NCT05447416

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jun 2023Dec 2027

First Submitted

Initial submission to the registry

July 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

July 3, 2022

Last Update Submit

April 16, 2026

Conditions

Healthy Active Athletes

Keywords

triathletescyclistsmitochondriaHBOTHBOIHT

Outcome Measures

Primary Outcomes (1)

  • Cardiopulmonary exercise test (CPET)

    CPET determines the gas exchange dynamics that is expected to change through the intervention

    Baseline, 11 weeks

Secondary Outcomes (8)

  • Cardiopulmonary exercise test (CPET)

    8 weeks, 16 weeks

  • Time To Exhaustion

    Baseline, 11 weeks, 16 weeks

  • Wingate 30 seconds anaerobic test

    Baseline, 11 weeks, 16 weeks

  • Muscle biopsy for mitochondrial function

    Baseline, 11 weeks

  • Blood test for evaluation of CBC

    Baseline, 11 weeks, 16 weeks

  • +3 more secondary outcomes

Other Outcomes (6)

  • Cognitive Function

    Baseline, 11 weeks

  • Cognitive Function under exercise

    Baseline, 11 weeks

  • Whole-brain quantitative perfusion imaging

    Baseline, 11 weeks

  • +3 more other outcomes

Study Arms (2)

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

Device: Hyperbaric Oxygen Therapy - HBOT

Intermittent Hypoxic Training - IHT

ACTIVE COMPARATOR

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

Interventions

Hyperbaric Oxygen Therapy - HBOTDEVICE

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

Hyperbaric Oxygen Therapy - HBOT
Intermittent Hypoxic Training - IHTDEVICE

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

Intermittent Hypoxic Training - IHT

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale biologically
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Zrifin, Israel

RECRUITING

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Shai a Efrati, MD

    Asaf-Harofhe MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shai Efrati, Prof

CONTACT

972-8-9779393efratishai@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trail 2 groups treatment - HBOT and IHT
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 3, 2022

First Posted

July 7, 2022

Study Start

June 1, 2023

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)