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

Healthy Clinical Trial

— SPORTRCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524989
• Other study ID #: 0244-16-ASF
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: September 15, 2021

Study information

• Verified date: December 2022
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Athletes
• Healthy

Intervention

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

Locations

Country	Name	City	State
Israel	Assaf-Harofeh Medical Center	Ramla

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in maximal running speed (km/hr)	Maximal running speed will be measured according the standards.	baseline, at 2 months, at 4 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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