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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

Tracking Information
First Submitted Date  ICMJE April 30, 2018
First Posted Date  ICMJE May 15, 2018
Last Update Posted Date May 18, 2018
Estimated Study Start Date  ICMJE May 15, 2018
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness
Official Title  ICMJE The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Healthy
  • Athletes
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Device: Hyperbaric Oxygen Therapy
  • 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
    Intervention: Device: SHAM treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03524989
Other Study ID Numbers  ICMJE 0244-16-ASF
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Assaf Harofeh MC, Assaf-Harofeh Medical Center
Study Sponsor  ICMJE Assaf-Harofeh Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assaf-Harofeh Medical Center
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP