An interventional study of ozone therapy in Ozone Therapy and Exercise Performance, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by Istanbul University · Not applicable, Interventional, and Other
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:
Researchers compared the before and after treatment performance and recovery data.
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).
Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
healthy, physically active people will be included the study.
Other: ozone therapy
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 applied to the participants 10 sessions by the intravenous method.
VO2max
maximum oxygen consumption, indicator of aerobic capacity, cardiopulmonary exercise tests performed twice for each participant
Time frame: just before the first ozone therapy session and immediately after the last ozone therapy session
exercise duration
duration of cardiopulmonary exercise test
Time frame: just before the first ozone therapy session and immediately after the last ozone therapy session
Modified Borg Scale
Modified Borg Scale is used to measure the perceived fatigue level. The participants were asked to rate their perceived fatigue on a scale of 1-10. It was expressed as 1 'no fatigue' and 10 'extreme fatigue (exhaustion).
Time frame: just before the first ozone therapy session and immediately after the last ozone therapy session
Lactate levels
lactate levels at the end of the each 3-minute grades of each cardiopulmonary exercise tests
Time frame: just before the first ozone therapy session and immediately after the last ozone therapy session
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Istanbul University