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

Study Overview
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Brief Summary
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Comparing the effect of HBOT and IHT on aerobic performance of athletes.

Detailed Description
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Enhanced physical performance is the goal of all professional and non-professional athletes. There are many intervention methods aim to enhance physical performance from 2 intervention related to change in the environment partial oxygen pressure have been demonstrated to have beneficial effect: IHT and HBOT. This study offers one of the two interventions to athletes with a pre and post intervention objective evaluation of the physiological performance - Maximal exercise test for evaluating VO2MAX and ventilatory thresholds, time to exhaustion, 30 seconds Wingate test, agility test, muscle biopsy, blood tests, brain MRI, cognitive tests and exercise cognitive test. After signing an informed consent form, eligible subjects will be randomized to one of the study groups at a ratio of 1:1. The IHT group will receive three hypoxic guided training sessions per week, according an individualized training protocol, 24 sessions in total. The HBOT group will receive 40 daily hyperbaric sessions, five days per week. Each session will include 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes. Three times per week, as the IHT group, the HBOT group will have a guided training session, according an individualized training protocol. Both groups, IHT and HBOT, will have the same relative intensity guided training protocols for 8 weeks, to stimulate the same exercise load. The IHT group will train for 60 minutes, 3 times a week in a normobaric hypoxia environment, at O2 concentration of 15.2% that stimulates a 2500-2600m height. The HBOT group will train for 60 minutes after the HBOT sessions, 3 times per week, in a normobaric normoxic environment Physical performance evaluations will be conducted on 3 different times post interventions - a day last intervention, 3 weeks after and 2 months after - in order to analyze the long term effect of each intervention.

Official Title
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Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance - Prospective Randomized Study

Conditions
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Healthy Active Athletes

Intervention / Treatment
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* Device: Hyperbaric Oxygen Therapy - HBOT
* Device: Intermittent Hypoxic Training - IHT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. Chest pathology incompatible with pressure changes Major orthopedic injury at the past 3 months Inner ear disease Lung pathology The inability to perform an awake brain MRI Claustrophobia Previous neurologic conditions (e.g., Epilepsy, Brain tumors or s/p neurosurgery etc.) Comorbidities and medications that rule out the subject

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trail 2 groups treatment - HBOT and IHT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyperbaric Oxygen Therapy - HBOT<br>The protocol comprises of 40 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a two months' period. The HBOT group will train for 60 minutes after the HBOT sessions, 3 times per week, in a normobaric normoxic environment according to individualized training protocol | Device: Hyperbaric Oxygen Therapy - HBOT<br>* Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes<br>|
| Active Comparator: Intermittent Hypoxic Training - IHT<br>The protocol comprises of 24 consecutive Intermittent Hypoxic Training (IHT) sessions, 3 sessions per week within a two months' period. Subjects will train according to individualized training protocol. | Device: Intermittent Hypoxic Training - IHT<br>* Each session lasts 60 minutes of 15.2% oxygen at 1.0 ATA. Subjects will be training according to individualized training protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary exercise test (CPET) | CPET determines the gas exchange dynamics that is expected to change through the intervention | Baseline, 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary exercise test (CPET) | CPET determines the gas exchange dynamics that is expected to change through the intervention | 8 weeks, 16 weeks | 
| Time To Exhaustion | The test will be conducted on the SRM high performance ergometer on 105% of the maximal aerobic power | Baseline, 11 weeks, 16 weeks | 
| Wingate 30 seconds anaerobic test | The Wingate Anaerobic Test (WAnT) is conducted on the SRM high performance ergometer. | Baseline, 11 weeks, 16 weeks | 
| 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 | Baseline, 11 weeks | 
| Blood test for evaluation of CBC | complete blood count | Baseline, 11 weeks, 16 weeks | 
| Blood test for evaluation of HIF-1α | Hypoxic inducible factor 1α levels | Baseline, 7 weeks, 8 weeks, 11 weeks, 16 weeks | 
| Blood test for evaluation of Telomeres length | Using staining and FACS technology telomere length will be analyzed | Baseline,11 weeks, 16 weeks | 
| Blood test for evaluation of mitochondrial function | Mitochondrial function of Peripheral Blood Mononuclear Cells (PBMC) and Platelets (PLT) | Baseline,11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBO, triathletes, cyclists, mitochondria, HBOT, IHT