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

NCT ID: NCT05447416

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-12-31

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.

Conditions

Healthy Active Athletes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Hyperbaric Oxygen Therapy - HBOT

Intervention Type: DEVICE

Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes

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.

Group Type: ACTIVE_COMPARATOR

Intermittent Hypoxic Training - IHT

Intervention Type: DEVICE

Each session lasts 60 minutes of 15.2% oxygen at 1.0 ATA. Subjects will be training according to individualized training protocol.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Shay Efrati

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shai a Efrati, MD

Role: PRINCIPAL_INVESTIGATOR

Asaf-Harofhe MC

Locations

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)

Zrifin, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Shai Efrati, Prof

Role: CONTACT

efratishai@outlook.com

972-8-9779393

Facility Contacts

Shai Efrati, Prof

Role: primary

efratishai@outlook.com

972-8-9779393

Other Identifiers

032-20-ASF

Identifier Type: -

Identifier Source: org_study_id