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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06201052
Other study ID # 382/2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date November 15, 2018

Study information

Verified date December 2023
Source Poznan University of Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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. How do athletes' experience and training background influence the immune system's response, pro-antioxidant balance, and iron regulation? 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?"


Description:

The study included 40 football players (19 juniors and 21 seniors). The average training experience for junior players was 8.37 years, and for the senior group, it was 16.4 years. All athletes underwent the Multistage 20-meter shuttle run test (Beep Test). Players were informed about the test procedures and additionally motivated by the trainer to exert maximum effort. Each attempt was preceded by a warm-up, consisting of a 5-minute low-intensity jog. The Beep Test was supervised by the Team trainer using a program as a monitoring tool to examine changes in the level of cardio-respiratory fitness across all age groups. Blood samples were collected at rest, before the exercise test, then 1 minute after the end of the exercise test, after 3 hours of recovery, and finally, after 24 hours. Blood was drawn from the antecubital vein, with 12 ml collected each time.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 15, 2018
Est. primary completion date May 10, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 22 Years to 37 Years
Eligibility Inclusion Criteria: - Competitive football training for at least 3 years - Male - Not taking any medications throughout the study - Provide voluntary consent for participation in the study Exclusion Criteria: - Any healthy problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise test
Beep Test for measuring aerobic power

Locations

Country Name City State
Poland Poznan University of Physical Education Poznan

Sponsors (2)

Lead Sponsor Collaborator
Poznan University of Physical Education Nicolaus Copernicus University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary Changes in UIBC 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.
Primary Changes in TIBC 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.
Primary 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.
Primary 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.
Primary Changes in IL-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.
Primary Changes in IL-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.
Primary Changes in TNF-a 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.
Primary 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.
Primary Changes in IGF-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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
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