The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness
Condition: Healthy; Athletes
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Hyperbaric Oxygen Therapy; SHAM treatment
Intervention type(s): Device; Device
Intervention description(s): 40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 2 months.; 40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week for 2 months.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized blinded controlled 2 groups with SHAM treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hbot; hyperbaric oxygen; sport; mitochondria; athletes; aerobic