- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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?
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Krakow, Poland, 31-572
- University of Physical Education, 31-571 Kraków, Poland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MEx
|
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.
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|
No Intervention: Con
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
|
|
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.
|
Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
|
|
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:
|
Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
|
|
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
|
Change from baseline to 20 minutes after intervention or after 20 minutes of passive rest
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RID/SP/0027/2024/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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