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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy, Athletes

Intervention / Treatment
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* Device: Hyperbaric Oxygen Therapy
* Device: SHAM treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized blinded controlled 2 groups with SHAM treatment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>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<br>* 40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 2 months.<br>|
| Sham Comparator: Control/Crossover<br>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<br>* 40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week for 2 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of exercise VO2 MAX at 2 months and 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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 | 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 | imaging will be performed for evaluation of brain changes and angiogenesis process using MRI perfusion and microstructure | baseline, at 2 months, at 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sport, hbot, hyperbaric oxygen, mitochondria, athletes, aerobic