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Healthy AdultsNCT07130825

The Effect of Different Physical Activity Strategy on Cognitive Efficiency and Mental Fatigue Resistance

A study testing 8 hours simulated mental workday, Moderate intensity aerobic activity and Combined work model in people with Healthy Adults, run by Lithuanian Sports University at 1 site in Lithuania.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main aim of this biomedical study is to determine the effect of moderate-intensity aerobic exercise, before and after an 8-hour workday and a combined work model, on the performance and efficiency of cognitive functions during mental work. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adults
What is being tested?
8 hours simulated mental workday, Moderate intensity aerobic activity and Combined work model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteLithuania
Study dates
1 Aug 2025to 1 Mar 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • BMI from 18.5 to 24.9 kg/ m2;
  • No chronic non-communicable diseases;
  • No mental illnesses or disorders;
  • No cancer and no chemotherapy in the last 5 years;
  • No hearing impairment;
  • No smoking;
Show all 11Show fewer
  • No psychotropic substances;
  • Heart rate (HR) about 60 bpm at rest;
  • Unimpaired color vision;
  • Unimpaired or corrected vision;
  • Systolic blood pressure from 90 to 139 mmHg, and diastolic - from 50 to 89 mmHg at rest.

Who cannot join

  • mental, oncological, metabolic, cardiovascular, skeletal, muscular, respiratory system disorders or diseases, impaired color vision.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marius Brazaitis, professor contact

+37067059637

marius.brazaitis@lsu.lt

Aura Mažuolytė-Binderienė contact

+37061515610

aura.mazuolyte-binderiene@stud.lsu.lt

Lithuania1 site, 1 recruiting
  • Institute of Sport Science and Innovations

    Kaunas

    Marius Brazaitis, PhD, marius.brazaitis@lsu.lt

    Recruiting

Other trials in Lithuania

About this study

Official title: The Effect of Different Physical Activity Strategy on Cognitive Efficiency and Mental Fatigue Resistance During a Simulated Mental Working Day

The main aim of this biomedical study is to determine the effect of moderate-intensity aerobic exercise, before and after an 8-hour workday and a combined work model, on the performance and efficiency of cognitive functions during mental work.

There are lack of previous studies analysing the effects of different physical activity strategies on cognitive efficiency and investigating mental fatigue resistance. Limited research in this area shows that the mechanism of the effect of physical activity on mental fatigue resistance is still unclear. This research will aim to investigate different physical activity strategies, such as combined work model and moderate intensity physical activity before and after office workday, and their impact on a mental and emotional fatigue, cognitive efficiency, sympathetic and parasympathetic systems and metabolic indicators during mentally demanding 8 h workday.

Read the detailed description

Prolonged sedentary behavior and sustained cognitive workload during typical office workdays contribute significantly to the onset of acute mental fatigue (Kunasegaran et al., 2023). This condition is linked to physiological mechanisms such as reduced cerebral blood flow, diminished glucose availability and transport to active brain regions (García et al., 2021; Kennedy \& Scholey, 2000), as well as hormonal alterations (Miyashita \& Williams, 2006; Wiehler et al., 2022). These changes negatively impact cognitive efficiency, motivation, and overall brain function (Kunasegaran et al., 2023; Tran et al., 2020). While existing evidence supports the positive influence of physical activity on physical and mental health (Calderwood et al., 2021; Jacquet et al., 2021), there remains a lack of research specifically examining how different physical activity strategies influence cognitive efficiency and resistance to mental fatigue.

This study aims to address this gap by investigating the effects of various physical activity interventions, including a combined work-exercise model and moderate-intensity aerobic exercise performed either before or after an 8-hour mentally demanding workday. Outcomes will focus on mental and emotional fatigue, cognitive efficiency, autonomic nervous system activity (sympathetic and parasympathetic balance), and metabolic responses. By evaluating these parameters, the study seeks to clarify the potential of targeted physical activity strategies to enhance mental fatigue resistance and support cognitive performance in occupational settings. The findings are expected to contribute valuable insight into the development of effective workplace interventions that promote employee well-being, productivity, and resilience.

