Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperbaric Oxygen Therapy - HBOT, Intermittent Hypoxic Training - IHT.
- Who it may be relevant to
- Registry conditions: Healthy Active Athletes. Basic parameters: 18 years — 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance - Prospective Randomized Study
Overview
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
- Device Hyperbaric Oxygen Therapy - HBOT
Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes - Device Intermittent 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.
Primary outcome measures
- Cardiopulmonary exercise test (CPET) [Time frame: Baseline, 11 weeks]
Secondary outcome measures (8)
- Cardiopulmonary exercise test (CPET) [Time frame: 8 weeks, 16 weeks]
- Time To Exhaustion [Time frame: Baseline, 11 weeks, 16 weeks]
- Wingate 30 seconds anaerobic test [Time frame: Baseline, 11 weeks, 16 weeks]
- Muscle biopsy for mitochondrial function [Time frame: Baseline, 11 weeks]
- Blood test for evaluation of CBC [Time frame: Baseline, 11 weeks, 16 weeks]
- Blood test for evaluation of HIF-1α [Time frame: Baseline, 7 weeks, 8 weeks, 11 weeks, 16 weeks]
- Blood test for evaluation of Telomeres length [Time frame: Baseline,11 weeks, 16 weeks]
- Blood test for evaluation of mitochondrial function [Time frame: Baseline,11 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh — Zrifin
Identifiers
NCT: NCT05447416 · 0032-20-ASF