Clinical trial NCT03524989: The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness
Official title: The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Athletes
Keywords: hbot
hyperbaric oxygen
sport
mitochondria
athletes
aerobic
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-05-15
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized blinded controlled 2 groups with SHAM treatment
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of exercise VO2 MAX at 2 months and 4 months
timeFrame: baseline, at 2 months, 4 months
Secondary outcomes:
measure: Change from baseline of maximal respiratory rate
timeFrame: baseline, at 2 months, at 4 months
measure: Change from baseline of basal respiration rate
timeFrame: baseline, at 2 months, at 4 months
measure: Change from baseline of respiration independent adenosine triphosphate (ATP) production (in muscle biopsy
timeFrame: baseline, at 2 months, at 4 months
measure: Change from baseline in body fat/muscle ratio
timeFrame: baseline, at 2 months, at 4 months
measure: Change in maximal vertical jump (meters)
timeFrame: baseline, at 2 months, at 4 months
measure: Change in maximal running speed (km/hr)
timeFrame: baseline, at 2 months, at 4 months
measure: Change in forced expiratory volume at one second (FEV1)
timeFrame: baseline, at 2 months, at 4 months
measure: Change in forced volume capacity (FVC)
timeFrame: baseline, at 2 months, at 4 months
measure: Change in general cognitive function
timeFrame: baseline, at 2 months, at 4 months
measure: Change from baseline of brain blood perfusion in brain MRI
timeFrame: baseline, at 2 months, at 4 months
Other outcomes:
Locations:
city: Ramla
country: Israel
facility: Assaf-Harofeh Medical Center
Study officials:
References:
citation: Hadanny A, Hachmo Y, Rozali D, Catalogna M, Yaakobi E, Sova M, Gattegno H, Abu Hamed R, Lang E, Polak N, Friedman M, Finci S, Zemel Y, Bechor Y, Gal N, Efrati S. Effects of Hyperbaric Oxygen Therapy on Mitochondrial Respiration and Physical Performance in Middle-Aged Athletes: A Blinded, Randomized Controlled Trial. Sports Med Open. 2022 Feb 8;8(1):22. doi: 10.1186/s40798-021-00403-w.