NCT04305873

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

4.2 years

First QC Date

March 4, 2020

Last Update Submit

February 21, 2024

Conditions

Keywords

High intensity exerciseEnduranceAthletesDesaturationStress responseInflammatory markers

Outcome Measures

Primary Outcomes (5)

  • Inflammatory cytokines

    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

    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

    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

    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

    Stress hormones

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

Secondary Outcomes (4)

  • 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 lymphocytes

    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)

Study Arms (3)

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%

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \) 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, Israel

Location

Related Publications (22)

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    PMID: 23038244BACKGROUND
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    PMID: 7154893BACKGROUND
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    PMID: 9776552BACKGROUND
  • Duke JW, Stickford JL, Weavil JC, Chapman RF, Stager JM, Mickleborough TD. Operating lung volumes are affected by exercise mode but not trunk and hip angle during maximal exercise. Eur J Appl Physiol. 2014 Nov;114(11):2387-97. doi: 10.1007/s00421-014-2956-0. Epub 2014 Aug 2.

    PMID: 25085604BACKGROUND
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    PMID: 24853866BACKGROUND
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    PMID: 1400051BACKGROUND
  • Johnson BD, Weisman IM, Zeballos RJ, Beck KC. Emerging concepts in the evaluation of ventilatory limitation during exercise: the exercise tidal flow-volume loop. Chest. 1999 Aug;116(2):488-503. doi: 10.1378/chest.116.2.488.

    PMID: 10453881BACKGROUND
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    PMID: 9609779BACKGROUND
  • Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

    PMID: 16055882BACKGROUND
  • Weavil JC, Duke JW, Stickford JL, Stager JM, Chapman RF, Mickleborough TD. Endurance exercise performance in acute hypoxia is influenced by expiratory flow limitation. Eur J Appl Physiol. 2015 Aug;115(8):1653-63. doi: 10.1007/s00421-015-3145-5. Epub 2015 Mar 13.

    PMID: 25761731BACKGROUND
  • Romer LM, Dempsey JA, Lovering A, Eldridge M. Exercise-induced arterial hypoxemia: consequences for locomotor muscle fatigue. Adv Exp Med Biol. 2006;588:47-55. doi: 10.1007/978-0-387-34817-9_5.

    PMID: 17089878BACKGROUND
  • Amann M, Eldridge MW, Lovering AT, Stickland MK, Pegelow DF, Dempsey JA. Arterial oxygenation influences central motor output and exercise performance via effects on peripheral locomotor muscle fatigue in humans. J Physiol. 2006 Sep 15;575(Pt 3):937-52. doi: 10.1113/jphysiol.2006.113936. Epub 2006 Jun 22.

    PMID: 16793898BACKGROUND
  • Dempsey JA, Wagner PD. Exercise-induced arterial hypoxemia. J Appl Physiol (1985). 1999 Dec;87(6):1997-2006. doi: 10.1152/jappl.1999.87.6.1997.

    PMID: 10601141BACKGROUND
  • Constantini K, Tanner DA, Gavin TP, Harms CA, Stager JM, Chapman RF. Prevalence of Exercise-Induced Arterial Hypoxemia in Distance Runners at Sea Level. Med Sci Sports Exerc. 2017 May;49(5):948-954. doi: 10.1249/MSS.0000000000001193.

    PMID: 28009787BACKGROUND
  • Dominelli PB, Molgat-Seon Y, Griesdale DEG, Peters CM, Blouin JS, Sekhon M, Dominelli GS, Henderson WR, Foster GE, Romer LM, Koehle MS, Sheel AW. Exercise-induced quadriceps muscle fatigue in men and women: effects of arterial oxygen content and respiratory muscle work. J Physiol. 2017 Aug 1;595(15):5227-5244. doi: 10.1113/JP274068. Epub 2017 Jun 19.

    PMID: 28524229BACKGROUND
  • Richards JC, McKenzie DC, Warburton DE, Road JD, Sheel AW. Prevalence of exercise-induced arterial hypoxemia in healthy women. Med Sci Sports Exerc. 2004 Sep;36(9):1514-21. doi: 10.1249/01.mss.0000139898.30804.60.

    PMID: 15354032BACKGROUND
  • Hopkins SR, Barker RC, Brutsaert TD, Gavin TP, Entin P, Olfert IM, Veisel S, Wagner PD. Pulmonary gas exchange during exercise in women: effects of exercise type and work increment. J Appl Physiol (1985). 2000 Aug;89(2):721-30. doi: 10.1152/jappl.2000.89.2.721.

    PMID: 10926659BACKGROUND
  • Hopkins SR. Exercise induced arterial hypoxemia: the role of ventilation-perfusion inequality and pulmonary diffusion limitation. Adv Exp Med Biol. 2006;588:17-30. doi: 10.1007/978-0-387-34817-9_3.

    PMID: 17089876BACKGROUND
  • Rice AJ, Thornton AT, Gore CJ, Scroop GC, Greville HW, Wagner H, Wagner PD, Hopkins SR. Pulmonary gas exchange during exercise in highly trained cyclists with arterial hypoxemia. J Appl Physiol (1985). 1999 Nov;87(5):1802-12. doi: 10.1152/jappl.1999.87.5.1802.

    PMID: 10562625BACKGROUND

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 12, 2020

Study Start

March 1, 2020

Primary Completion

May 1, 2024

Study Completion

September 1, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations