Effectiveness of Hyperbaric Oxygen Therapy in Adults

NCT06284603 | Completed

• 1 other identifier: AWF_LA_HBOT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this controlled, experimental study is to learn about the effects of 10 sessions of hyperbaric oxygen therapy on physical performance, vascular circulation, biochemical parameters, and composition of the intestinal microbiota in young healthy men depending on the frequency of single treatments. The main questions it aims to answer are:

1. 1.Do 10 treatments of hyperbaric oxygen therapy induce significant changes in physical performance levels, vascular circulation, and concentrations of biochemical parameters in young, healthy men?
2. 2.Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?
3. 3.Does a series of hyperbaric oxygen therapy treatments induce significant changes in the composition of the intestinal microbiota, metabolome, and functional status of the intestines?

Conditions

Healthy

Keywords

physical performance; vascular circulation; gut microbiota

Outcome Measures

Primary Outcomes (3)

• Volume of oxygen and carbon dioxide

  A cardiopulmonary exercise test (CPET) is conducted while an incremental running test on the treadmill using a portable breath-by-breath ergospirometer; VO2 and VCO2 are measured constantly.

  baseline and the next morning after the last HBOT intervention; up to 24 days.

• Heart rate

  Cardiopulmonary exercise test (CPET) is conducted while an incremental running test on the treadmill using a heart rate monitor.

  baseline and the next morning after the last HBOT intervention; up to 24 days.

• Vascular circulation measures

  Nicotinamide adenine dinucleotide (NADH) content changes in the skin area are measured during transient ischemia and reperfusion with the use of the Flow Mediated Skin Fluorescence (FMSF) using The AngioExpert device (AngioExpert, Poland)

  baseline (before and immediately after CPET), before and after 5th treatment, and the next morning after the last HBOT intervention (before and immediately after CPET); up to 24 days.

Secondary Outcomes (11)

• Body composition (body mass, fat mass, lean body mass, muscle mass)

  baseline and the next morning after the last HBOT intervention; up to 24 days.

• Inflammatory cytokine profile

  baseline and the next morning after the last HBOT intervention; up to 24 days.

• Oxidative stress indicators

  baseline and the next morning after the last HBOT intervention; up to 24 days.

• F2-Isoprostanes (F2-IsoP)

  baseline and the next morning after the last HBOT intervention; up to 24 days.

• Brain-derived neurotrophic factor concentration (BDNF)

  baseline and the next morning after the last HBOT intervention; up to 24 days.

Study Arms (3)

Study Group 1: HBOT 3/week

ACTIVE COMPARATOR

The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 3 sessions per week.

Device: Hyperbaric Oxygen Therapy - HBOT

Study Group 2: HBOT 6/week

ACTIVE COMPARATOR

The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 6 sessions per week.

Device: Hyperbaric Oxygen Therapy - HBOT

Control Group

NO INTERVENTION

No changes to a daily routine.

Interventions

Hyperbaric Oxygen Therapy - HBOT DEVICE

Each session includes exposure of 60 minutes to 100% oxygen at 2.5 atmosphere absolute (ATA), with 5-minute air breaks every 20 minutes

Study Group 1: HBOT 3/week; Study Group 2: HBOT 6/week

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-35;
• Healthy, physically active men;
• Subject who is knowingly willing to participate in the study;
• Subject able to read, understand and sign an informed consent to participate.

You may not qualify if:

• Inability to attend scheduled visits and/or follow study protocol;
• Severe or unstable physical impairment or severe cognitive deficits at study entry;
• Pressure-sensitive chest diseases (including moderate or severe asthma) or pressure-sensitive ear or sinus diseases;
• Active smoking;
• Having suffered an injury within 3 months up to the date of the study;
• Taking pre- and/or probiotics in the last 3 months before the study;
• Inpatient hospital or emergency room stay in the last 4 weeks prior to study entry;
• Travel to tropical countries during the last 4 weeks prior to the study;
• Taking antibiotics, steroids and steroid-anabolic agents during the last 4 weeks before the study

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Poznan University of Physical Education

Poznan, Wielkopolska, 61-871, Poland

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Barbara Pospieszna, PhD.

  Department of Athletics, Strength and Conditioning, Poznan Univ of Physical Ed, Poznan, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two study groups (dependent on frequency of HBOT treatments) and control group

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 29, 2024
• Study Start: March 1, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: February 29, 2024

Record last verified: 2023-09

Locations

PL (1)