The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Zrifin, Israel
Location status: Recruiting
NCT Number: NCT05447416
Comparing the effect of HBOT and IHT on aerobic performance of athletes.
Interested in participating?
Request Info18 year–45 year
Male
Interventional
Not applicable
Zrifin, Israel
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Each session lasts 60 minutes of 15.2% oxygen at 1.0 ATA. Subjects will be training according to individualized training protocol.
Time frame: Baseline, 11 weeks
CPET determines the gas exchange dynamics that is expected to change through the intervention
Time frame: 8 weeks, 16 weeks
CPET determines the gas exchange dynamics that is expected to change through the intervention
Time frame: Baseline, 11 weeks, 16 weeks
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
The Wingate Anaerobic Test (WAnT) is conducted on the SRM high performance ergometer.
Time frame: Baseline, 11 weeks
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, 16 weeks
complete blood count
Time frame: Baseline, 7 weeks, 8 weeks, 11 weeks, 16 weeks
Hypoxic inducible factor 1α levels
Time frame: Baseline,11 weeks, 16 weeks
Using staining and FACS technology telomere length will be analyzed
Time frame: Baseline,11 weeks
Mitochondrial function of Peripheral Blood Mononuclear Cells (PBMC) and Platelets (PLT)
Time frame: Baseline, 11 weeks
Cognitive function will be evaluated using the Neurotrax computerized cognitive assessment and the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Time frame: Baseline, 11 weeks
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
Whole-brain quantitative perfusion imaging will be performed using Dynamic susceptibility contrast (DSC)-MRI technique
Time frame: Baseline, 11 weeks
Fractional anisotropy (FA) and Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol
Time frame: Baseline, 11 weeks
Resting state functional MRI
Time frame: baseline to 16 weeks
Participants will be asked to wear a smartwatch (Garmin, USA) in the entire time frame of the study.
Contact information is provided by the study sponsor or research team.
Assaf-Harofeh Medical Center
Other Gov
Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance - Prospective Randomized Study
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