Clinical trial NCT06217549: Effect of Ozone Therapy on Aerobic Exercise Performance
Official title: The Effect Of Major Autohemotherapy On Blood Lactate Exchange And Muscle Fatigue In Individuals Exposed To High-Intensity Physical Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ozone Therapy
Exercise Performance
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to investigate the effect of the ozone therapy applied using the major autohemotherapy method on exercise performance in male healthy individuals.

The main question's aims to answer are:

* Is ozone therapy applied with the major autohemotherapy method increase the performance?
* Is ozone therapy applied with the major autohemotherapy method improve the recovery after exercise?
* Participants are asked to continue the same exercise program throughout the study. They were given 10 sessions of ozone therapy over 6 weeks.

Researchers compared the before and after treatment performance and recovery data.

Detailed description: Medical ozone is a mixture of pure ozone gas (0.05-5%) and pure oxygen (99.95-95%). It is produced from pure medical oxygen by medical ozone generators. It is suggested that ozone therapy, which is used to treat a wide variety of diseases and is especially useful in the treatment of tissue ischemia and cardiovascular disorders, creates a mild, temporary and controlled oxidative stress and modulates the antioxidant system and immune system. It was reported that ozone exerted its effects by induction of reactive oxygen species and lipid oxygen products known as ozonides. The therapy modulates the immune system by balancing inflammatory and anti-inflammatory cytokines, increasing antioxidant enzymes and increasing glutathione production. In addition, it increases the production of 2,3-diphosphoglycerate (2,3-DPG) by causing an increase in the rate of red blood cell (RBC) glycolysis, improves red cell rheology, increases the oxidative carboxylation of pyruvate, and activates the hexose monophosphate pathway by stimulating adenosine triphosphate (ATP) production. With a decrease in potential of hydrogen (pH) and a slight increase in 2,3-DPG, the sigmoid curve of oxyhemoglobin shifts to the right due to the Bohr effect. The shift to the right reduces the chemical binding of oxygen to hemoglobin, facilitating oxygen delivery to ischemic tissues. Considering that the most important determinant of exercise performance is tissue oxygenation and that the antioxidant system has a positive effect on fatigue, these data lead to the idea that ozone can improve exercise performance.

There are a few studies in the literature investigating the effect of major ozone treatment on exercise performance. The arguments suggesting that major ozone therapy is effective in exercise performance are based on publications made outside of this subject, which include the mechanism of action of major ozone therapy.

Thus, it was aimed to evaluate the effects of the ozone therapy applied using the major autohemotherapy method on exercise performance with changes in fatigue, exercise duration, blood lactate changes level, anaerobic threshold, and maximal oxygen consumption (VO2max).

Eligibility criteria: Inclusion Criteria:

* male
* healthy
* aged between 18-35 years old

Exclusion Criteria:

* suffering from a low back or lower extremity injury or surgical operation in the last one year
* having cardiovascular disease
* having glucose 6 phosphate dehydrogenase enzyme deficiency
* having chronic metabolic disease
* having hyperthyroidism, mental and psychological problems.

Primary outcomes:
measure: VO2max
timeFrame: just before the first ozone therapy session and immediately after the last ozone therapy session
measure: exercise duration
timeFrame: just before the first ozone therapy session and immediately after the last ozone therapy session
measure: Modified Borg Scale
timeFrame: just before the first ozone therapy session and immediately after the last ozone therapy session
measure: Lactate levels
timeFrame: just before the first ozone therapy session and immediately after the last ozone therapy session
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Şensu Dinçer
Study officials:
References: