NCT07453043

Brief 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 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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 10, 2026

Last Update Submit

February 27, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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: 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

    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

    Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest

Study Arms (2)

MEx

EXPERIMENTAL
Other: maximal exercise

Con

NO INTERVENTION

Interventions

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.

MEx

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Physical Education, 31-571 Kraków, Poland

Krakow, 31-572, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

February 10, 2026

First Posted

March 5, 2026

Study Start

November 20, 2024

Primary Completion

January 9, 2025

Study Completion

January 9, 2025

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations