[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473632":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":71,"studyPopulation":66,"armGroups":72,"interventions":84,"overallOfficials":92,"centralContacts":97,"locations":103,"responsibleParty":112,"collaborators":66,"id":115,"slug":66,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":66,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":66,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":106,"whyStopped":66,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Assaf-Harofeh Medical Center","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Cardiopulmonary exercise test (CPET)","CPET determines the gas exchange dynamics that is expected to change through the intervention","Baseline, 11 weeks",[14,16,20,23,26,29,33,37],{"measure":10,"description":11,"timeFrame":15},"8 weeks, 16 weeks",{"measure":17,"description":18,"timeFrame":19},"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",{"measure":21,"description":22,"timeFrame":19},"Wingate 30 seconds anaerobic test","The Wingate Anaerobic Test (WAnT) is conducted on the SRM high performance ergometer.",{"measure":24,"description":25,"timeFrame":12},"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",{"measure":27,"description":28,"timeFrame":19},"Blood test for evaluation of CBC","complete blood count",{"measure":30,"description":31,"timeFrame":32},"Blood test for evaluation of HIF-1α","Hypoxic inducible factor 1α levels","Baseline, 7 weeks, 8 weeks, 11 weeks, 16 weeks",{"measure":34,"description":35,"timeFrame":36},"Blood test for evaluation of Telomeres length","Using staining and FACS technology telomere length will be analyzed","Baseline,11 weeks, 16 weeks",{"measure":38,"description":39,"timeFrame":40},"Blood test for evaluation of mitochondrial function","Mitochondrial function of Peripheral Blood Mononuclear Cells (PBMC) and Platelets (PLT)","Baseline,11 weeks",[42,45,48,51,54,57],{"measure":43,"description":44,"timeFrame":12},"Cognitive Function","Cognitive function will be evaluated using the Neurotrax computerized cognitive assessment and the Cambridge Neuropsychological Test Automated Battery (CANTAB).",{"measure":46,"description":47,"timeFrame":12},"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.",{"measure":49,"description":50,"timeFrame":12},"Whole-brain quantitative perfusion imaging","Whole-brain quantitative perfusion imaging will be performed using Dynamic susceptibility contrast (DSC)-MRI technique",{"measure":52,"description":53,"timeFrame":12},"Brain microstructure MRI evaluation","Fractional anisotropy (FA) and Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol",{"measure":55,"description":56,"timeFrame":12},"Brain functional connectivity imaging","Resting state functional MRI",{"measure":58,"description":59,"timeFrame":60},"Pulse Rate variability and activity","Participants will be asked to wear a smartwatch (Garmin, USA) in the entire time frame of the study.","baseline to 16 weeks",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":65,"observationalModel":66,"timePerspective":66,"maskingInfo":67},"RANDOMIZED","PARALLEL","Randomized controlled trail 2 groups treatment - HBOT and IHT","TREATMENT",null,{"masking":68,"maskingDescription":66,"whoMasked":69},"SINGLE",[70],"OUTCOMES_ASSESSOR","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.\n\nThis 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.\n\nAfter 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.\n\nThe 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.\n\nBoth 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\n\nPhysical 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.",[73,79],{"label":74,"type":75,"description":76,"interventionNames":77},"Hyperbaric Oxygen Therapy - HBOT","ACTIVE_COMPARATOR","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",[78],"Device: Hyperbaric Oxygen Therapy - HBOT",{"label":80,"type":75,"description":81,"interventionNames":82},"Intermittent Hypoxic Training - IHT","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.",[83],"Device: Intermittent Hypoxic Training - IHT",[85,89],{"type":86,"name":74,"description":87,"armGroupLabels":88,"otherNames":66},"DEVICE","Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes",[74],{"type":86,"name":80,"description":90,"armGroupLabels":91,"otherNames":66},"Each session lasts 60 minutes of 15.2% oxygen at 1.0 ATA. Subjects will be training according to individualized training protocol.",[80],[93],{"name":94,"affiliation":95,"role":96},"Shai a Efrati, MD","Asaf-Harofhe MC","PRINCIPAL_INVESTIGATOR",[98],{"name":99,"role":100,"phone":101,"phoneExt":66,"email":102},"Shai Efrati, Prof","CONTACT","972-8-9779393","efratishai@outlook.com",[104],{"facility":105,"status":106,"city":107,"state":66,"zip":66,"country":108,"countryCode":109,"cosmosGeoPoint":66,"geoPoint":66,"contacts":110},"The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)","RECRUITING","Zrifin","Israel","IL",[111],{"name":99,"role":100,"phone":101,"phoneExt":66,"email":102},{"type":96,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"Shay Efrati","MD","100473632",false,"NCT05447416","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","Inclusion Criteria:\n\n1. Vo2max above 3500 ml or Vo2max\u002Fkg above 50 ml\u002Fkg\n2. Age 18-45\n3. Subjects are active aerobic athletes, training regularly more than 4 exercise sessions per week.\n4. Subject willing and able to read, understand and sign an informed consent\n\nExclusion Criteria:\n\n1. Inability to attend scheduled clinic visits and\u002For comply with the study protocol\n2. Active malignancy\n3. Active smokers\n4. Previous treatment of HBOT for any reason prior to study enrollment.\n5. Chest pathology incompatible with pressure changes\n6. Major orthopedic injury at the past 3 months\n7. Inner ear disease\n8. Lung pathology\n9. The inability to perform an awake brain MRI\n10. Claustrophobia\n11. Previous neurologic conditions (e.g., Epilepsy, Brain tumors or s\u002Fp neurosurgery etc.)\n12. Comorbidities and medications that rule out the subject",true,"MALE","18 Years","45 Years",{"count":126,"type":127},66,"ESTIMATED","INTERVENTIONAL",[130],"NA","Comparing the effect of HBOT and IHT on aerobic performance of athletes.",[133],"Healthy Active Athletes",[135,136,137,138,139,140],"triathletes","cyclists","mitochondria","HBOT","HBO","IHT","2026-04-16",{"date":143,"type":144},"2026-04-21","ACTUAL",{"date":146,"type":144},"2023-06-01",{"date":148,"type":127},"2027-12-31",{"name":5,"class":6},1]