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

• ClinicalTrials.gov Identifier: NCT03524989
• Recruitment Status: Unknown
• First Posted: May 15, 2018
• Last Update Posted: April 8, 2020
• Sponsor: Assaf-Harofeh Medical Center
• Information provided by (Responsible Party): Assaf Harofeh MC, Assaf-Harofeh Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy; Athletes	Device: Hyperbaric Oxygen Therapy; Device: SHAM treatment	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• 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
• Official Title: The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness
• Actual Study Start Date: May 15, 2018
• Estimated Primary Completion Date: August 1, 2020
• Estimated Study Completion Date: October 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Treatment; 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; 40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 2 months.
Sham Comparator: Control/Crossover; 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; 40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week for 2 months.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Change from baseline of maximal respiratory rate [ Time Frame: baseline, at 2 months, at 4 months ]
   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.
2. Change from baseline of basal respiration rate [ Time Frame: baseline, at 2 months, at 4 months ]
   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.
3. Change from baseline of respiration independent adenosine triphosphate (ATP) production (in muscle biopsy [ Time Frame: baseline, at 2 months, at 4 months ]
   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.
4. Change from baseline in body fat/muscle ratio [ Time Frame: baseline, at 2 months, at 4 months ]
   Using an electric current weight, the fat % and muscle % content will be measured.
5. Change in maximal vertical jump (meters) [ Time Frame: baseline, at 2 months, at 4 months ]
   Maximal running speed, maximal vertical jump height will be measured according the standards.
6. Change in maximal running speed (km/hr) [ Time Frame: baseline, at 2 months, at 4 months ]
   Maximal running speed will be measured according the standards.
7. Change in forced expiratory volume at one second (FEV1) [ Time Frame: baseline, at 2 months, at 4 months ]
   Using a standard spirometry, forced expiratory volume at one second (FEV1) (liters/second) will be measured
8. Change in forced volume capacity (FVC) [ Time Frame: baseline, at 2 months, at 4 months ]
   Using a standard spirometry, forced volume capacity (FVC) (liters/second) will be measured
9. Change in general cognitive function [ Time Frame: baseline, at 2 months, at 4 months ]
   Patients' cognitive functions will be assessed by Neurotrax computerized cognitive tests to generate the general cognitive index (0-100)
10. Change from baseline of brain blood perfusion in brain MRI [ Time Frame: baseline, at 2 months, at 4 months ]
    imaging will be performed for evaluation of brain changes and angiogenesis process using MRI perfusion and microstructure

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Israel

Assaf-Harofeh Medical Center; Recruiting

Ramla, Israel, 70300

Contact: Shai Efrati, MD 97289779395 hbo@asaf.health.gov.il

Contact: Amir Hadanny, MD 97289779395 hbo@asaf.health.gov.il

Principal Investigator: Amir Hadanny, MD

Sponsors and Collaborators

Assaf-Harofeh Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Assaf Harofeh MC, MD, Assaf-Harofeh Medical Center
• ClinicalTrials.gov Identifier: NCT03524989
• Other Study ID Numbers: 0244-16-ASF
• First Posted: May 15, 2018
• Last Update Posted: April 8, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assaf Harofeh MC, Assaf-Harofeh Medical Center:

hbot; hyperbaric oxygen; sport; mitochondria; athletes; aerobic