Effect of Hyperoxygenated Environment on Maximal Muscle Strength (force)

Effect of Hyperoxygenated Environment on Maximal Muscle Strength in the Mid-thigh Pull Test - a Blinded, Randomized, Sham-Controlled Crossover Study

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Lifestyle
• Intervention / Treatment: Device: Hyperbaric Oxygen Therapy - HBOT; Device: Sham

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eldad mr Yaakobi; Phone Number: 972-8-9779393; Email: yaakobi.eldad@gmail.com

Study Locations

• Israel
  • Zrifin, Israel
    • Recruiting
    • The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center
    • Contact: Shai Efrati, MD; Phone Number: 972-8-9779393; Email: efratishai@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 26, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: force; gym; power lifting; imtp
• Additional Relevant MeSH Terms: Therapeutics; Respiratory Therapy; Oxygen Inhalation Therapy; Hyperbaric Oxygenation
• Other Study ID Numbers: 0131-23 ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No