- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06112210
Effect of Hyperbaric Oxygen Therapy
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:
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Subotica, Serbia
- Hyperbaric center Subotica
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- football player
- free of injuries
- free of medical conditions contraindicated by hyperbaric oxygen therapy (HBOT)
- written parental consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HBOT group
|
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.
|
Placebo Comparator: CON group
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
baseline, 3 hours, 5 hours, 24 hours
|
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).
|
baseline, 3 hours, 5 hours, 24 hours
|
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).
|
baseline, 3 hours, 5 hours, 24 hours
|
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).
|
baseline, 3 hours, 5 hours, 24 hours
|
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).
|
baseline, 3 hours, 5 hours, 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Squat jump
Time Frame: baseline, 3 hours, 5 hours, 24 hours
|
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.
|
baseline, 3 hours, 5 hours, 24 hours
|
Countermovement jump
Time Frame: baseline, 3 hours, 5 hours, 24 hours
|
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.
|
baseline, 3 hours, 5 hours, 24 hours
|
Countermovement jump with arm swing
Time Frame: baseline, 3 hours, 5 hours, 24 hours
|
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.
|
baseline, 3 hours, 5 hours, 24 hours
|
5 meter linear speed
Time Frame: baseline, 3 hours, 5 hours, 24 hours
|
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.
|
baseline, 3 hours, 5 hours, 24 hours
|
10 meter linear speed
Time Frame: baseline, 3 hours, 5 hours, 24 hours
|
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.
|
baseline, 3 hours, 5 hours, 24 hours
|
20 meter linear speed
Time Frame: baseline, 3 hours, 5 hours, 24 hours
|
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.
|
baseline, 3 hours, 5 hours, 24 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HBstudy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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