Conditions
Healthy Adults
Being tested
8 hours simulated mental workday, Moderate intensity aerobic activity, Combined work model

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 8 hours simulated mental workdayOther

    During a simulated 8-hour mental work day, subjects will complete a set of cognitive tests (ANAM4, version 4; Vista Life Science, Norman, OK, USA) 8 times (1 session approximately 45 minutes), with a break of approximately 10 minutes after each session.

  • Moderate intensity aerobic activityOther

    In one of the conditions, subjects will perform moderate intensity aerobic activity (cycle veloergometer) for 30 min before 8 hours simulated mental workday and after.

  • Combined work modelOther

    In one of the conditions, subjects will perform cognitive test during 8 hours simulated mental workday applying combined work model (they will work standing and sitting on a balance ball).

Study groups in NCT07130825
Study groupRoleWhat they receive
ControlExperimentalHealthy young subjects will participate in research "control" condition attending 8 h simulated working day. During simulated working day subjects will perform cognitive tasks (ANAM4, version 4; Vista Life Science, Norman, OK, USA) for 8 times (1 session 11 tests about 45 min). The effect of a mental workday on cognitive function indicators will be evaluated. Same participants will participate in 3 research trials (control, aerobic activity and combined work model).
Receives: Other: 8 hours simulated mental workday
Aerobic activityExperimentalHealthy young subjects will participate in research "aerobic activity" condition attending 8 h simulated working day. Subjects will cycle 30 min on a veloergometer in a 50 % of maximal capacity before the cognitive tasks and after them (before and after simulated 8 h workday). During simulated working day subjects will perform cognitive tasks (ANAM4, version 4; Vista Life Science, Norman, OK, USA) for 8 times (1 session 11 tests about 45 min). The effect of a moderate-intensity aerobic physical activity before and after 8 hours of a mental workday will be evaluated. Same participants will participate in 3 research trials (control, aerobic activity and combined work model).
Receives: Other: 8 hours simulated mental workday; Other: Moderate intensity aerobic activity
Combined work modelExperimentalHealthy young subjects will participate in research "combined work model" condition attending 8 h simulated working day. Subjects will perform cognitive tasks applying combined work model, which means that participants will be changing their positions from sitting on a balance ball to standing while performing cognitive tasks. During simulated working day subjects will perform cognitive tasks (ANAM4, version 4; Vista Life Science, Norman, OK, USA). The effect of a the combined work model on cognitive functions indicators during a simulated 8 h mental working day will be evaluated. Same participants will participate in 3 research trials (control, aerobic activity and combined work model).
Receives: Other: 8 hours simulated mental workday; Other: Combined work model

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body mass and body composition (kg)

    Body mass and composition (in kilograms) will be evaluated using Tanita Body Composition Analyzer (Japan).

    Measured: 2 times in the mornings (day 1 and day 2) of each 3 conditions.

  2. Height (m)

    Height (in meters) will be measured using a Harpenden anthropometer set (Holtain Ltd, UK).

    Measured: 2 times in the mornings (day 1 and day 2) of each 3 conditions.

  3. Brain hemodynamic response

    To measure and evaluate hemodynamic response, a functional near-infrared (fNIRS) device NIRx NIRS Sport2 (Medical Technologies LLC-NIR-Scout, USA) with 8 near-infrared (NIR) radiation sources and 7 photodetectors will be used. The photodetectors record the relative changes in oxygen and oxygenated hemoglobin at 7.81 Hz for both wavelengths. The probes are placed at the manufacturer's specified locations to capture the hemodynamic response of the prefrontal cortex. Live recording will be monitored for 6 minutes.

    Measured: Before, immediately after the simulated mental workday, 3 hours after the simulated mental workday, and 12 hours recovery after a simulated mental workday in 3 conditions.

