Effect of Hyperoxygenated Environment on Maximal Muscle Strength

Official title

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

Overview

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.

Interventions

• 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
• 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

Primary outcome measures

• 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.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Israel · 1 center

• The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center — Zrifin

Identifiers

NCT: NCT07558928 · 0131-23 ASF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