NCT06112210

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

15 days

First QC Date

October 18, 2023

Last Update Submit

October 26, 2023

Conditions

Keywords

hyperbaric chamberfootballrecoveryhyperbaric oxygen therapyperformancefatigue

Outcome Measures

Primary Outcomes (5)

  • Myoglobin

    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

    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

    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

    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

    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 Outcomes (6)

  • Squat jump

    baseline, 3 hours, 5 hours, 24 hours

  • Countermovement jump

    baseline, 3 hours, 5 hours, 24 hours

  • Countermovement jump with arm swing

    baseline, 3 hours, 5 hours, 24 hours

  • 5 meter linear speed

    baseline, 3 hours, 5 hours, 24 hours

  • 10 meter linear speed

    baseline, 3 hours, 5 hours, 24 hours

  • +1 more secondary outcomes

Study Arms (2)

HBOT group

EXPERIMENTAL
Other: HBOT group

CON group

PLACEBO COMPARATOR
Other: CON group

Interventions

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.

HBOT 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.

Also known as: Control, Placebo
CON group

Eligibility Criteria

Age16 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • football player
  • free of injuries
  • free of medical conditions contraindicated by hyperbaric oxygen therapy (HBOT)
  • written parental consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyperbaric center Subotica

Subotica, Serbia

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2023

First Posted

November 1, 2023

Study Start

May 20, 2023

Primary Completion

June 4, 2023

Study Completion

June 6, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations