Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely

NCT02780908 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-08-30

No results posted yet for this study

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

Interventions

OTHER

Graded exercise testing

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.

OTHER

Resting testing

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.

Sponsors & Collaborators

  • University of Ljubljana School of Medicine, Slovenia

    collaborator OTHER
  • University Medical Centre Ljubljana

    collaborator OTHER
  • University of Lausanne

    collaborator OTHER
  • University of Lyon

    collaborator OTHER
  • Lancaster University

    collaborator OTHER
  • University of Ljubljana

    collaborator OTHER
  • Jozef Stefan Institute

    lead OTHER

Principal Investigators

  • Damjan Osredkar, MD, PhD · University Children's Hospital Ljubljana Department of Pediatric Neurology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-10-31
Completion
2018-12-31

Countries

  • Slovenia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02780908 on ClinicalTrials.gov