Exhaustion - PhysiologicalETTETTSIAMARNCT06844968
The Effect of a 2000-m Ergometer Test on Training Status Indicators and the Muscle Adaptation in Rowers
A study testing Physical effort in people with Exhaustion - Physiological, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
Intense physical exercise can lead to micro-damage to tissues and activation of inflammatory processes, the body's natural response to exercise-related metabolic stress. Monitoring inflammation and fatigue will enable the observation of athletes in terms of post-exercise regeneration and muscle adaptation to physical… Read more about this study
- Who is it for?
- Ages 19 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Exhaustion - Physiological
- What is being tested?
- Physical effort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2024to 30 Nov 2024
- Phase
- Interventional
- 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 19 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- members of the Polish Youth Rowing Team - competitors officially called up to the Polish national rowing team,
- no musculoskeletal injuries that would prevent them from performing the exercise test,
- written consent of the competitor to participate in the study.
Who cannot join
- anti-inflammatory drugs, other supplements in the last 3 months before starting the study,
- failure to complete the test,
- current injury, post-traumatic condition, illness,
- lack of informed consent of the athlete.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznań University of Physical Education, Faculty of Physical Culture in Gorzów Wielkopolski
Gorzów Wielkopolski, Polska, 66-400
About this study
Official title: Multi-Faced Optimization of Sports Training Focused on Training Status Energy and Muscle Adaptation to Effort
Intense physical exercise can lead to micro-damage to tissues and activation of inflammatory processes, the body's natural response to exercise-related metabolic stress. Monitoring inflammation and fatigue will enable the observation of athletes in terms of post-exercise regeneration and muscle adaptation to physical effort. The obtained results will allow for estimating the level of fatigue, minimizing the risk of injury, and will show the rate of post-exercise regeneration or its absence.
Read the detailed description
The study will involve 40 members of the Polish Youth Rowing Team, both sexes, aged 19-23. The study will be held on three dates related to the specifics of the athletes' training cycle, i.e. in the preparatory period (March), the competition period (June), and the detraining period (November). The participants will perform an intensive exercise test on a rowing ergometer (manufacturer: Concept II, USA), covering a distance of 2,000 meters in the shortest possible time. The study will involve 40 members of the Polish Youth Rowing Team, both sexes, aged 19-23. Each time, before starting the exercise test, a non-invasive anthropometric analysis will be performed using the TANITA MC-780MA body composition analyzer (tanita Japan), to determine the body composition: percentage of body fat, body fat mass, lean tissue mass, muscle mass, body water and body mass index (BMI). On the three indicated dates, before and after the stress test, capillary blood (ear lobe) from the cubital vein will be collected from the participants. Using immunoenzymatic ELISA tests, the following will be determined: EPO (erythropoietin), VEGF (vascular endothelial growth factor), CRP (C-reactive protein), glycogen, hypoxanthine (Hx). Glucose level will be determined using an Accu-Chek Active glucometer (Roche, Germany).
- Conditions
- Exhaustion - Physiological
- Being tested
- Physical effort
- Keywords
- rowers, EPO, VEGF, hypoxanthine, glycogen, athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical effortOther
Also called Rowing ergometer test
The examined rowers will be subjected to an effort on a rowing ergometer, consisting of covering a designated distance in the shortest possible time.
| Study group | Role | What they receive |
|---|---|---|
| Physical effort | Other | The effort on the rowing ergometer, based on swimming a specified distance in the shortest possible time. Receives: Other: Physical effort |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPO (erythropoietin) level
Immunoenzymatic assay method using a diagnostic ELISA Kit
Measured: Immediately before the ergometer test, immediately after and 3 hours after the test
VEGF (vascular endothelial growth factor) level
Immunoenzymatic assay method using a diagnostic ELISA Kit
Measured: Immediately before the ergometer test, immediately after and 3 hours after the test
Hypoxanthine (Hx) level
Immunoenzymatic assay method using a diagnostic ELISA Kit
Measured: Immediately before the ergometer test, immediately after and 3 hours after the test
Glycogen level
Immunoenzymatic assay method using a diagnostic ELISA Kit
Measured: Immediately before the ergometer test, immediately after and 3 hours after the test
Glucose level
Using an Accu-Chek Active glucometer (Roche, Germany)
Measured: Immediately before the ergometer test, immediately after and 3 hours after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exhaustion - PhysiologicalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A group of rowers subjected to an efford on a rowing ergometer. The examined rowers group will be subjected to an effort on a rowing ergometer, consisting of covering a designated distance in the shortest possible time.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Kasperska, PhD, Principal investigator, Poznań University of Physical Education, Faculty of Sport Sciences in Gorzów Wielkopolski, Poland;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844968
- Sponsor's protocol ID
- Rowers 2024
- Other IDs
- RPW/8857/2024
- Acronym
- ETTETTSIAMAR
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Faced Optimization of Sports Training Focused on Training Status Energy and Muscle Adaptation to Effort
- ClinicalTrials.gov ID
- NCT06844968
- Acronym / sponsor ID
- ETTETTSIAMAR / Rowers 2024
- Conditions
- Exhaustion - Physiological
- Keywords
- rowers, EPO, VEGF, hypoxanthine, glycogen, athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 25 Feb 2025 (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.
