Performance Enhancing Product UseNCT06112210
Effect of Hyperbaric Oxygen Therapy
A study testing HBOT group and CON group in people with Performance Enhancing Product Use and Physical Fitness, run by University Medical Centre Ljubljana at 1 site in Serbia.
Trial summary
The goal of this tudy will be to investigate the effects of a single session of hyperbaric oxygen therapy (HBOT) on recovery and performance after a football match in elite youth football players. Read more about this study
- Who is it for?
- Ages 16 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Performance Enhancing Product Use, Physical Fitness, Recovery
- What is being tested?
- HBOT group and CON group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSerbia
- Study dates
- 20 May 2023to 6 Jun 2023
- 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 16 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- football player
- free of injuries
- free of medical conditions contraindicated by hyperbaric oxygen therapy (HBOT)
- written parental consent
Who cannot join
- pre-existing injuries or medical conditions that are contraindicated by hyperbaric oxygen therapy (HBOT)
- participation in severe physical activity within 24 hours before the study
- participants who do not comply with the requirement to abstain from breakfast, caffeine, and alcohol prior to the first blood collection
- an active respiratory illness, such as a cold, at the time of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hyperbaric Oxygen Therapy Has no Acute Effects on Recovery and Performance After a Football Match
The goal of this tudy will be to investigate the effects of a single session of hyperbaric oxygen therapy (HBOT) on recovery and performance after a football match in elite youth football players.
The main questions this study will aim to answer are:
Read more
Will a single session of HBOT improve recovery parameters such as biochemical markers and physical fitness in elite youth football players after a football match? Will a single session of HBOT enhance the performance of elite youth football players after a football match?
Participants in this study will include twenty elite youth male football players. They will be randomly assigned to either the HBOT group or the control group. All participants will undergo evaluations for biochemical parameters, physical fitness tests, and the Hooper Index (HI) at multiple time points: before the match, at the end of the match, one hour after the HBOT session, and 12 hours after the HBOT session.
In the HBOT group, participants will receive 100% oxygen under elevated pressure in a hyperbaric chamber for a duration of 70 minutes immediately after the football match. Meanwhile, the control group will be exposed to normal atmospheric pressure.
Biochemical analysis will involve collecting blood samples to measure markers such as myoglobin, creatine kinase, lactate dehydrogenase, alanine aminotransferase, and aspartate aminotransferase. Physical fitness tests will include vertical jump height measurements (squat jump, countermovement jump, and countermovement jump with arm swing) and linear speed assessments at various distances (5 m, 10 m, and 20 m). The Hooper Index (HI) will be used for subjective assessment of fatigue and well-being.
This study aims to provide insights into the potential benefits of HBOT as a recovery strategy for elite youth football players and its impact on performance in the future.
- Conditions
- Performance Enhancing Product Use, Physical Fitness, Recovery, Sport
- Being tested
- HBOT group, CON group
- Keywords
- hyperbaric chamber, football, recovery, hyperbaric oxygen therapy, performance, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOT groupOther
The HBOT will be performed in a Barox HBOT chamber (Yaklasim Makina San. Ve Tic. Ltd. Sti). Participants will be taken to the chamber immediately after the football match, where they will sit in individual chairs, and oxygen will be delivered through individual masks. The HBOT group will be exposed to 100% oxygen at 2.2 ATA (atmospheres absolute). Session will last 70 minutes.
CON groupOther
Also called Control, Placebo
The placebo protocols will be performed in a Barox HBOT chamber (Yaklasim Makina San. Ve Tic. Ltd. Sti). Participants will be taken to the chamber immediately after the football match, where they will sit in individual chairs, and oxygen will be delivered through individual masks. The CON group will be exposed to normobaric ambient pressure (1 ATA). The session will last 70 minutes.
| Study group | Role | What they receive |
|---|---|---|
| HBOT group | Experimental | Not described Receives: Other: HBOT group |
| CON group | Placebo comparator | Not described Receives: Other: CON group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myoglobin
Measure of myoglobin concentration in blood. Myoglobin will be determined using Siemens IMMULITE 1000 (Siemens Healthcare Diagnostics, UK).
Measured: baseline, 3 hours, 5 hours, 24 hours
Creatine kinase
Measure of creatine kinase concentration in blood. It will be analyzed using a biochemistry analyzer (A25 Biosystems Chemistry Analyzer).
