Healthy LifestyleforceNCT07558928
Effect of Hyperoxygenated Environment on Maximal Muscle Strength
A study testing Hyperbaric Oxygen Therapy - HBOT in people with Healthy Lifestyle, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
comparing the effect of hyperoxygenated environment on maximal muscle strength in the Mid-thigh Pull Task Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- Hyperbaric Oxygen Therapy - HBOT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center
Zrifin
Shai Efrati, MD, 972-8-9779393, efratishai@outlook.com
About this study
Official title: 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
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.
- Conditions
- Healthy Lifestyle
- Being tested
- Hyperbaric Oxygen Therapy - HBOT, Sham
- Keywords
- power lifting, gym, force, imtp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen Therapy - HBOTDevice
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shay Efrati, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558928
- Sponsor's protocol ID
- 0131-23 ASF
- Acronym
- force
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperoxygenated Environment on Maximal Muscle Strength in the Mid-thigh Pull Test - a Blinded, Randomized, Sham-Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT07558928
- Acronym / sponsor ID
- force / 0131-23 ASF
- Conditions
- Healthy Lifestyle
- Keywords
- power lifting, gym, force, imtp
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
comparing the effect of hyperoxygenated environment on maximal muscle strength in the Mid-thigh Pull Task
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hyperoxygenation active treatment | Active comparator | Device: Hyperbaric Oxygen Therapy - HBOTThe 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 |
| Sham | Sham comparator | Device: ShamThe 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen Therapy - HBOTThe 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 | Device | Hyperoxygenation active treatment |
| ShamThe 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 | Device | Sham |
Primary outcome
Maximal static muscle force production
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.
Participants will perform the isometric mid-thigh pull (IMTP) test using an analog dynamometer that will be purchased for the purpose of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy - HBOT in people with Healthy Lifestyle, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eldad mr Yaakobi (972-8-9779393, yaakobi.eldad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal static muscle force production (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.