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

Age-related Cognitive Decline Clinical Trial

— DVS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05155397
• Other study ID #: A93-3
• Status: Active, not recruiting
• Start date: April 2016
• Est. completion date: December 2037

Study information

• Verified date: June 2023
• Source: Technical University of Dortmund
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 613
• Est. completion date: December 2037
• Est. primary completion date: December 2035
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

Locations

Country	Name	City	State
Germany	Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors	Dortmund

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Dortmund

Country where clinical trial is conducted

Germany, 

References & Publications (14)

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 J — View Citation

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 s — View Citation

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. — View Citation

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. — View Citation

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/fps — View Citation

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 Contr — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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- — View Citation

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. — View Citation

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;9 — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genetic parameters (Single Nucleotide Polymorphisms; SNP)	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
Other	Change in visual acuity	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
Other	Change in auditory acuity	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
Other	Change in Body Mass Index	Height (m) and weight (kg) are measured to compute the Body Mass Index (BMI in kg/m^2).	Baseline and 5, 10, 15 years
Other	Change in Waist-To-Hip ratio	Waist- and hip measurements (cm) are measured to compute the waist-to-hip ratio.	Baseline and 5, 10, 15 years
Other	Personality traits	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
Other	Stress reactivity	Subjective stress reactivity are assessed by the Perceived Stress Reactivity Scale (PSRS).	Baseline
Other	Chronotype	The chronotype assessing the morning or evening type is evaluated by (D-MEQ).	Baseline
Other	Handedness	Handedness is evaluated by Handedness Edinburgh Inventory.	Baseline
Other	Traumatic Experiences During Childhood	Traumatic experiences during childhood are assessed to evaluate stress reactivity in the adult life.	Baseline
Other	Sociodemographic characteristics	Sociodemographic characteristics like education, history of physical activity, marital status, children etc. were obtained. Qualitative data are categorized.	Baseline
Other	Experiences with COVID-19 pandemic	Questionnaire addressing COVID-19-specific experience with the pandemic and the consequences of a COVID-19 infection (if applicable).	5, 10, 15 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	baseline and 5, 10, 15 years
Secondary	Change in brain function MRI	Changes in functional magnetic resonance imaging assessed by resting state MRI.	5, 10, 15 years
Secondary	Change in brain structure MRI	Changes in structural resonance imaging assessed by multi-shell diffusion-weighted imaging (DWI).	5, 10, 15 years
Secondary	Change in Depressive Symptoms	Change in total score using the Becks Depression Inventory (BDI).	Baseline and 5, 10, 15 years
Secondary	Change in Burnout Symptoms	Change in total score using the Maslach Burnout Inventory (MBI-GS).	Baseline and 5, 10, 15 years
Secondary	Change in Psychosocial Stress Symptoms	Change in total score using the Psychosocial Stress Questionnaire (PSQ-20).	Baseline and 5, 10, 15 years
Secondary	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.	Baseline and 5, 10, 15 years
Secondary	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.	5, 10, 15 years
Secondary	Change in Self-Control at work	Change of the psychosocial demands at work assessed by the scale Self-Control at Work.	Baseline and 5, 10, 15 years
Secondary	Change in Cognitive Failures in the Daily Life	Change in cognitive failures in daily life assessed by the Cognitive Failure Questionnaire (CFQ).	Baseline and 5, 10, 15 years
Secondary	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.	Baseline and 5, 10, 15 years
Secondary	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.	Baseline and 5, 10, 15 years
Secondary	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.	Baseline and 5, 10, 15 years
Secondary	Change in self-reported physical activity	Change of the self-reported physical activity (Lüdenscheid Physical Activity Questionnaire) in minutes per week.	Baseline and 5, 10, 15 years
Secondary	Change in lateralization and motor functions	Change in total score of the Perdue Pegboard Test, assessing lateralization and motor functions.	Baseline and 5, 10, 15 years
Secondary	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).	Baseline and 5, 10, 15 years
Secondary	Change of functional activiy of T cells and Natural Killer cells	Change of functional activities of T cells and natural killer cells in %.	Baseline and 5, 10, 15 years
Secondary	Change of peripheral blood mononuclear cells concentration	Change of peripheral blood mononuclear cells concentration (pg/ml): (PBMC; CD14 positive monocytes).	Baseline and 5, 10, 15 years
Secondary	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).	Baseline and 5, 10, 15 years
Secondary	Change in cardiovascular parameters	Diastolic and systolic blood pressure (mm/Hg) and pulse (bpm) measured during rest and during cycle ergometry.	Baseline and 5, 10, 15 years
Secondary	Change in electrocardiography	Change in electrocardiogram (ECG) measured during rest and during cycle ergometry.	Baseline and 5, 10, 15 years
Secondary	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.	Baseline and 5, 10, 15 years
Secondary	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.	5, 10, 15 years
Secondary	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.	Baseline and 5, 10, 15 years
Secondary	Change of metabolic parameters in urine	Change in metabolic parameters in urine (pg/ml): concentartion of creatinine and calcium oxalate.	Baseline and 5, 10, 15 years
Secondary	Change of endocrine parameter	Change of hair cortisol concentration (pg/mg) as an index of long-term stress.	Baseline and 5, 10, 15 years