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临床试验/NCT04305873
NCT04305873Enrolling By Invitation不适用

Effect of Exercise-induced Hypoxemia on Cytokine and Stress Hormone Responses Among Endurance-trained Athletes

Gepner Yftach1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
1
主要终点
Changes in epinephrine level

研究概览

简要总结

It is well documented that exercise-induced arterial hypoxemia (EIAH) is highly prevalent among endurance-trained athletes performing heavy intensity exercise, regardless of sex and age. Although it has been shown that a drop in arterial oxyhemoglobin saturation (SaO2) during exercise (i.e. EIAH) negatively affects aerobic capacity measures such as VO2max and time trial performance, there remains a gap in the literature as to the physiological consequences of EIAH, and specifically acute cytokines and stress-related responses to hypoxemia during exercise. Exposure to hypoxic environments in which SaO2 is reduced and exercise can each, independently, alter/activate various pro- and anti-inflammatory markers and increases stress hormones. It follows then that EIAH athletes could be more susceptible to, and encounter more frequently, episodes of elevated levels of inflammatory cytokines and an exaggerated stress response than non-EIAH athletes; however, to the best of the investigators knowledge, this is yet to be confirmed. Therefore, it is hypothesized that highly trained endurance athletes who develop EIAH will experience more pronounced increases in inflammatory cytokines and stress hormones following a bout of heavy intensity exercise compared to athletes without EIAH.

详细描述

Fifty highly trained endurance runners (men and women, age: 18-35 years) will be recruited for this study. The first testing session will serve as a screening tool to determine subject eligibility. Following the first testing sessions subjects will be divided into EIAH or non-EIAH groups based on SaO2 at VO2max (EIAH < 93%, non-EIAH > 95%; Dempsey and Wagner criteria). Subjects with intermediate SaO2 (93-95% at VO2max) values will be included in the study for correlational analyses only.

All subjects will be advised orally, and in writing, as to the nature of the experiments and will give written, informed consent to the study protocol.

Study Design & protocol:

Subjects will be asked to visit the Exercise Performance Laboratory at the Sylvan Adams Sports Institute on three occasions. During the first visit subject will perform resting pulmonary function tests (PFTs) followed by a graded exercise test to exhaustion on either a motorized-treadmill for the determination of VO2max, degree of EIAH (SaO2 at VO2max) and maximal heart rate (HRmax). On the second visit, subjects will perform PFTs, followed by a brief warm-up run for 10 min at a moderate intensity equivalent to 60% of HRmax, as obtained from the incremental test and a 30-min trial at either half-marathon pace (HM30), designed to simulate a tempo workout often practiced by endurance runners. The third visit, conducted 24 hours after the 30-min trial, will include a blood draw only.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Physically active (minimum of 50 km running/week) and maximal oxygen consumption > 55 and 50 ml/kg-1/min-1 for men and women, respectively.
  • classified as low risk based on a medical questionnaire, body mass index and non-smoking status.
  • No history of pulmonary, metabolic and/or cardiovascular disease.
  • normal pulmonary function as defined by a ≥ 80% of predicted forced vital capacity (FVC), forced expired volume in one second (FEV1) and FEV1/FVC according the American Thoracic Society standards.

排除标准

  • Smoking and/or any pulmonary, metabolic and/or cardiovascular disease.
  • maximal oxygen consumption lower than set criteria.

结局指标

主要结局

Changes in epinephrine level

时间窗: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)

Stress hormones

Changes in Cortisol level

时间窗: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)

Stress hormones

Inflammatory cytokines

时间窗: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)

Changes in Inflammatory cytokines (e.g. IL-6, IL-1b, IL-ra, IL-10)

Inflammatory cytokine

时间窗: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)

Changes in Inflammatory cytokine TNF-a

Changes in norepinephrine level

时间窗: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)

Stress hormones

次要结局

  • Changes in number of Neutrophiles(Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30))
  • Changes in number of monocytes(Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30))
  • Immune markers(Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30))
  • Changes in number of lymphocytes(Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30))

研究者

发起方
Gepner Yftach
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gepner Yftach

Principal Investigator,

Tel Aviv University

研究点 (1)

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