Cytokine and Stress Hormone Responses to Exercise-induced Hypoxemia Among Endurance-trained

February 21, 2024 updated by: Gepner Yftach

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Tel Aviv University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Highly endurance trained athletes who have run a half marathon or marathon in the past.

Description

Inclusion Criteria:

  • 1) 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.
  • 2) classified as low risk based on a medical questionnaire, body mass index and non-smoking status.
  • 3) No history of pulmonary, metabolic and/or cardiovascular disease.
  • 4) 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
EIAH athletes
Athletes with arterial oxyhemoglobin saturation at maximal exercise during a graded exercise test <93%
Non-EIAH athletes
Athletes with arterial oxyhemoglobin saturation at maximal exercise during a graded exercise test >95%
Intermediate EIAH athletes
Athletes with arterial oxyhemoglobin saturation at maximal exercise during a graded exercise test of 93-95%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory cytokines
Time Frame: 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)
Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Inflammatory cytokine
Time Frame: 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 from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Changes in Cortisol level
Time Frame: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Stress hormones
Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Changes in epinephrine level
Time Frame: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Stress hormones
Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Changes in norepinephrine level
Time Frame: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Stress hormones
Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in number of Neutrophiles
Time Frame: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Changes in number of lymphocytes
Time Frame: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Changes in number of monocytes
Time Frame: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Immune markers
Time Frame: Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)
Changes in basophiles count (number of)
Changes from baseline to immediately, 2 hour and 24 hour post 30 minutes run at half marathon pace (HM30)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gepner Yftach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIAH1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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