NCT07558928

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jan 2024

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

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Study Timeline

Key milestones and dates

Study Progress59%
Jan 2024Dec 2027

Study Start

First participant enrolled

January 1, 2024

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

April 16, 2026

Last Update Submit

April 26, 2026

Conditions

Keywords

power liftinggymforceimtp

Outcome Measures

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

    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.

Study Arms (2)

Hyperoxygenation active treatment

ACTIVE COMPARATOR

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

SHAM COMPARATOR

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

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

Hyperoxygenation active treatment
ShamDEVICE

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

Sham

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Inability to attend scheduled clinic visits or comply with the study protocol
  • Active malignancy
  • Active smokers
  • Previous treatment of hyperbaric chamber 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
  • 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

Zrifin, Israel

RECRUITING

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
the participants, investigators and outcome assessors will be blinded from the group allocation
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Eligible participants will be randomized to one of the study groups at a 1:1 ratio : Group-1: HYPEROXYGENATED ENVIRONMENT (HOE) first, SHAM second. Group-2: SHAM first, HYPEROXYGENATED ENVIRONMENT (HOE) second.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 30, 2026

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations