CClinicalTrials.gg
RecruitingNCT07558928forceUpdated Apr 30, 2026

Effect of Hyperoxygenated Environment on Maximal Muscle Strength

An interventional study of Hyperbaric Oxygen Therapy - HBOT and Sham in Healthy Lifestyle, sponsored by Assaf-Harofeh Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

comparing the effect of hyperoxygenated environment on maximal muscle strength in the Mid-thigh Pull Task

Read the detailed description

All three major energy systems - phosphagen, glycolytic, and oxidative - contribute to any given physical effort. However, it has been widely deemed that the contribution of the oxidative energy system (aerobic) to motor tasks at the very high end of the intensity spectrum, such as maximal muscle strength efforts, is close to negligible. Hyperoxygenated environment includes the inhalation of 100% oxygen at pressures exceeding one atmosphere absolute (ATA) in order to enhance the amount of oxygen dissolved in the body tissues. During hyperbaric chamber treatment, the arterial O2 tension typically exceeds 1500 mmHg, and levels of 200-400 mmHg occur in different body tissues.

The isometric mid-thigh pull test (IMTP) is an increasingly popular means to evaluate muscle strength in a multi-joint, large muscle-mass, mostly lower-body motor task.

Our study aims to determine whether a high availability of muscle tissue oxygen, by means of hyperbaric oxygenation, can influence the putative small contribution of the oxidative energy system significantly enough to affect peak-force production in a maximal IMTP.

02

Conditions studied

  • Healthy Lifestyle

Keywords

  • power lifting
  • gym
  • force
  • imtp
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy
  2. Ages 18-45
  3. Participants are physically active and have a recent resistance-training experience of at least six months, ≥ 3 times a week
  4. Participant willing and able to read, understand and sign an informed consent

Exclusion criteria

Exclusion Criteria:

  1. Inability to attend scheduled clinic visits or comply with the study protocol
  2. Active malignancy
  3. Active smokers
  4. Previous treatment of hyperbaric chamber 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. Claustrophobia
  10. Previous neurologic conditions (e.g., epilepsy, brain tumors or s/p neurosurgery etc.)
  11. Comorbidities and medications that rule out the subject
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Hyperoxygenation active treatment

    The HYPEROXYGENATED ENVIRONMENT protocol will include a single exposure to hyperoxic environment. The session will last 60 minutes, of 100% oxygen inhalation by mask at 2 ATA. 15 minutes after reaching 2 ATA and breathing 100% oxygen - IMTP test - For measurement of peak-force at baseline and under the different oxygenation conditions, each participant will be given three attempts at every IMTP test. A three-minute rest will be given between attempts, with the aim of attaining optimal recovery

    Device: Hyperbaric Oxygen Therapy - HBOT

  • Sham comparator
    Sham

    The Sham protocol will include a single session of breathing 21% oxygen by mask while in the same multi-place chamber. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 55 minutes. 15 minutes after reaching 1.03 ATA and breathing 21% oxygen - IMTP test - For measurement of peak-force at baseline and under the different oxygenation conditions, each participant will be given three attempts at every IMTP test. A three-minute rest will be given between attempts, with the aim of attaining optimal recovery

    Device: Sham

Interventions

  • DeviceHyperbaric Oxygen Therapy - HBOT

    The HYPEROXYGENATED ENVIRONMENT protocol will include a single exposure to hyperoxic environment. The session will last 60 minutes, of 100% oxygen inhalation by mask at 2 ATA

  • DeviceSham

    The Sham protocol will include a single session of breathing 21% oxygen by mask while in the same multi-place chamber. SHAM pressure will go up to 1.2 ATA during the first five minutes of the session (to simulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 55 minutes

05

What researchers measure

Primary outcomes

  1. Maximal static muscle force production

    Participants will perform the isometric mid-thigh pull (IMTP) test using an analog dynamometer that will be purchased for the purpose of the study

    Time frame: Baseline evaluation, IMPT test in HBOT chamber, Approximately 4 weeks after the first visit, participants will be exposed to the opposite intervention - HOE or SHAM - and will undergo the same isometric mid-thigh pull (IMTP) test in the chamber.

06

Study locations

1 of 1 sites recruiting
  • The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center
    Zrifin, Israel
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07558928
Lead sponsor
Assaf-Harofeh Medical Center
Responsible party
Shay Efrati (Professor, Assaf-Harofeh Medical Center) — Principal investigator
First posted
Apr 30, 2026
Start date
Jan 1, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 30, 2026

Study contacts

Eldad mr Yaakobi
Contact
yaakobi.eldad@gmail.com
972-8-9779393

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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