NCT06201052

Brief Summary

Physical exercise, especially of high intensity, is a significant burden to the athlete's body. It should be emphasized that achieving high results in competitive sports requires significant, sometimes extreme, exercise loads during training, which may result in homeostasis disorders, adversely affecting athletes' fitness. Intense and prolonged physical exercise elevates reactive oxygen species, potentially impacting immune function. The mechanism, particularly in high-intensity activities, remains incompletely understood. Excessive oxygen radicals may induce metabolic changes, causing rapid erythrocyte damage and elevated redox-active free iron. This iron increase can be harmful, increasing oxidative stress and immune system activation. The sustained negative impact that may be observed even during post-workout recovery needs further exploration. "This study aims to explain the impact of an intense exercise test on the immune system, pro-antioxidant balance, and iron metabolism in athletes with varying training levels. The primary questions it seeks to address are:

  1. 1.How do athletes' experience and training background influence the immune system's response, pro-antioxidant balance, and iron regulation?
  2. 2.Can the level of adaptation to physical exercise (training status) affect the rate of regeneration and the time required to return to pre-exercise homeostasis?"

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

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

February 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

December 30, 2023

Last Update Submit

July 8, 2024

Conditions

Outcome Measures

Primary Outcomes (14)

  • Changes in iron level

    marker of iron management

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in UIBC (unsaturated iron-binding capacity)

    marker of iron management

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in TIBC (total iron-binding capacity)

    marker of iron management

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in hepcidin

    marker of iron management

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in lactoferrin

    marker of iron management

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in IL-6 (interleukin-6)

    marker of immune system

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in IL-10 (interleukin-10)

    marker of immune system

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in TNF-α (tumor necrosis factor-alpha)

    marker of immune response

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in tryptophan

    marker of immune response

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in IGF-1 (insulin-like growth factor 1)

    marker of hormonal response

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in testosterone

    marker of hormonal response

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in cortisol

    marker of hormonal response

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in serotonin

    marker of neurohormonal response

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

  • Changes in myoglobin

    marker of muscle damage

    At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.

Study Arms (2)

Junior

Junior soccer players 19 male, average training experience: 8 years

Other: Exercise test

Senior

Senior Soccer players 21 male, average training experience: 16 years

Other: Exercise test

Interventions

Beep Test for measuring aerobic power

JuniorSenior

Eligibility Criteria

Age22 Years - 37 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Forty healthy football players, aged from 22 to 37 years. The average training experience for junior players was 8 years and 16 for the senior group.

You may qualify if:

  • Competitive football training for at least 3 years
  • Male
  • Not taking any medications throughout the study
  • Provide voluntary consent for participation in the study

You may not qualify if:

  • Any healthy problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznań University of Physical Education

Poznan, 61-871, Poland

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Joanna Ostapiuk-Karolczuk, Ph.D.

    Poznan University of Physical Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 30, 2023

First Posted

January 11, 2024

Study Start

February 1, 2017

Primary Completion

May 10, 2018

Study Completion

November 15, 2018

Last Updated

July 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations