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

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ClinicalTrials.gov Identifier: NCT03524989
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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
Estimated Study Start Date : May 15, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524989


Locations
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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

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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    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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