Effectiveness of Hyperbaric Oxygen Therapy in Adults

NCT ID: NCT06284603

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-12-20

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. 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. Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?

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?

Participants are exposed to hyperoxia under hyperbaric conditions or form a control group with no treatment.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group 1: HBOT 3/week

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

Group Type: ACTIVE_COMPARATOR

Hyperbaric Oxygen Therapy - HBOT

Intervention Type: 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 2: HBOT 6/week

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

Group Type: ACTIVE_COMPARATOR

Hyperbaric Oxygen Therapy - HBOT

Intervention Type: 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

Control Group

No changes to a daily routine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hyperbaric Oxygen Therapy - HBOT

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Inability to attend scheduled visits and/or follow study protocol;
• Use of HBOT prior to study inclusion;
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Poznan University of Physical Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Pospieszna, PhD.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Poznan University of Physical Education

Poznan, Wielkopolska, Poland

Countries

Poland

Other Identifiers

AWF_LA_HBOT

Identifier Type: -

Identifier Source: org_study_id