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

• ClinicalTrials.gov Identifier: NCT05155397
• Recruitment Status: Enrolling by invitation
• First Posted: December 13, 2021
• Last Update Posted: May 2, 2022
• Sponsor: Technical University of Dortmund
• Information provided by (Responsible Party): Technical University of Dortmund

Study Description

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.

Condition or disease
Age-related Cognitive Decline

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 Design

• Study Type: Observational
• Estimated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official 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
• Actual Study Start Date: April 2016
• Estimated Primary Completion Date: December 2035
• Estimated Study Completion Date: December 2037

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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-GS).
6. Change in Psychosocial Stress Symptoms [ Time Frame: Baseline and 5, 10, 15 years ]
   Change in total score using the Psychosocial Stress Questionnaire (PSQ-20).
7. 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.
8. 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.
9. 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.
10. 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).
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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).
17. 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 %.
18. 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).
19. 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).
20. 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.
21. Change in electrocardiography [ Time Frame: Baseline and 5, 10, 15 years ]
    Change in electrocardiogram (ECG) measured during rest and during cycle ergometry.
22. 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.
23. 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.
24. 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.
25. 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.
26. 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 Outcome Measures:

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).

Biospecimen Retention:   Samples With DNA

Peripheral venous blood, serum, urine, hair samples

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Healthy individuals from the general population.

Criteria

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

Contacts and Locations

Locations

Germany

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

Dortmund, Germany, 44139

Sponsors and Collaborators

Technical University of Dortmund

Investigators

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

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Technical University of Dortmund
• ClinicalTrials.gov Identifier: NCT05155397
• Other Study ID Numbers: A93-3
• First Posted: December 13, 2021
• Last Update Posted: May 2, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Technical University of Dortmund:

Cognitive Ageing; Occupational Health; Neuropsychology; Metabolism; Cardiovascular System; Behavioral Genetics; Immunology; EEG; MRI

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders