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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05447416
Enrollment
66
Registered
2022-07-07
Start date
2023-06-01
Completion date
2027-12-31
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Active Athletes

Keywords

triathletes, cyclists, mitochondria, HBOT, HBO, IHT

Brief summary

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

Detailed description

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.

Interventions

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

DEVICEIntermittent Hypoxic Training - IHT

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

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomized controlled trail 2 groups treatment - HBOT and IHT

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1. Vo2max above 3500 ml or Vo2max/kg above 50 ml/kg 2. Age 18-45 3. Subjects are active aerobic athletes, training regularly more than 4 exercise sessions per week. 4. Subject willing and able to read, understand and sign an informed consent

Exclusion criteria

1. Inability to attend scheduled clinic visits and/or comply with the study protocol 2. Active malignancy 3. Active smokers 4. Previous treatment of HBOT for any reason prior to study enrollment. 5. Chest pathology incompatible with pressure changes 6. Major orthopedic injury at the past 3 months 7. Inner ear disease 8. Lung pathology 9. The inability to perform an awake brain MRI 10. Claustrophobia 11. Previous neurologic conditions (e.g., Epilepsy, Brain tumors or s/p neurosurgery etc.) 12. Comorbidities and medications that rule out the subject

Design outcomes

Primary

MeasureTime frameDescription
Cardiopulmonary exercise test (CPET)Baseline, 11 weeksCPET determines the gas exchange dynamics that is expected to change through the intervention

Secondary

MeasureTime frameDescription
Cardiopulmonary exercise test (CPET)8 weeks, 16 weeksCPET determines the gas exchange dynamics that is expected to change through the intervention
Time To ExhaustionBaseline, 11 weeks, 16 weeksThe test will be conducted on the SRM high performance ergometer on 105% of the maximal aerobic power
Wingate 30 seconds anaerobic testBaseline, 11 weeks, 16 weeksThe Wingate Anaerobic Test (WAnT) is conducted on the SRM high performance ergometer.
Muscle biopsy for mitochondrial functionBaseline, 11 weeksParticipants 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
Blood test for evaluation of CBCBaseline, 11 weeks, 16 weekscomplete blood count
Blood test for evaluation of HIF-1αBaseline, 7 weeks, 8 weeks, 11 weeks, 16 weeksHypoxic inducible factor 1α levels
Blood test for evaluation of Telomeres lengthBaseline,11 weeks, 16 weeksUsing staining and FACS technology telomere length will be analyzed
Blood test for evaluation of mitochondrial functionBaseline,11 weeksMitochondrial function of Peripheral Blood Mononuclear Cells (PBMC) and Platelets (PLT)

Countries

Israel

Contacts

CONTACTShai Efrati, Prof
efratishai@outlook.com972-8-9779393
PRINCIPAL_INVESTIGATORShai a Efrati, MD

Asaf-Harofhe MC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026