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临床试验/NCT06217549
NCT06217549已完成不适用

The Effect Of Major Autohemotherapy On Blood Lactate Exchange And Muscle Fatigue In Individuals Exposed To High-Intensity Physical Exercise

Istanbul University2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2019年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
exercise duration

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • aged between 18-35 years old

排除标准

  • 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.

结局指标

主要结局

exercise duration

时间窗: just before the first ozone therapy session and immediately after the last ozone therapy session

duration of cardiopulmonary exercise test

Modified Borg Scale

时间窗: just before the first ozone therapy session and immediately after the last ozone therapy session

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).

Lactate levels

时间窗: just before the first ozone therapy session and immediately after the last ozone therapy session

lactate levels at the end of the each 3-minute grades of each cardiopulmonary exercise tests

VO2max

时间窗: just before the first ozone therapy session and immediately after the last ozone therapy session

maximum oxygen consumption, indicator of aerobic capacity, cardiopulmonary exercise tests performed twice for each participant

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Şensu Dinçer

medical doctor

Istanbul University

研究点 (2)

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