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NCT Number: NCT03524989

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

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.

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Key information

Conditions

Healthy Athletes

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assaf-Harofeh Medical Center

Ramla, 70300, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyperbaric oxygen therapy

Device

40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 2 months.

Sham treatment

Device

40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week for 2 months.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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)

  10. 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

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Acronym: SPORTRCT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 15, 2018
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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