Basic ScienceNCT07453043
Acute Effects of Maximal Exercise on Balance and Cognitive Domains in Young Men
A study testing maximal exercise in people with Basic Science, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
Trial summary
The project involves conducting a series of motor, physiological, biochemical, and psychological tests. The series of tests within the experiment will assess the effect of a single aerobic exercise (graded test) on changes in sensory organization and balance performance (based on the SOT test conducted on the Smart… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Basic Science
- What is being tested?
- maximal exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 20 Nov 2024to 9 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good health
- No orthopedic injuries in the limbs (ankle and knee joints)
- Ability to perform intense physical exercise
Who cannot join
- Obesity and overweight
- Chronic diseases
- Injuries suffered within 6 months before the start of the project
- Training in any sports discipline
Trial locations and contacts
1 site in 1 country.
Poland1 site
University of Physical Education, 31-571 Kraków, Poland
Krakow, 31-572
About this study
The project involves conducting a series of motor, physiological, biochemical, and psychological tests.
The series of tests within the experiment will assess the effect of a single aerobic exercise (graded test) on changes in sensory organization and balance performance (based on the SOT test conducted on the Smart Balancemaster dynamic computerized posturography platform from Neurocom, USA) as well as cognitive functions in the Go/No-Go and Stroop tasks.
Read more
Research Design:
The study will be conducted in two rounds, each repeating the following design. Participants from both groups will complete cognitive tests, including the SOT sensory organization test. The first group will then undergo exercise (graded test), followed by a repeat of the SOT and cognitive tests. The second group will complete only the repeated SOT and cognitive tests. In the second round of testing, the design will be reversed for the groups.
In groups that will perform the exercise test in a given series, blood will be collected three times to assess lactate concentration.
The aim of the experiments will be to answer the fundamental question:
To what extent do external factors disrupt or modify the sensory organization of balance and the efficiency of this process?
What impact can cognitive impairments have on this process?
Achieving this goal will require answering a number of specific questions:
- To what extent does aerobic exercise affect sensory organization and the efficiency of balance?
- To what extent does aerobic exercise affect cognitive functions, and to what extent does impairment in these functions affect sensory organization and the efficiency of balance?
- Conditions
- Basic Science
- Being tested
- maximal exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maximal exerciseOther
Graded Exercise. The goal of the exercise was to bring the participant to maximum intensity. The test was performed on a cycle ergometer using a ramp protocol.
| Study group | Role | What they receive |
|---|---|---|
| MEx | Experimental | Not described Receives: Other: maximal exercise |
| Con | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory analysis
Sensory organization (sensory integration; multi-sensory organization) is the ability of an individual to effectively process individual sensory system input cues to maintain balance control. This is done by suppressing inaccurate sensory system inputs while selecting appropriately from other, more accurate sensory cues to generate appropriate motor and postural response strategies. The Sensory Organization Test, systematically assesses this ability, objectively isolating and quantifying the use of each sensory system and the adaptive (or maladaptive) responses of the central nervous system. It is calculated as a ratio of Equilibrium scores.
The result is expressed as an inverse percentage between 0 and 100.
Measured: Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
Balance Strategy
The relative use of movement about the ankle, hips and upper body to maintain balance during the SOT is reflected in the strategy scores. Shear forces are exerted against the support surface whenever the body's COG accelerates in the horizontal direction. Sway movements about the ankle are confined to low frequencies (below 0.5 Hz), the resulting COG accelerations and shear are small. Hip movements are typically fast (1 Hz and above) and therefore, generate larger shear forces which are also higher in frequency. Strategy scores are calculated by comparing the peak-to-peak amplitude of the shear oscillation to the maximum possible shear of 25 pounds (11.4 kg). This comparison is expressed as a percentage, with scores near 100 indicating little, if any, shear (i.e. full ankle strategy), while scores approaching zero indicate maximum shear (i.e. full hip strategy). All data describing the displacement of the center of gravity were recorded on a stilometric platform.
Measured: Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
Equilibrium scores
The equilibrium score for each trial is calculated by comparing the angular difference between the patient's maximum anterior to posterior COG displacements to this theoretical maximum displacement. All data describing the displacement of the center of gravity were recorded on a stilometric platform. The result is expressed as an inverse percentage between 0 and 100. Scores approaching 0 indicate sway amplitudes approaching the limits of stability with a value of 100 indicating perfect stability. A score of 0 indicates that the patient "fell" on that trial.
