The Effect of Hyperbaric Oxygen Therapy on Aerobic and Anaerobic Physical Fitness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change from baseline of exercise VO2 MAX at 2 months and 4 months
研究概览
简要总结
Previous evidence showed hyperbaric oxygen can enhance aerobic and anaerobic performance during the exposure. The effect of continuous exposure of hyperbaric oxygen on performance was never evaluated.
详细描述
In recent years, several options for physical performance enhancement by increasing blood oxygen content were explored. One option is increasing the number of red blood cells by blood transfusions. Another option is using the erythropoietin hormone. These methods showed an effective increase of maximal oxygen consumption rate (VO2MAX) by 10%. However, due to their inherent risks, the international sports associations banned their uses. A third option of training in high altitude environments, but this option was never proved to be effective.
Another strategy would be increasing the blood oxygen content by increasing the plasma dissolved oxygen concentration. This would only be possible using hyperbaric oxygen therapy -which includes inhaling 100% oxygen in a pressure higher than the normal atmospheric pressure.
Previous evidence showed hyperbaric oxygen can enhance aerobic and anaerobic performance during the exposure. These studies evaluated the effect during a single hyperbaric oxygen exposure. The effect of continuous exposure of hyperbaric oxygen on performance was never evaluated.
The study is designed as a randomized controlled study aiming to evaluate the therapeutic effects of hyperbaric oxygen therapy (HBOT) on the aerobic and anaerobic performance.
After signing an informed consent form, patients will be randomized into 2 groups: treatment and control group. Patients will be invited for baseline evaluations. All patients would be evaluated 2 times - at baseline and after 2 months of follow up, The evaluation will include physical examination, VO2MAX, muscle biopsy for mitochondrial function, aerobic function measurements, cognitive assessment, brain MRI, brain EEG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-25 or 40-50 age
- •Professional performance of aerobic sports for ages 18-25 (at least 5 times a week)
- •Moderate and above performance of aerobic sports for ages 40-50 (at least 4 times a week)
- •no chronic illness
- •no significant musculoskeletal injury in the past 3 months
排除标准
- •Debilitating significant musculoskeletal injury
- •Previous hyperbaric oxygen exposure
- •Lung pathology
- •Middle or Inner ear pathology
- •Claustrophobia
- •Chronic illness
- •Chronic medications
研究组 & 干预措施
Control/Crossover
SHAM therapy: 2 months of treatment consisting of 40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week
干预措施: SHAM treatment (Device)
结局指标
主要结局
Change from baseline of exercise VO2 MAX at 2 months and 4 months
时间窗: baseline, at 2 months, 4 months
Using a standard exercise test which includes gas analysis, the change in VO2 maxs will be assessed 2 months and 4 months compared to baseline
次要结局
- Change in forced volume capacity (FVC)(baseline, at 2 months, at 4 months)
- Change from baseline of respiration independent adenosine triphosphate (ATP) production (in muscle biopsy(baseline, at 2 months, at 4 months)
- Change in maximal vertical jump (meters)(baseline, at 2 months, at 4 months)
- Change in forced expiratory volume at one second (FEV1)(baseline, at 2 months, at 4 months)
- Change from baseline of maximal respiratory rate(baseline, at 2 months, at 4 months)
- Change in general cognitive function(baseline, at 2 months, at 4 months)
- Change in maximal running speed (km/hr)(baseline, at 2 months, at 4 months)
- Change from baseline of brain blood perfusion in brain MRI(baseline, at 2 months, at 4 months)
- Change from baseline of basal respiration rate(baseline, at 2 months, at 4 months)
- Change from baseline in body fat/muscle ratio(baseline, at 2 months, at 4 months)
研究者
Assaf Harofeh MC
MD
Assaf-Harofeh Medical Center