed by the Feeling of Missing. Int J Environ Res Public Health. 2021 Oct 13;18(20):10759. doi: 10.3390/ijerph182010759.

  • 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.

  • Bierbrauer A, Kunz L, Gomes CA, Luhmann M, Deuker L, Getzmann S, Wascher E, Gajewski PD, Hengstler JG, Fernandez-Alvarez M, Atienza M, Cammisuli DM, Bonatti F, Pruneti C, Percesepe A, Bellaali Y, Hanseeuw B, Strange BA, Cantero JL, Axmacher N. Unmasking selective path integration deficits in Alzheimer's disease risk carriers. Sci Adv. 2020 Aug 28;6(35):eaba1394. doi: 10.1126/sciadv.aba1394. eCollection 2020 Aug.

  • 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.

  • 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.

  • 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.

  • Gajewski PD, Rieker JA, Athanassiou G, Brode P, Claus M, Golka K, Hengstler JG, Kleinsorge T, Nitsche MA, Reinders J, Tisch A, Watzl C, Wascher E, Getzmann S. A Systematic Analysis of Biological, Sociodemographic, Psychosocial, and Lifestyle Factors Contributing to Work Ability Across the Working Life Span: Cross-sectional Study. JMIR Form Res. 2023 May 19;7:e40818. doi: 10.2196/40818.

  • Brode P, Claus M, Getzmann S, Golka K, Hengstler JG, Reinders J, Wascher E, Watzl C, Gajewski PD. Latent Toxoplasma gondii Infection Does Not Modulate Immune Aging in a Cross-Sectional Working-Age Population Study. Biomolecules. 2025 Dec 30;16(1):55. doi: 10.3390/biom16010055.

  • Engler R, Stammen C, Arnau S, Schneider Penate J, Metzen D, Digutsch J, Gajewski PD, Getzmann S, Fraenz C, Reinders J, Voelkle MC, Streit F, Ocklenburg S, Schneider D, Burke M, Hengstler JG, Watzl C, Nitsche MA, Kumsta R, Wascher E, Genc E. Electrophysiological resting-state signatures link polygenic scores to general intelligence. Sci Rep. 2025 Nov 21;15(1):41170. doi: 10.1038/s41598-025-26778-4.

  • Gajewski PD, Brode P, Claus M, Golka K, Hengstler JG, Reinders J, Watzl C, Wascher E, Getzmann S. Changes of cognitive functions and proinflammatory cytokines across the lifespan in latent Toxoplasma gondii infection. Brain Behav Immun Health. 2025 Sep 15;49:101105. doi: 10.1016/j.bbih.2025.101105. eCollection 2025 Nov.

  • Gajewski PD, Brode P, Claus M, Golka K, Hengstler JG, Watzl C, Wascher E, Getzmann S. The association between hair cortisol and burnout is moderated by age, psychosocial, and immunological markers. Brain Behav Immun Health. 2024 Nov 23;43:100909. doi: 10.1016/j.bbih.2024.100909. eCollection 2025 Feb.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood, serum, urine, hair samples

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Edmund Wascher, PhD

    Leibniz Research Centre for Working Environment and Human Factors at the TU Dortmund (IfADo)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

December 13, 2021

Study Start

April 1, 2016

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2037

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
After primary analyses and publication of the main results.
Access Criteria
In order to access the data, scientists from IfADo, as well as external cooperation partners who plan to analyze data from the Dortmund Vital Study fill in a proposal form that includes a short description of the project and the respective hypotheses, the responsible persons, cooperation partners, data usage and analysis strategy. The requested research data will be made available in an anonymized form after consultation with the scientists responsible for the data. Responsible persons include project managers and coordinators of the Dortmund Vital Study in consultation with the IfADo Research Data Management Unit.

Locations