Intermittent Hypoxic Training (IHT) Versus Hyperbaric Oxygen Therapy (HBOT) for Aerobic Performance - Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Cardiopulmonary exercise test (CPET)
研究概览
简要总结
Comparing the effect of HBOT and IHT on aerobic performance of athletes.
详细描述
Enhanced physical performance is the goal of all professional and non-professional athletes. There are many intervention methods aim to enhance physical performance from 2 intervention related to change in the environment partial oxygen pressure have been demonstrated to have beneficial effect: IHT and HBOT.
This study offers one of the two interventions to athletes with a pre and post intervention objective evaluation of the physiological performance - Maximal exercise test for evaluating VO2MAX and ventilatory thresholds, time to exhaustion, 30 seconds Wingate test, agility test, muscle biopsy, blood tests, brain MRI, cognitive tests and exercise cognitive test.
After signing an informed consent form, eligible subjects will be randomized to one of the study groups at a ratio of 1:1. The IHT group will receive three hypoxic guided training sessions per week, according an individualized training protocol, 24 sessions in total.
The HBOT group will receive 40 daily hyperbaric sessions, five days per week. Each session will include 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes. Three times per week, as the IHT group, the HBOT group will have a guided training session, according an individualized training protocol.
Both groups, IHT and HBOT, will have the same relative intensity guided training protocols for 8 weeks, to stimulate the same exercise load. The IHT group will train for 60 minutes, 3 times a week in a normobaric hypoxia environment, at O2 concentration of 15.2% that stimulates a 2500-2600m height. The HBOT group will train for 60 minutes after the HBOT sessions, 3 times per week, in a normobaric normoxic environment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Vo2max above 3500 ml or Vo2max/kg above 50 ml/kg
- •Subjects are active aerobic athletes, training regularly more than 4 exercise sessions per week.
- •Subject willing and able to read, understand and sign an informed consent
排除标准
- •Inability to attend scheduled clinic visits and/or comply with the study protocol
- •Active malignancy
- •Active smokers
- •Previous treatment of HBOT for any reason prior to study enrollment.
- •Chest pathology incompatible with pressure changes
- •Major orthopedic injury at the past 3 months
- •Inner ear disease
- •Lung pathology
- •The inability to perform an awake brain MRI
- •Claustrophobia
- •Previous neurologic conditions (e.g., Epilepsy, Brain tumors or s/p neurosurgery etc.)
- •Comorbidities and medications that rule out the subject
研究组 & 干预措施
Hyperbaric Oxygen Therapy - HBOT
The protocol comprises of 40 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a two months' period. The HBOT group will train for 60 minutes after the HBOT sessions, 3 times per week, in a normobaric normoxic environment according to individualized training protocol
干预措施: Hyperbaric Oxygen Therapy - HBOT (Device)
Intermittent Hypoxic Training - IHT
The protocol comprises of 24 consecutive Intermittent Hypoxic Training (IHT) sessions, 3 sessions per week within a two months' period. Subjects will train according to individualized training protocol.
干预措施: Intermittent Hypoxic Training - IHT (Device)
结局指标
主要结局
Cardiopulmonary exercise test (CPET)
时间窗: Baseline, 11 weeks
CPET determines the gas exchange dynamics that is expected to change through the intervention
次要结局
- Blood test for evaluation of Telomeres length(Baseline,11 weeks, 16 weeks)
- Muscle biopsy for mitochondrial function(Baseline, 11 weeks)
- Wingate 30 seconds anaerobic test(Baseline, 11 weeks, 16 weeks)
- Blood test for evaluation of CBC(Baseline, 11 weeks, 16 weeks)
- Blood test for evaluation of mitochondrial function(Baseline,11 weeks)
- Cardiopulmonary exercise test (CPET)(8 weeks, 16 weeks)
- Time To Exhaustion(Baseline, 11 weeks, 16 weeks)
- Blood test for evaluation of HIF-1α(Baseline, 7 weeks, 8 weeks, 11 weeks, 16 weeks)
研究者
Shay Efrati
MD
Assaf-Harofeh Medical Center