Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely

NCT02780908 | Unknown

• 1 other identifier: JozefSI
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

This project will consist of two studies, each investigating resting and exercise cardio-respiratory responses during exposure to hypoxia in individuals born prematurely and individuals born at full term of two different age groups: Kids (10-14 yrs) and Adults (18-22 yrs).Additional study will be performed on a preterm adult cohort (15 participants) that will investigate potential differences between hypobaric and normobaric hypoxia as outlined in the following section.

Conditions

Hypoxia; Altitude Sickness; Tolerance

Outcome Measures

Primary Outcomes (2)

• Tolerance to hypoxia during rest and exercise in preterm and full term individuals

  All graded exercise tests will be performed on electromagnetically controlled cycle-ergometer Ergo Bike Premium.The participants will be required to maintain a cadence of 60·min-1 throughout the whole test. The test is terminated when the participant is unable to maintain the assigned cadence. The resting test will be performed in supine position with participants breathing normoxic air (FiO2=0.21) for 30 min and hypoxic gas for the subsequent 30-min (FiO2=0.120). During the whole protocol duration the respiration, local blood flow, ECG and EEG will be measured non-invasively. The resting test will be performed in supine position with participants breathing normoxic air (FiO2=0.21) for 30 min and hypoxic gas for the subsequent 30-min (FiO2=0.120). During the whole protocol duration the respiration, local blood flow, ECG and EEG will be measured non-invasively.

  Two year

• Cardio-respiratory control at rest in normoxia and hypoxia in preterm and full term individuals

  The resting test will be performed in supine position with participants breathing normoxic air (FiO2=0.21) for 30 min and hypoxic gas for the subsequent 30-min (FiO2=0.120). During the whole protocol duration the respiration, local blood flow, ECG and EEG will be measured non-invasively. The resting test will be performed in supine position with participants breathing normoxic air (FiO2=0.21) for 30 min and hypoxic gas for the subsequent 30-min (FiO2=0.120). During the whole protocol duration the respiration, local blood flow, ECG and EEG will be measured non-invasively.

  One year

Secondary Outcomes (4)

• Oxidative stress responses to hypoxic exercise in preterm and full term

  One year

• Sensitivity to hypoxia during rest and exercise - Richalet test

  One year

• Changes in intestinal metabolites as a result of hypoxic exposure

  One year

• Differences between normobaric and hypobaric hypoxia in preterm individuals

  Two years

Study Arms (2)

Hypoxia at rest and exercise

EXPERIMENTAL

The participants will perform a resting test, hypoxia sensitivity test and a graded exercise test to voluntary exhaustion in normoxic condition ((HYPO; FiO2=0.120 corresponding to terrestrial altitude of approx. 4000 m)

Other: Graded exercise testing; Other: Resting testing

Normoxia at rest and exercise

PLACEBO COMPARATOR

The participants will perform a resting test and a graded exercise test to voluntary exhaustion in normoxic condition ((NORM; fraction of inspired oxygen (FiO2)=0.209, placebo)

Other: Graded exercise testing; Other: Resting testing

Interventions

Graded exercise testing OTHER

All graded exercise tests will be performed on electromagnetically controlled cycle-ergometer Ergo Bike Premium. The testing protocol will commence with a 10-min resting period, to obtain the resting cardio-respiratory values, followed by a 5-min warm up at a work rate of 60 W. Thereafter the workload will increase every fourth minute by 40 W. The participants will be required to maintain a cadence of 60·min-1 throughout the whole test. The test is terminated when the participant is unable to maintain the assigned cadence.

Hypoxia at rest and exercise; Normoxia at rest and exercise

Resting testing OTHER

The resting test will be performed in supine position with participants breathing normoxic air (FiO2=0.21) for 30 min and hypoxic gas for the subsequent 30-min (FiO2=0.120). During the whole protocol duration the respiration, local blood flow, ECG and EEG will be measured non-invasively.

Hypoxia at rest and exercise; Normoxia at rest and exercise

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male individuals
• PRETERM group; gestational age: ≤ 32 weeks; gestational weight ≤ 1500 g
• CONTROL group: full term born individuals ≤ 38 weeks

You may not qualify if:

• Medication required that may interfere with the interpretation of the results
• Chronically illnesses
• Hormonal therapy
• Recent sub-standard nutritional status
• Family history of respiratiory, cardio-vascular, renal or hematological disease History of: thyroid dysfunction, renal stones, diabetes, allergies, hypertension, hypocalcaemia, uric acidaemia, lipidaemia or hyperhomocystinaemia
• History of mental illness
• Smoker within six months prior to the start of the study
• Abuse of drugs, medicine or alcohol
• Participation in another study up to two months before study onset
• No signed consent form before the onset of the experiment
• Blood donors in the past three months before the onset of the experiment
• Vegetarian and Vegans
• Migraines
• History of vestibular disorders
• Claustrophobia

