The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness
NCT ID: NCT03524989
Last Updated: 2022-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2018-05-15
2021-09-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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
Hyperbaric Oxygen Therapy
40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 2 months.
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
SHAM treatment
40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week for 2 months.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous hyperbaric oxygen exposure
* Lung pathology
* Middle or Inner ear pathology
* Claustrophobia
* Chronic illness
* Smoking
* Chronic medications
18 Years
50 Years
ALL
Yes
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Assaf Harofeh MC
MD
Locations
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Assaf-Harofeh Medical Center
Ramla, , Israel
Countries
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References
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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.
Other Identifiers
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0244-16-ASF
Identifier Type: -
Identifier Source: org_study_id
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