Measured: baseline, 3 hours, 5 hours, 24 hours
Lactate dehydrogenase
Measure of lactate dehydrogenase concentration in blood. It will be analyzed using a biochemistry analyzer (A25 Biosystems Chemistry Analyzer).
Measured: baseline, 3 hours, 5 hours, 24 hours
Alanine aminotransferase
Measure of alanine aminotransferase concentration in blood. It will be analyzed using a biochemistry analyzer (A25 Biosystems Chemistry Analyzer).
Measured: baseline, 3 hours, 5 hours, 24 hours
Aspartate aminotransferase
Measure of aspartate aminotransferase concentration in blood. It will be analyzed using a biochemistry analyzer (A25 Biosystems Chemistry Analyzer).
Measured: baseline, 3 hours, 5 hours, 24 hours
Secondary outcomes (6)
Squat jump
Measure of a squat jump height in cm. The squat jump will be performed in a semi-squat position with the knees bent at 90 degrees and the arms resting on the hips. Participants will hold this stance for one to three seconds before executing a maximal vertical jump.
Measured: baseline, 3 hours, 5 hours, 24 hours
Countermovement jump
Measure of a countermovement jump height in cm. It will be evaluated with participants standing straight up, distributing their weight equally over both feet. The arms will be secured to the hips to prevent their influence on jump height. Participants will then squat down to a 90-degree flexion and execute a maximal vertical jump without pausing during the change of direction.
Measured: baseline, 3 hours, 5 hours, 24 hours
Countermovement jump with arm swing
Measure of a countermovement jump with arm swing height in cm. It will be evaluated with participants standing straight up, distributing their weight equally over both feet. During the jump, participants will have the freedom to move their arms.
Measured: baseline, 3 hours, 5 hours, 24 hours
5 meter linear speed
Measure of 5 meter linear speed. The Witty photocell system (Witty, System, Microgate, Bolzano, Italy) will be utilized to evaluate performance. These photocells will be positioned 0.4 meters above the ground and will provide measurements with an accuracy of 0.001 meters per second.
Measured: baseline, 3 hours, 5 hours, 24 hours
10 meter linear speed
Measure of 10 meter linear speed. The Witty photocell system (Witty, System, Microgate, Bolzano, Italy) will be utilized to evaluate performance. These photocells will be positioned 0.4 meters above the ground and will provide measurements with an accuracy of 0.001 meters per second.
Measured: baseline, 3 hours, 5 hours, 24 hours
20 meter linear speed
Measure of 20 meter linear speed. The Witty photocell system (Witty, System, Microgate, Bolzano, Italy) will be utilized to evaluate performance. These photocells will be positioned 0.4 meters above the ground and will provide measurements with an accuracy of 0.001 meters per second.
Measured: baseline, 3 hours, 5 hours, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start20 May 2023
- Primary completion4 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance Enhancing Product UseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112210
- Sponsor's protocol ID
- HBstudy
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperbaric Oxygen Therapy Has no Acute Effects on Recovery and Performance After a Football Match
- ClinicalTrials.gov ID
- NCT06112210
- Acronym / sponsor ID
- HBstudy
- Conditions
- Performance Enhancing Product Use, Physical Fitness, Recovery, Sport
- Keywords
- hyperbaric chamber, football, recovery, hyperbaric oxygen therapy, performance, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 1 Nov 2023 (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.
The goal of this tudy will be to investigate the effects of a single session of hyperbaric oxygen therapy (HBOT) on recovery and performance after a football match in elite youth football players.
The main questions this study will aim to answer are:
Will a single session of HBOT improve recovery parameters such as biochemical markers and physical fitness in elite youth football players after a football match? Will a single session of HBOT enhance the performance of elite youth football players after a football match?
Participants in this study will include twenty elite youth male football players. They will be randomly assigned to either the HBOT group or the control group. All participants will undergo evaluations for biochemical parameters, physical fitness tests, and the Hooper Index (HI) at multiple time points: before the match, at the end of the match, one hour after the HBOT session, and 12 hours after the HBOT session.
In the HBOT group, participants will receive 100% oxygen under elevated pressure in a hyperbaric chamber for a duration of 70 minutes immediately after the football match. Meanwhile, the control group will be exposed to normal atmospheric pressure.
