The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness (SPORTRCT)

December 5, 2022 updated by: Assaf Harofeh MC, Assaf-Harofeh Medical Center
Previous evidence showed hyperbaric oxygen can enhance aerobic and anaerobic performance during the exposure. The effect of continuous exposure of hyperbaric oxygen on performance was never evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In recent years, several options for physical performance enhancement by increasing blood oxygen content were explored. One option is increasing the number of red blood cells by blood transfusions. Another option is using the erythropoietin hormone. These methods showed an effective increase of maximal oxygen consumption rate (VO2MAX) by 10%. However, due to their inherent risks, the international sports associations banned their uses. A third option of training in high altitude environments, but this option was never proved to be effective.

Another strategy would be increasing the blood oxygen content by increasing the plasma dissolved oxygen concentration. This would only be possible using hyperbaric oxygen therapy -which includes inhaling 100% oxygen in a pressure higher than the normal atmospheric pressure.

Previous evidence showed hyperbaric oxygen can enhance aerobic and anaerobic performance during the exposure. These studies evaluated the effect during a single hyperbaric oxygen exposure. The effect of continuous exposure of hyperbaric oxygen on performance was never evaluated.

The study is designed as a randomized controlled study aiming to evaluate the therapeutic effects of hyperbaric oxygen therapy (HBOT) on the aerobic and anaerobic performance.

After signing an informed consent form, patients will be randomized into 2 groups: treatment and control group. Patients will be invited for baseline evaluations. All patients would be evaluated 2 times - at baseline and after 2 months of follow up, The evaluation will include physical examination, VO2MAX, muscle biopsy for mitochondrial function, aerobic function measurements, cognitive assessment, brain MRI, brain EEG.

Protocols:

Treatment: Patients will receive 40 daily sessions, 5 days/week, 60 minutes each with 5 minutes air break every 30 minutes, 100% oxygen at 2 atmospheres (ATA).

Control: Patients will receive 40 daily sessions, 5 days/week, 60 minutes each with 5 minutes air break every 30 minutes, 21% oxygen (air) at 1.01 ATA.

Upon completion of the study, control group would be offered to crossover and complete additional 40 sessions of 100% oxygen at 2 ATA. A third evaluation would be performed in case patients will complete the protocol.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramla, Israel, 70300
        • Assaf-Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-25 or 40-50 age
  • Professional performance of aerobic sports for ages 18-25 (at least 5 times a week)
  • Moderate and above performance of aerobic sports for ages 40-50 (at least 4 times a week)
  • no chronic illness
  • no significant musculoskeletal injury in the past 3 months

Exclusion Criteria:

  • Debilitating significant musculoskeletal injury
  • Previous hyperbaric oxygen exposure
  • Lung pathology
  • Middle or Inner ear pathology
  • Claustrophobia
  • Chronic illness
  • Smoking
  • Chronic medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment
Hyperbaric Oxygen Therapy: 2 months of treatment consisting of 40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week
Device: Hyperbaric Oxygen Therapy
40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 2 months.
Sham Comparator: Control/Crossover
SHAM therapy: 2 months of treatment consisting of 40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week
Device: SHAM treatment
40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week for 2 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of exercise VO2 MAX at 2 months and 4 months
Time Frame: baseline, at 2 months, 4 months
Using a standard exercise test which includes gas analysis, the change in VO2 maxs will be assessed 2 months and 4 months compared to baseline
baseline, at 2 months, 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of maximal respiratory rate
Time Frame: baseline, at 2 months, at 4 months
Using a trucut needle, the gluteus maximus will be sampled in a sterile technique for 1-2mg of muscle tissue. Oroboros O2k high resolution respirometry analyzer will be used (Oxygraph-2k Oroboros Instruments, Innsbruck, Austria). Maximal respiration rate (nmol/ml) will be calculated.
baseline, at 2 months, at 4 months
Change from baseline of basal respiration rate
Time Frame: baseline, at 2 months, at 4 months
Using a trucut needle, the gluteus maximus will be sampled in a sterile technique for 1-2mg of muscle tissue. Oroboros O2k high resolution respirometry analyzer will be used (Oxygraph-2k Oroboros Instruments, Innsbruck, Austria). Basal respiration rate (nmol/ml) will be measured where mitochondrial reserve capacity and ATP-linked respiration will be calculated.
baseline, at 2 months, at 4 months
Change from baseline of respiration independent adenosine triphosphate (ATP) production (in muscle biopsy
Time Frame: baseline, at 2 months, at 4 months
Using a trucut needle, the gluteus maximus will be sampled in a sterile technique for 1-2mg of muscle tissue. Oroboros O2k high resolution respirometry analyzer will be used (Oxygraph-2k Oroboros Instruments, Innsbruck, Austria). Inpendent adenosine triphosphate (ATP) production (proton leak) (nmol/ml) will be calculated.
baseline, at 2 months, at 4 months
Change from baseline in body fat/muscle ratio
Time Frame: baseline, at 2 months, at 4 months
Using an electric current weight, the fat % and muscle % content will be measured.
baseline, at 2 months, at 4 months
Change in maximal vertical jump (meters)
Time Frame: baseline, at 2 months, at 4 months
Maximal running speed, maximal vertical jump height will be measured according the standards.
baseline, at 2 months, at 4 months
Change in maximal running speed (km/hr)
Time Frame: baseline, at 2 months, at 4 months
Maximal running speed will be measured according the standards.
baseline, at 2 months, at 4 months
Change in forced expiratory volume at one second (FEV1)
Time Frame: baseline, at 2 months, at 4 months
Using a standard spirometry, forced expiratory volume at one second (FEV1) (liters/second) will be measured
baseline, at 2 months, at 4 months
Change in forced volume capacity (FVC)
Time Frame: baseline, at 2 months, at 4 months
Using a standard spirometry, forced volume capacity (FVC) (liters/second) will be measured
baseline, at 2 months, at 4 months
Change in general cognitive function
Time Frame: baseline, at 2 months, at 4 months
Patients' cognitive functions will be assessed by Neurotrax computerized cognitive tests to generate the general cognitive index (0-100)
baseline, at 2 months, at 4 months
Change from baseline of brain blood perfusion in brain MRI
Time Frame: baseline, at 2 months, at 4 months
imaging will be performed for evaluation of brain changes and angiogenesis process using MRI perfusion and microstructure
baseline, at 2 months, at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2018

Primary Completion (Actual)

September 15, 2021

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (Actual)

May 15, 2018

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0244-16-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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