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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Active Athletes
• Intervention / Treatment: Device: Hyperbaric Oxygen Therapy - HBOT; Device: Intermittent Hypoxic Training - IHT

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shai Efrati, Prof; Phone Number: 972-8-9779393; Email: efratishai@outlook.com

Study Locations

• Israel
  • Zrifin, Israel
    • Recruiting
    • The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
    • Contact: Shai Efrati, Prof; Phone Number: 972-8-9779393; Email: efratishai@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyperbaric Oxygen Therapy - HBOT; 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; Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
Active Comparator: 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.	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole-brain quantitative perfusion imaging	Whole-brain quantitative perfusion imaging will be performed using Dynamic susceptibility contrast (DSC)-MRI technique	Baseline, 11 weeks
Brain microstructure MRI evaluation	Fractional anisotropy (FA) and Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol	Baseline, 11 weeks
Brain functional connectivity imaging	Resting state functional MRI	Baseline, 11 weeks
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
Cognitive Function	Cognitive function will be evaluated using the Neurotrax computerized cognitive assessment and the Cambridge Neuropsychological Test Automated Battery (CANTAB).	Baseline, 11 weeks
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.	Baseline, 11 weeks

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: July 3, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: mitochondria; IHT; HBOT; cyclists; HBO; triathletes
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 032-20-ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No