Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely

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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