Sponsors & Collaborators

• Jozef Stefan Institute: lead
• University of Ljubljana School of Medicine, Slovenia: collaborator
• University Medical Centre Ljubljana: collaborator
• University of Lausanne: collaborator
• University of Lyon: collaborator
• Lancaster University: collaborator
• University of Ljubljana: collaborator

Study Sites (2)

Jozef Stefan Institute

Ljubljana, Ljubljana, 1000, Slovenia

RECRUITING

University Children's Hospital Ljubljana Department of Pediatric Neurology

Ljubljana, Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (9)

• Debevec T, Pialoux V, Mekjavic IB, Eiken O, Mury P, Millet GP. Moderate exercise blunts oxidative stress induced by normobaric hypoxic confinement. Med Sci Sports Exerc. 2014 Jan;46(1):33-41. doi: 10.1249/MSS.0b013e31829f87ef.

  PMID: 23846158 BACKGROUND

• Debevec T, Mekjavic IB. Short intermittent hypoxic exposures augment ventilation but do not alter regional cerebral and muscle oxygenation during hypoxic exercise. Respir Physiol Neurobiol. 2012 Apr 30;181(2):132-42. doi: 10.1016/j.resp.2012.02.008. Epub 2012 Mar 2.

  PMID: 22406250 BACKGROUND

• Debevec T, Keramidas ME, Norman B, Gustafsson T, Eiken O, Mekjavic IB. Acute short-term hyperoxia followed by mild hypoxia does not increase EPO production: resolving the "normobaric oxygen paradox". Eur J Appl Physiol. 2012 Mar;112(3):1059-65. doi: 10.1007/s00421-011-2060-7. Epub 2011 Jul 7.

  PMID: 21735214 BACKGROUND

• Debevec T, Amon M, Keramidas ME, Kounalakis SN, Pisot R, Mekjavic IB. Normoxic and hypoxic performance following 4 weeks of normobaric hypoxic training. Aviat Space Environ Med. 2010 Apr;81(4):387-93. doi: 10.3357/asem.2660.2010.

  PMID: 20377142 BACKGROUND

• Debevec T, Pialoux V, Ehrstrom S, Ribon A, Eiken O, Mekjavic IB, Millet GP. FemHab: The effects of bed rest and hypoxia on oxidative stress in healthy women. J Appl Physiol (1985). 2016 Apr 15;120(8):930-8. doi: 10.1152/japplphysiol.00919.2015. Epub 2016 Jan 21.

  PMID: 26796757 BACKGROUND

• Debevec T, Simpson EJ, Macdonald IA, Eiken O, Mekjavic IB. Exercise training during normobaric hypoxic confinement does not alter hormonal appetite regulation. PLoS One. 2014 Jun 2;9(6):e98874. doi: 10.1371/journal.pone.0098874. eCollection 2014.

  PMID: 24887106 BACKGROUND

• Osredkar D, Sabir H, Falck M, Wood T, Maes E, Flatebo T, Puchades M, Thoresen M. Hypothermia Does Not Reverse Cellular Responses Caused by Lipopolysaccharide in Neonatal Hypoxic-Ischaemic Brain Injury. Dev Neurosci. 2015;37(4-5):390-7. doi: 10.1159/000430860. Epub 2015 Jun 12.

  PMID: 26087775 BACKGROUND

• Osredkar D, Thoresen M, Maes E, Flatebo T, Elstad M, Sabir H. Hypothermia is not neuroprotective after infection-sensitized neonatal hypoxic-ischemic brain injury. Resuscitation. 2014 Apr;85(4):567-72. doi: 10.1016/j.resuscitation.2013.12.006. Epub 2013 Dec 19.

  PMID: 24361672 BACKGROUND

• Debevec T, Pialoux V, Poussel M, Willis SJ, Martin A, Osredkar D, Millet GP. Cardio-respiratory, oxidative stress and acute mountain sickness responses to normobaric and hypobaric hypoxia in prematurely born adults. Eur J Appl Physiol. 2020 Jun;120(6):1341-1355. doi: 10.1007/s00421-020-04366-w. Epub 2020 Apr 8.

  PMID: 32270264 DERIVED

MeSH Terms

Conditions

Hypoxia; Altitude Sickness

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Damjan Osredkar, MD, PhD

  University Children's Hospital Ljubljana Department of Pediatric Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damjan Osredkar, MD, PhD

CONTACT

+38615229273; damjan.osredkar@kclj.si

Tadej Debevec, PhD

CONTACT

+38641278954; tadej.debevec@ijs.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 24, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2018
• Last Updated: August 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2)