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

Sponsor

Assaf-Harofeh Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05447416

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Active Athletes	Device: Hyperbaric Oxygen Therapy - HBOT Device: Intermittent Hypoxic Training - IHT	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trail 2 groups treatment - HBOT and IHTRandomized controlled trail 2 groups treatment - HBOT and IHT

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Cardiopulmonary exercise test (CPET) [Baseline, 11 weeks]
CPET determines the gas exchange dynamics that is expected to change through the intervention

Secondary Outcome Measures

Cardiopulmonary exercise test (CPET) [8 weeks, 16 weeks]
CPET determines the gas exchange dynamics that is expected to change through the intervention
Time To Exhaustion [Baseline, 11 weeks, 16 weeks]
The test will be conducted on the SRM high performance ergometer on 105% of the maximal aerobic power
Wingate 30 seconds anaerobic test [Baseline, 11 weeks, 16 weeks]
The Wingate Anaerobic Test (WAnT) is conducted on the SRM high performance ergometer.
Agility Test [Baseline, 11 weeks, 16 weeks]
Participants will be tested using the MicroGate Witty Sem system of light sensors
Muscle biopsy for mitochondrial function [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
Blood test for evaluation of CBC [Baseline, 11 weeks, 16 weeks]
complete blood count
Blood test for evaluation of HIF-1α [Baseline, 7 weeks, 8 weeks, 11 weeks, 16 weeks]
Hypoxic inducible factor 1α levels
Blood test for evaluation of Telomeres length [Baseline,11 weeks, 16 weeks]
Using staining and FACS technology telomere length will be analyzed
Blood test for evaluation of mitochondrial function [Baseline,11 weeks]
Mitochondrial function of Peripheral Blood Mononuclear Cells (PBMC) and Platelets (PLT)

Other Outcome Measures

Cognitive Function [Baseline, 11 weeks]
Cognitive function will be evaluated using the Neurotrax computerized cognitive assessment and the CNS Vital Signs.
Cognitive Function under exercise [Baseline, 11 weeks]
Participants will be asked to run on a treadmill on workload correlated to the second ventilatory threshold obtained during the CPET and will be tested cognitively using the Witty-Sem (Microgate, Italy).
Whole-brain quantitative perfusion imaging [Baseline, 11 weeks]
Whole-brain quantitative perfusion imaging will be performed using Dynamic susceptibility contrast (DSC)-MRI technique
Brain microstructure MRI evaluation [Baseline, 11 weeks]
Fractional anisotropy (FA) and Mean diffusivity (MD) will be evaluated using diffusion tensor imaging (DTI) MRI protocol
Brain functional connectivity imaging [Baseline, 11 weeks]
Resting state functional MRI
EEG analysis [Baseline, 11 weeks]
EEG will be performed using a dry-electrodes platform of 64-484 electrodes.
Pulse Rate variability and activity [baseline to 16 weeks]
Participants will be asked to wear a smartwatch (Garmin, USA) in the entire time frame of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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