The SOT consists of six trials:
- Test on a stationary platform with eyes open,
- Test on a stationary platform with eyes closed,
- Test on a stationary platform with eyes open, but moving surroundings,
- Test on a moving platform, stationary surroundings, with eyes open,
- Examination on a moving platform with eyes closed
- Examination on a moving platform with eyes open a moving environment
Measured: Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
Stroop Test
Accuracy and reaction times were recorded for all trials. Reaction times (RTs) and response accuracy were calculated separately for congruent and incongruent trials. Accuracy was defined as the proportion of correct responses within each condition. RT analyses were restricted to correct trials only
Measured: Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start20 Nov 2024
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basic ScienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Przemysław Bujas, University School of Physical Education, Krakow, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453043
- Sponsor's protocol ID
- RID/SP/0027/2024/01
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Maximal Exercise on Balance and Cognitive Domains in Young Men
- ClinicalTrials.gov ID
- NCT07453043
- Acronym / sponsor ID
- RID/SP/0027/2024/01
- Conditions
- Basic Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project involves conducting a series of motor, physiological, biochemical, and psychological tests.
The series of tests within the experiment will assess the effect of a single aerobic exercise (graded test) on changes in sensory organization and balance performance (based on the SOT test conducted on the Smart Balancemaster dynamic computerized posturography platform from Neurocom, USA) as well as cognitive functions in the Go/No-Go and Stroop tasks.
Research Design:
The study will be conducted in two rounds, each repeating the following design. Participants from both groups will complete cognitive tests, including the SOT sensory organization test. The first group will then undergo exercise (graded test), followed by a repeat of the SOT and cognitive tests. The second group will complete only the repeated SOT and cognitive tests. In the second round of testing, the design will be reversed for the groups.
In groups that will perform the exercise test in a given series, blood will be collected three times to assess lactate concentration.
The aim of the experiments will be to answer the fundamental question:
To what extent do external factors disrupt or modify the sensory organization of balance and the efficiency of this process?
What impact can cognitive impairments have on this process?
Achieving this goal will require answering a number of specific questions:
- To what extent does aerobic exercise affect sensory organization and the efficiency of balance?
- To what extent does aerobic exercise affect cognitive functions, and to what extent does impairment in these functions affect sensory organization and the efficiency of balance?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEx | Experimental | Other: maximal exercise |
| Con | No intervention | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good health
- No orthopedic injuries in the limbs (ankle and knee joints)
- Ability to perform intense physical exercise
Key exclusion criteria (4 listed)
- Obesity and overweight
- Chronic diseases
- Injuries suffered within 6 months before the start of the project
- Training in any sports discipline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maximal exerciseGraded Exercise. The goal of the exercise was to bring the participant to maximum intensity. The test was performed on a cycle ergometer using a ramp protocol. | Other | MEx |
Primary outcome
Sensory analysis
Time frame: Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
Sensory organization (sensory integration; multi-sensory organization) is the ability of an individual to effectively process individual sensory system input cues to maintain balance control. This is done by suppressing inaccurate sensory system inputs while selecting appropriately from other, more accurate sensory cues to generate appropriate motor and postural response strategies. The Sensory Organization Test, systematically assesses this ability, objectively isolating and quantifying the use of each sensory system and the adaptive (or maladaptive) responses of the central nervous system. It is calculated as a ratio of Equilibrium scores. The result is expressed as an inverse percentage between 0 and 100.
Balance Strategy
Time frame: Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
The relative use of movement about the ankle, hips and upper body to maintain balance during the SOT is reflected in the strategy scores. Shear forces are exerted against the support surface whenever the body's COG accelerates in the horizontal direction. Sway movements about the ankle are confined to low frequencies (below 0.5 Hz), the resulting COG accelerations and shear are small. Hip movements are typically fast (1 Hz and above) and therefore, generate larger shear forces which are also higher in frequency. Strategy scores are calculated by comparing the peak-to-peak amplitude of the shear oscillation to the maximum possible shear of 25 pounds (11.4 kg). This comparison is expressed as a percentage, with scores near 100 indicating little, if any, shear (i.e. full ankle strategy), while scores approaching zero indicate maximum shear (i.e. full hip strategy). All data describing the displacement of the center of gravity were recorded on a stilometric platform.
Equilibrium scores
Time frame: Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
The equilibrium score for each trial is calculated by comparing the angular difference between the patient's maximum anterior to posterior COG displacements to this theoretical maximum displacement. All data describing the displacement of the center of gravity were recorded on a stilometric platform. The result is expressed as an inverse percentage between 0 and 100. Scores approaching 0 indicate sway amplitudes approaching the limits of stability with a value of 100 indicating perfect stability. A score of 0 indicates that the patient "fell" on that trial. The SOT consists of six trials: 1. Test on a stationary platform with eyes open, 2. Test on a stationary platform with eyes closed, 3. Test on a stationary platform with eyes open, but moving surroundings, 4. Test on a moving platform, stationary surroundings, with eyes open, 5. Examination on a moving platform with eyes closed 6. Examination on a moving platform with eyes open a moving environment
Stroop Test
Time frame: Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
Accuracy and reaction times were recorded for all trials. Reaction times (RTs) and response accuracy were calculated separately for congruent and incongruent trials. Accuracy was defined as the proportion of correct responses within each condition. RT analyses were restricted to correct trials only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maximal exercise in people with Basic Science, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 Mar 2026. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory analysis (time frame: Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest). The study lists 4 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 5 Mar 2026.