HealthySPORTRCTNCT03524989
The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness
A study testing Hyperbaric Oxygen Therapy in people with Healthy and Athletes, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteIsrael
- Study dates
- 15 May 2018to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Debilitating significant musculoskeletal injury
- Previous hyperbaric oxygen exposure
- Lung pathology
- Middle or Inner ear pathology
- Claustrophobia
- Chronic illness
- Smoking
- Chronic medications
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Hyperbaric Oxygen Therapy, SHAM treatment
- Keywords
- hbot, hyperbaric oxygen, sport, mitochondria, athletes, aerobic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyDevice
40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 2 months.
SHAM treatmentDevice
40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | 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 Receives: Device: Hyperbaric Oxygen Therapy |
| Control/Crossover | Sham comparator | 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 Receives: Device: SHAM treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, at 2 months, 4 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: baseline, at 2 months, at 4 months
Change in maximal running speed (km/hr)
Maximal running speed will be measured according the standards.
Measured: 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
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
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)
Measured: 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
Measured: baseline, at 2 months, at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start15 May 2018
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized blinded controlled 2 groups with SHAM treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shay Efrati, Assaf-Harofeh Medical Center
- Investigators
- Shai a Efrati, MD, Principal investigator, Asaf-Harofhe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524989
- Sponsor's protocol ID
- 0244-16-ASF
- Acronym
- SPORTRCT
- Status last verified
- May 2026
- First submitted
- 30 Apr 2018
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35133516
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness
- ClinicalTrials.gov ID
- NCT03524989
- Acronym / sponsor ID
- SPORTRCT / 0244-16-ASF
- Keywords
- hbot, hyperbaric oxygen, sport, mitochondria, athletes, aerobic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 15 May 2018 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized blinded controlled 2 groups with SHAM treatment
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: Hyperbaric Oxygen TherapyHyperbaric 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 |
| Control/Crossover | Sham comparator | Device: SHAM treatmentSHAM 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Debilitating significant musculoskeletal injury
- Previous hyperbaric oxygen exposure
- Lung pathology
- Middle or Inner ear pathology
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen Therapy40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 2 months. | Device | Treatment |
| SHAM treatment40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week for 2 months. | Device | Control/Crossover |
Primary outcome
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
10 secondary outcomes
Change from baseline of maximal respiratory rate
Time frame: baseline, at 2 months, at 4 months
Change from baseline of basal respiration rate
Time frame: baseline, at 2 months, at 4 months
Change from baseline of respiration independent adenosine triphosphate (ATP) production (in muscle biopsy
Time frame: baseline, at 2 months, at 4 months
Change from baseline in body fat/muscle ratio
Time frame: baseline, at 2 months, at 4 months
Change in maximal vertical jump (meters)
Time frame: baseline, at 2 months, at 4 months
Change in maximal running speed (km/hr)
Time frame: baseline, at 2 months, at 4 months
Change in forced expiratory volume at one second (FEV1)
Time frame: baseline, at 2 months, at 4 months
Change in forced volume capacity (FVC)
Time frame: baseline, at 2 months, at 4 months
Change in general cognitive function
Time frame: baseline, at 2 months, at 4 months
Change from baseline of brain blood perfusion in brain MRI
Time frame: baseline, at 2 months, at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 35133516Hadanny 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shai a Efrati, MD principal investigator
Asaf-Harofhe MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy in people with Healthy and Athletes, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of exercise VO2 MAX at 2 months and 4 months (time frame: baseline, at 2 months, 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.