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

Not Applicable

Recruiting

• Conditions: Healthy Active Athletes

• Registration Number: NCT05447416
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

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.

Study Timeline

• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-03
• Study First Posted: 2022-07-07
• Study Start: 2023-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood test for evaluation of Telomeres length	Baseline,11 weeks, 16 weeks	Using staining and FACS technology telomere length will be analyzed
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
Wingate 30 seconds anaerobic test	Baseline, 11 weeks, 16 weeks	The Wingate Anaerobic Test (WAnT) is conducted on the SRM high performance ergometer.
Blood test for evaluation of CBC	Baseline, 11 weeks, 16 weeks	complete blood count
Blood test for evaluation of mitochondrial function	Baseline,11 weeks	Mitochondrial function of Peripheral Blood Mononuclear Cells (PBMC) and Platelets (PLT)
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
Blood test for evaluation of HIF-1α	Baseline, 7 weeks, 8 weeks, 11 weeks, 16 weeks	Hypoxic inducible factor 1α levels

Trial Locations

Locations (1)

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh); 🇮🇱 Zrifin, Israel