NCT07130825

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
59mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Aug 2025Mar 2031

First Submitted

Initial submission to the registry

April 3, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

5.6 years

First QC Date

April 3, 2025

Last Update Submit

August 18, 2025

Conditions

Outcome Measures

Primary Outcomes (21)

  • Body mass and body composition (kg)

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

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

  • Height (m)

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

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

  • 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.

    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.

  • 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.

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

  • 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).

    11 times during 1 condition (total 33 times).

  • 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).

    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.

  • 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.

    9 times during 1 condition (total 27 times).

  • 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.

    9 times during 1 condition (total 27 times).

  • 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.

    9 times during 1 condition (total 27 times).

  • 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).

    11 times during 1 condition (total 33 times).

  • 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).

    11 times during 1 condition (total 33 times).

  • 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).

    11 times during 1 condition (total 33 times).

  • 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.

    2 times during 1 condition (total 6 times).

  • 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.

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

  • 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).

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

  • 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").

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

  • 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".

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

  • 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.

    Before.

  • Sleep quality assessment

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

    3 days before each condition and during testings.

  • Physical activity assessment

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

    3 days before each condition and during testings.

  • 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.

    2 times during 1 condition (total 6 times).

Study Arms (3)

Control

EXPERIMENTAL

Healthy 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).

Other: 8 hours simulated mental workday

Aerobic activity

EXPERIMENTAL

Healthy 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).

Other: 8 hours simulated mental workdayOther: Moderate intensity aerobic activity

Combined work model

EXPERIMENTAL

Healthy 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).

Other: 8 hours simulated mental workdayOther: Combined work model

Interventions

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.

Aerobic activityCombined work modelControl

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.

Aerobic activity

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).

Combined work model

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sport Science and Innovations

Kaunas, Lithuania

RECRUITING

Central Study Contacts

Marius Brazaitis, professor

CONTACT

Aura Mažuolytė-Binderienė

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2025

First Posted

August 19, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations