HealthyIEISMNCT06201052
Impact of Exercise on Immune System and Metabolism in Football Players
An observational study of Healthy, run by Poznan University of Physical Education at 1 site in Poland.
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'… Read more about this study
- Who is it for?
- Ages 22 to 37 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise test
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2017to 15 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 37 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Competitive football training for at least 3 years
- Male
- Not taking any medications throughout the study
- Provide voluntary consent for participation in the study
Who cannot join
- Any healthy problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Physical Exercise on Chosen Parameters of the Immune System, Prooxidant-Antioxidant Balance, and Iron Metabolism in Football Players With Various Training Levels
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:
- How do athletes' experience and training background influence the immune system's response, pro-antioxidant balance, and iron regulation?
- 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?"
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- Exercise test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise testOther
Beep Test for measuring aerobic power
| Study group | Role | What they receive |
|---|---|---|
| Junior | Junior soccer players 19 male, average training experience: 8 years Receives: Other: Exercise test | |
| Senior | Senior Soccer players 21 male, average training experience: 16 years Receives: Other: Exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in iron level
marker of iron management
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Feb 2017
- Primary completion10 May 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Nicolaus Copernicus University
- Responsible party
- Principal investigator, Joanna Ostapiuk-Karolczuk, Poznan University of Physical Education
- Investigators
- Joanna Ostapiuk-Karolczuk, Ph.D., Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201052
- Sponsor's protocol ID
- 382/2017
- Acronym
- IEISM
- Status last verified
- Jul 2024
- First submitted
- 30 Dec 2023
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Physical Exercise on Chosen Parameters of the Immune System, Prooxidant-Antioxidant Balance, and Iron Metabolism in Football Players With Various Training Levels
- ClinicalTrials.gov ID
- NCT06201052
- Acronym / sponsor ID
- IEISM / 382/2017
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Collaborators
- Nicolaus Copernicus University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How do athletes' experience and training background influence the immune system's response, pro-antioxidant balance, and iron regulation?
- 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?"
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Junior | – | Other: Exercise testJunior soccer players 19 male, average training experience: 8 years |
| Senior | – | Other: Exercise testSenior Soccer players 21 male, average training experience: 16 years |
Who may qualify
- Ages
- 22 to 37 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Competitive football training for at least 3 years
- Male
- Not taking any medications throughout the study
- Provide voluntary consent for participation in the study
Key exclusion criteria (1 listed)
- Any healthy problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise testBeep Test for measuring aerobic power | Other | Junior, Senior |
Primary outcome
Changes in iron level
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of iron management
Changes in UIBC (unsaturated iron-binding capacity)
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of iron management
Changes in TIBC (total iron-binding capacity)
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of iron management
Changes in hepcidin
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of iron management
Changes in lactoferrin
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of iron management
Changes in IL-6 (interleukin-6)
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of immune system
Changes in IL-10 (interleukin-10)
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of immune system
Changes in TNF-α (tumor necrosis factor-alpha)
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of immune response
Changes in tryptophan
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of immune response
Changes in IGF-1 (insulin-like growth factor 1)
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of hormonal response
Changes in testosterone
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of hormonal response
Changes in cortisol
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of hormonal response
Changes in serotonin
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of neurohormonal response
Changes in myoglobin
Time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.
marker of muscle damage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Ostapiuk-Karolczuk, Ph.D. principal investigator
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in iron level (time frame: At rest (before the exercise test), 1 minute after the end of the test, after 3 hours, and 24 hours of recovery.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.