Intense physical exercise can lead to micro-damage to tissues and activation of inflammatory processes, the body's natural response to exercise-related metabolic stress. Monitoring inflammation and fatigue will enable the observation of athletes in terms of post-exercise regeneration and muscle adaptation to physical effort. The obtained results will allow for estimating the level of fatigue, minimizing the risk of injury, and will show the rate of post-exercise regeneration or its absence.
Detailed description
The study will involve 40 members of the Polish Youth Rowing Team, both sexes, aged 19-23. The study will be held on three dates related to the specifics of the athletes' training cycle, i.e. in the preparatory period (March), the competition period (June), and the detraining period (November). The participants will perform an intensive exercise test on a rowing ergometer (manufacturer: Concept II, USA), covering a distance of 2,000 meters in the shortest possible time. The study will involve 40 members of the Polish Youth Rowing Team, both sexes, aged 19-23. Each time, before starting the exercise test, a non-invasive anthropometric analysis will be performed using the TANITA MC-780MA body composition analyzer (tanita Japan), to determine the body composition: percentage of body fat, body fat mass, lean tissue mass, muscle mass, body water and body mass index (BMI). On the three indicated dates, before and after the stress test, capillary blood (ear lobe) from the cubital vein will be collected from the participants. Using immunoenzymatic ELISA tests, the following will be determined: EPO (erythropoietin), VEGF (vascular endothelial growth factor), CRP (C-reactive protein), glycogen, hypoxanthine (Hx). Glucose level will be determined using an Accu-Chek Active glucometer (Roche, Germany).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A group of rowers subjected to an efford on a rowing ergometer. The examined rowers group will be subjected to an effort on a rowing ergometer, consisting of covering a designated distance in the shortest possible time.
| Arm | Type | Receives |
|---|---|---|
| Physical effort | Other | Other: Physical effortThe effort on the rowing ergometer, based on swimming a specified distance in the shortest possible time. |
Who may qualify
- Ages
- 19 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- members of the Polish Youth Rowing Team - competitors officially called up to the Polish national rowing team,
- no musculoskeletal injuries that would prevent them from performing the exercise test,
- written consent of the competitor to participate in the study.
Key exclusion criteria (4 listed)
- anti-inflammatory drugs, other supplements in the last 3 months before starting the study,
- failure to complete the test,
- current injury, post-traumatic condition, illness,
- lack of informed consent of the athlete.
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 |
|---|---|---|
| Physical effortAlso: Rowing ergometer testThe examined rowers will be subjected to an effort on a rowing ergometer, consisting of covering a designated distance in the shortest possible time. | Other | Physical effort |
Primary outcome
EPO (erythropoietin) level
Time frame: Immediately before the ergometer test, immediately after and 3 hours after the test
Immunoenzymatic assay method using a diagnostic ELISA Kit
VEGF (vascular endothelial growth factor) level
Time frame: Immediately before the ergometer test, immediately after and 3 hours after the test
Immunoenzymatic assay method using a diagnostic ELISA Kit
Hypoxanthine (Hx) level
Time frame: Immediately before the ergometer test, immediately after and 3 hours after the test
Immunoenzymatic assay method using a diagnostic ELISA Kit
Glycogen level
Time frame: Immediately before the ergometer test, immediately after and 3 hours after the test
Immunoenzymatic assay method using a diagnostic ELISA Kit
Glucose level
Time frame: Immediately before the ergometer test, immediately after and 3 hours after the test
Using an Accu-Chek Active glucometer (Roche, Germany)
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 25 Feb 2025.
- Individual participant dataSharing planned: No
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.
Anna Kasperska, PhD principal investigator
Poznań University of Physical Education, Faculty of Sport Sciences in Gorzów Wielkopolski, Poland;
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical effort in people with Exhaustion - Physiological, 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 3 inclusion and 4 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 25 Feb 2025. 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?
EPO (erythropoietin) level (time frame: Immediately before the ergometer test, immediately after and 3 hours after the test). The study lists 5 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 25 Feb 2025.