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

S

Shamir Medical Center (Assaf-Harofeh)

Status

Completed

Conditions

Healthy
Athletes

Treatments

Device: Hyperbaric Oxygen Therapy
Device: SHAM treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03524989
0244-16-ASF

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

59 participants in 2 patient groups

Treatment
Active Comparator group
Description:
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
Treatment:
Device: Hyperbaric Oxygen Therapy
Control/Crossover
Sham Comparator group
Description:
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
Treatment:
Device: SHAM treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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