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

November 27, 2024 updated by: Technical University of Dortmund

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

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 (Actual)

627

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dortmund, Germany, 44139
        • Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy individuals from the general population.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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).
Baseline and 5, 10, 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 5, 10, 15 years
Change in brain function MRI
Time Frame: 5, 10, 15 years
Changes in functional magnetic resonance imaging assessed by resting state MRI.
5, 10, 15 years
Change in brain structure MRI
Time Frame: 5, 10, 15 years
Changes in structural resonance imaging assessed by multi-shell diffusion-weighted imaging (DWI).
5, 10, 15 years
Change in Depressive Symptoms
Time Frame: Baseline and 5, 10, 15 years
Change in total score using the Becks Depression Inventory (BDI).
Baseline and 5, 10, 15 years
Change in Psychosocial Stress Symptoms
Time Frame: Baseline and 5, 10, 15 years
Change in total score using the Psychosocial Stress Questionnaire (PSQ-20).
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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).
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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).
Baseline and 5, 10, 15 years
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 %.
Baseline and 5, 10, 15 years
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).
Baseline and 5, 10, 15 years
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).
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
Change in electrocardiography
Time Frame: Baseline and 5, 10, 15 years
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
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.
Baseline and 5, 10, 15 years
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.
5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline
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).
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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).
Baseline and 5, 10, 15 years
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.
Baseline and 5, 10, 15 years
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.
Baseline
Stress reactivity
Time Frame: Baseline
Subjective stress reactivity are assessed by the Perceived Stress Reactivity Scale (PSRS).
Baseline
Chronotype
Time Frame: Baseline
The chronotype assessing the morning or evening type is evaluated by (D-MEQ).
Baseline
Handedness
Time Frame: Baseline
Handedness is evaluated by Handedness Edinburgh Inventory.
Baseline
Traumatic Experiences During Childhood
Time Frame: Baseline
Traumatic experiences during childhood are assessed to evaluate stress reactivity in the adult life.
Baseline
Sociodemographic characteristics
Time Frame: Baseline
Sociodemographic characteristics like education, history of physical activity, marital status, children etc. were obtained. Qualitative data are categorized.
Baseline
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).
5, 10, 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Edmund Wascher, PhD, Leibniz Research Centre for Working Environment and Human Factors at the TU Dortmund (IfADo)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2037

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 13, 2021

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • A93-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After primary analyses and publication of the main results.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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