Brief Title
Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely
Official Title
Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely
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:
Study Type
Interventional
Primary Outcome
Tolerance to hypoxia during rest and exercise in preterm and full term individuals
Secondary Outcome
Oxidative stress responses to hypoxic exercise in preterm and full term
Condition
Hypoxia
Intervention
Graded exercise testing
Study Arms / Comparison Groups
Hypoxia at rest and exercise
Description: 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)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
37
Start Date
April 2016
Completion Date
December 2018
Primary Completion Date
October 2016
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
Gender
Male
Ages
18 Years - 24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Damjan Osredkar, MD, PhD, +38615229273, [email protected]
Location Countries
Slovenia
Location Countries
Slovenia
Administrative Informations
NCT ID
NCT02780908
Organization ID
JozefSI
Responsible Party
Sponsor
Study Sponsor
Jozef Stefan Institute
Collaborators
University of Ljubljana School of Medicine, Slovenia
Study Sponsor
Damjan Osredkar, MD, PhD, Principal Investigator, University Children's Hospital Ljubljana Department of Pediatric Neurology
Verification Date
August 2016