Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-45
SponsorAssaf-Harofeh Medical Center

About this trial

Comparing the effect of HBOT and IHT on aerobic performance of athletes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Vo2max above 3500 ml or Vo2max/kg above 50 ml/kg

Age 18-45

Subjects are active aerobic athletes, training regularly more than 4 exercise sessions per week.

Subject willing and able to read, understand and sign an informed consent

Disqualifiers

Inability to attend scheduled clinic visits and/or comply with the study protocol

Active malignancy

Active smokers

Previous treatment of HBOT for any reason prior to study enrollment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperbaric Oxygen Therapy - HBOT

    Device

    Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes

  • Intermittent Hypoxic Training - IHT

    Device

    Each session lasts 60 minutes of 15.2% oxygen at 1.0 ATA. Subjects will be training according to individualized training protocol.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Hyperbaric Oxygen Therapy - HBOTActive comparator 1 intervention
Group B: Intermittent Hypoxic Training - IHTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cardiopulmonary exercise test (CPET)

CPET determines the gas exchange dynamics that is expected to change through the intervention

Time frame
Baseline, 11 weeks

Secondary outcomes

1

Cardiopulmonary exercise test (CPET)

CPET determines the gas exchange dynamics that is expected to change through the intervention

Time frame
8 weeks, 16 weeks
2

Time To Exhaustion

The test will be conducted on the SRM high performance ergometer on 105% of the maximal aerobic power

Time frame
Baseline, 11 weeks, 16 weeks
3

Wingate 30 seconds anaerobic test

The Wingate Anaerobic Test (WAnT) is conducted on the SRM high performance ergometer.

Time frame
Baseline, 11 weeks, 16 weeks
4

Muscle biopsy for mitochondrial function

Participants will undergo a muscle biopsy, muscle sample will be analyzed using the Oxygraph (Oroboros Inc, Austria) for oxygen respiratory function, as well as staining for mitochondrial proteins

Time frame
Baseline, 11 weeks

Other outcomes

1

Cognitive Function

Cognitive function will be evaluated using the Neurotrax computerized cognitive assessment and the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Time frame
Baseline, 11 weeks
2

Cognitive Function under exercise

Participants will be asked to pedal on a bike on workload correlated to 85% of the second ventilatory threshold obtained during the CPET and will simultaneously perform a Stroop test using the EncephalApp Stroop Test application on a tablet.

Time frame
Baseline, 11 weeks
3

Whole-brain quantitative perfusion imaging

Whole-brain quantitative perfusion imaging will be performed using Dynamic susceptibility contrast (DSC)-MRI technique

Time frame
Baseline, 11 weeks
4

Brain microstructure MRI evaluation

Fractional anisotropy (FA) and Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol

Time frame
Baseline, 11 weeks

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)Recruiting ZrifinIsraelIsrael

Sponsors and contacts

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