  4. Cognitive performance

    Automated Neuropsychological Assessment Metrics Test Set (ANAM4, version 4; Vista Life Science, Norman, OK, USA). 11 tests will be selected, reflecting the three main cognitive functions - memory, attention and executive function. 11 tests: Procedural RT, Memory search, Spatial processing simultaneous, Matching grids, Matching to sample, Stroop colour word test, Code substitution-learning and Code substitution-delayed, Running memory continuous performance, Continous performance test - traditional. To assess cognitive performance, during a simulated 8-hour mental work day, the subjects will complete a set of cognitive tests 8 times (1 session approximately 45 minutes), after each session there will be a break of approximately 10 minutes. Participants were familiarized with the test battery twice before the experiments.

    Measured: Day 1 in 3 different conditions, in 1 condition 8 times for 45 minutes.

  5. Blood pressure (mmHg)

    Systolic and diastolic blood pressure (in mmHg) will be measured using a blood pressure monitor (Biolight, Patient Monitor S10, Guangdong Biolight Meditech Co, Hamburg, Germany).

    Measured: 11 times during 1 condition (total 33 times).

  6. Heart rate and heart rate variability (ms)

    Heart rate (HR) will be recorded using a heart rate monitor (Polar H10, Kempele, Finland) with an electrode strap around the chest throughout the study. 5-min RR interval file will then be analyzed using Kubios HR Variability Analysis Software 2.0 (Biomedical Signal and Medical Image Analysis Group, Department of Applied Physics, University of Kuopio, Kuopio, Finland).

    Measured: During 1 condition rest measurements in the morning, during brain hemodynamic response (3 times during 1 condition), during every session of 8 hours simultaneous mental work day, total 3 conditions.

  7. Glucose level (mmol/l)

    Glucose level will be measured from capillary blood using Akray glucose analyzer (CONTOUR®PLUS ELITE; Basel, Switzerland). Capillary blood samples will be taken by a qualified medical professional (general practice nurse) at the LSU Institute of Sports Science and Innovation laboratory.

    Measured: 9 times during 1 condition (total 27 times).

  8. Ketones level (mmol/L)

    Ketones level will be measured from capillary blood using a ketone analyzer (The On Call® GK Dual; San Diego, CA; USA). Capillary blood samples will be taken by a qualified medical professional (general practice nurse) at the LSU Institute of Sports Science and Innovation laboratory.

    Measured: 9 times during 1 condition (total 27 times).

  9. Lactate level (mmol/L)

    Lactate levels will be measured using a lactate analyzer (Lactatte Pro 2, Arkray, Koji Konan-cho, Koka-shi, Japan). Capillary blood samples will be taken by a qualified medical professional (general practice nurse) at the LSU Institute of Sports Science and Innovation laboratory.

    Measured: 9 times during 1 condition (total 27 times).

  10. Salivary cortisol concentration (µg/dl)

    The saliva samples will be collected to measure cortisol level (in µg/dl) using an ELISA kits and a Spark multimode microplate reader (Tecan, Austria).

    Measured: 11 times during 1 condition (total 33 times).

  11. Salivary testosterone concentration (µg/dl)

    The saliva samples will be collected to measure cortisol level (in µg/dl) using an ELISA kits and a Spark multimode microplate reader (Tecan, Austria).

    Measured: 11 times during 1 condition (total 33 times).

  12. Salivary female sex hormones concentration (pgmol/L)

    The saliva samples will be collected to measure cortisol level (in µg/dl) using an ELISA kits and a Spark multimode microplate reader (Tecan, Austria).

    Measured: 11 times during 1 condition (total 33 times).

  13. Biochemical urine analysis

    The urine sample will be analyzed in the laboratory using a urine analyzer (PocketChem UA, PU-4010, Arkray, Koji, Konan-cho, Koka-shi, Japan). The analyzer will determine the concentrations of ketones.

    Measured: 2 times during 1 condition (total 6 times).

  14. Pupil diameter (mm)

    The dilation and contraction of the pupils of the test subjects' eyes will be recorded using a special camera (Gazepoint, Vancouver, Canada), which will be placed under the computer screen, in front of the subject.

    Measured: Before and 3 times during simulated 8 hours workday in 1 condition (total 12 times).

  15. The psycho-emotional state: Dundee Stress State Questionnaire (DSSQ)

    The psycho-emotional state of the subjects will be assessed using the Dundee Stress State Questionnaire (DSSQ). The DSSQ questionnaire will be used to assess the subjects' motivation in relation to the content of the task, performing a cognitive test battery during the mental work day. 15 questions will be used, e.g.: "the content of the task was interesting", "I wanted to do the task well compared to others", etc. The subject will have to mark the corresponding answers to each question, where 4 (strongly), 3 (very), 2 (a little), 1 (a little), 0 (not at all).

    Measured: Before and 8 times during simulated 8 hours workday in 1 condition (total 27 times).

  16. The psycho-emotional state: the VAS scale

    Motivation, mental fatigue and mind wondering will be assessed using a visual analogue scale (VAS). Subjects will mark their feelings on a 10 centimetres horizontal line from 0 ("completely unmotivated"; "not mentally tired"; "no mind wandering") to 100 ("maximum motivated"; "maximum mental fatigue"; "maximum mind wandering").

    Measured: Before and 8 times during simulated 8 hours workday in 1 condition (total 27 times).

  17. The psycho-emotional state: Stanford sleepiness scale.

    The Stanford Sleepiness Scale will be used to assess subjects' sleepiness. On this scale, subjects will mark their level of sleepiness from 1 "I feel active, efficient, lively, alert or awake" to 7 "I can no longer fight sleep, I will fall asleep quickly; thoughts are like dreams".

    Measured: Before and 8 times during simulated 8 hours workday in 1 condition (total 27 times).

  18. Measurement of maximal aerobic capacity

    The maximal aerobic capacity of the subjects will be measured in order to determine the average aerobic load, which will be applied in the study condition "aerobic activity ". The subjects will perform a consistently increasing load until complete fatigue on a bicycle ergometer (Lode B.V., Excalibur Sport, Groningen, Netherlands). Throughout the test, subjects will have their heart rate monitored using a chest strap heart rate monitor (Polar H10, Kempele, Finland). A spirometry system (Metalyzer 3B, Cortex, Leipzig, Germany) will be used to measure oxygen uptake (VO2). VO2max (maximum oxygen uptake) will be considered the highest oxygen uptake during any 15 s of exercise.

    Measured: Before.

  19. Sleep quality assessment

    Sleep (hours of total sleep and sleep stages) will be monitored using a Garmin wrist-worn watch (Vivo fit 4, UK).

    Measured: 3 days before each condition and during testings.

  20. Physical activity assessment

    Physical activity (steps per day) will be monitored using a Garmin wrist-worn watch (Vivo fit 4, UK).

    Measured: 3 days before each condition and during testings.

  21. Biochemical urine analysis

    The urine sample will be analyzed in the laboratory using a urine analyzer (PocketChem UA, PU-4010, Arkray, Koji, Konan-cho, Koka-shi, Japan). The analyzer will determine the concentrations of leukocytes.

    Measured: 2 times during 1 condition (total 6 times).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start1 Aug 2025
  3. Primary completion1 Mar 2031 (estimated)
  4. Study completion1 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07130825
Sponsor's protocol ID
LithuananianSportsU-23
Status last verified
Aug 2025
First submitted
3 Apr 2025
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 8 hours simulated mental workday, Moderate intensity aerobic activity and Combined work model in people with Healthy Adults, run by Lithuanian Sports University at 1 site in Lithuania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marius Brazaitis, professor (+37067059637, marius.brazaitis@lsu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body mass and body composition (kg) (time frame: 2 times in the mornings (day 1 and day 2) of each 3 conditions.). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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