Effect of Ozone Therapy on Aerobic Exercise Performance

NCT ID: NCT06217549

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-12

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ozone Therapy Exercise Performance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

healthy participants

healthy, physically active people will be included the study.

Group Type EXPERIMENTAL

ozone therapy

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Şensu Dinçer

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Şensu Dinçer

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ozone therapy, performance

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.