Effect of Ozone Therapy on Aerobic Exercise Performance
The Effect Of Major Autohemotherapy On Blood Lactate Exchange And Muscle Fatigue In Individuals Exposed To High-Intensity Physical Exercise
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedFirst Submitted
Initial submission to the registry
January 9, 2024
CompletedFirst Posted
Study publicly available on registry
January 22, 2024
CompletedJanuary 23, 2024
January 1, 2024
6 months
January 9, 2024
January 22, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
VO2max
maximum oxygen consumption, indicator of aerobic capacity, cardiopulmonary exercise tests performed twice for each participant
just before the first ozone therapy session and immediately after the last ozone therapy session
exercise duration
duration of cardiopulmonary exercise test
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).
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
just before the first ozone therapy session and immediately after the last ozone therapy session
Study Arms (1)
healthy participants
EXPERIMENTALhealthy, physically active people will be included the study.
Interventions
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.
Eligibility Criteria
You may qualify if:
- male
- healthy
- aged between 18-35 years old
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Şensu Dinçer
Istanbul, 34093, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
January 9, 2024
First Posted
January 22, 2024
Study Start
August 12, 2019
Primary Completion
January 31, 2020
Study Completion
January 31, 2020
Last Updated
January 23, 2024
Record last verified: 2024-01