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Completed

NCT Number: NCT07453043

Acute Effects of Maximal Exercise on Balance and Cognitive Domains in Young Men

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?

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Key information

Conditions

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Physical Education, 31-571 Kraków, Poland

Krakow, 31-572, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Good health
  • No orthopedic injuries in the limbs (ankle and knee joints)
  • Ability to perform intense physical exercise

Exclusion criteria

  • Obesity and overweight
  • Chronic diseases
  • Injuries suffered within 6 months before the start of the project
  • Training in any sports discipline

Treatment and study plan

maximal exercise

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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:

    • 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
  4. 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

Sponsors and collaborators

Lead sponsor

University School of Physical Education, Krakow, Poland

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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