Biochemical analysis will involve collecting blood samples to measure markers such as myoglobin, creatine kinase, lactate dehydrogenase, alanine aminotransferase, and aspartate aminotransferase. Physical fitness tests will include vertical jump height measurements (squat jump, countermovement jump, and countermovement jump with arm swing) and linear speed assessments at various distances (5 m, 10 m, and 20 m). The Hooper Index (HI) will be used for subjective assessment of fatigue and well-being.
This study aims to provide insights into the potential benefits of HBOT as a recovery strategy for elite youth football players and its impact on performance in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBOT group | Experimental | Other: HBOT group |
| CON group | Placebo comparator | Other: CON group |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- football player
- free of injuries
- free of medical conditions contraindicated by hyperbaric oxygen therapy (HBOT)
- written parental consent
Key exclusion criteria (4 listed)
- pre-existing injuries or medical conditions that are contraindicated by hyperbaric oxygen therapy (HBOT)
- participation in severe physical activity within 24 hours before the study
- participants who do not comply with the requirement to abstain from breakfast, caffeine, and alcohol prior to the first blood collection
- an active respiratory illness, such as a cold, at the time of the study
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 |
|---|---|---|
| HBOT groupThe HBOT will be performed in a Barox HBOT chamber (Yaklasim Makina San. Ve Tic. Ltd. Sti). Participants will be taken to the chamber immediately after the football match, where they will sit in individual chairs, and oxygen will be delivered through individual masks. The HBOT group will be exposed to 100% oxygen at 2.2 ATA (atmospheres absolute). Session will last 70 minutes. | Other | HBOT group |
| CON groupAlso: Control, PlaceboThe placebo protocols will be performed in a Barox HBOT chamber (Yaklasim Makina San. Ve Tic. Ltd. Sti). Participants will be taken to the chamber immediately after the football match, where they will sit in individual chairs, and oxygen will be delivered through individual masks. The CON group will be exposed to normobaric ambient pressure (1 ATA). The session will last 70 minutes. | Other | CON group |
Primary outcome
Myoglobin
Time frame: baseline, 3 hours, 5 hours, 24 hours
Measure of myoglobin concentration in blood. Myoglobin will be determined using Siemens IMMULITE 1000 (Siemens Healthcare Diagnostics, UK).
Creatine kinase
Time frame: baseline, 3 hours, 5 hours, 24 hours
Measure of creatine kinase concentration in blood. It will be analyzed using a biochemistry analyzer (A25 Biosystems Chemistry Analyzer).
Lactate dehydrogenase
Time frame: baseline, 3 hours, 5 hours, 24 hours
Measure of lactate dehydrogenase concentration in blood. It will be analyzed using a biochemistry analyzer (A25 Biosystems Chemistry Analyzer).
Alanine aminotransferase
Time frame: baseline, 3 hours, 5 hours, 24 hours
Measure of alanine aminotransferase concentration in blood. It will be analyzed using a biochemistry analyzer (A25 Biosystems Chemistry Analyzer).
Aspartate aminotransferase
Time frame: baseline, 3 hours, 5 hours, 24 hours
Measure of aspartate aminotransferase concentration in blood. It will be analyzed using a biochemistry analyzer (A25 Biosystems Chemistry Analyzer).
6 secondary outcomes
Squat jump
Time frame: baseline, 3 hours, 5 hours, 24 hours
Countermovement jump
Time frame: baseline, 3 hours, 5 hours, 24 hours
Countermovement jump with arm swing
Time frame: baseline, 3 hours, 5 hours, 24 hours
5 meter linear speed
Time frame: baseline, 3 hours, 5 hours, 24 hours
10 meter linear speed
Time frame: baseline, 3 hours, 5 hours, 24 hours
20 meter linear speed
Time frame: baseline, 3 hours, 5 hours, 24 hours
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 1 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBOT group and CON group in people with Performance Enhancing Product Use and Physical Fitness, run by University Medical Centre Ljubljana at 1 site in Serbia.
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 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 1 Nov 2023. 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 Serbia. 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. Some participants in this study may receive a placebo. 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?
Myoglobin (time frame: baseline, 3 hours, 5 hours, 24 hours). 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 1 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.