Clinical trial NCT02780908: Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely
Official title: Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia
Altitude Sickness
Tolerance
Lead sponsor: Jozef Stefan Institute
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
name: University Medical Centre Ljubljana
name: University of Lausanne
name: University of Lyon
name: Lancaster University
name: University of Ljubljana
First posted: 2016-05-24
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The study protocol in each age group will comprise two visits to the laboratory testing sessions in a randomized order. On one occasion the participants will perform a resting hypoxia test and a graded exercise test to voluntary exhaustion in normoxic condition ((NORM; fraction of inspired oxygen (FiO2)=0.209, placebo). On a second visit the participants will perform a hypoxia sensitivity test and a graded exercise test to voluntary exhaustion in hypoxic condition (HYPO; FiO2=0.120 corresponding to terrestrial altitude of approx. 4000 m). Indirect calorimetry, near infrared spectroscopy and ECG measurements will be performed throughout all tests. During both testing sessions the participants will also undergo anthropometry measurements and pulmonary function testing. The outline of the research visits is presented in the bellow figure:

Eligibility criteria: Inclusion Criteria:

Healthy male individuals

PRETERM group; gestational age: ≤ 32 weeks; gestational weight ≤ 1500 g

CONTROL group: full term born individuals ≤ 38 weeks

Exclusion Criteria:

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

Primary outcomes:
measure: Tolerance to hypoxia during rest and exercise in preterm and full term individuals
timeFrame: Two year
measure: Cardio-respiratory control at rest in normoxia and hypoxia in preterm and full term individuals
timeFrame: One year
Secondary outcomes:
measure: Oxidative stress responses to hypoxic exercise in preterm and full term
timeFrame: One year
measure: Sensitivity to hypoxia during rest and exercise - Richalet test
timeFrame: One year
measure: Changes in intestinal metabolites as a result of hypoxic exposure
timeFrame: One year
measure: Differences between normobaric and hypobaric hypoxia in preterm individuals
timeFrame: Two years
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Jozef Stefan Institute
city: Ljubljana
country: Slovenia
facility: University Children's Hospital Ljubljana Department of Pediatric Neurology
Study officials:
affiliation: University Children's Hospital Ljubljana Department of Pediatric Neurology
name: Damjan Osredkar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.