NCT02780908

Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Jozef Stefan Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 24 Years
• Healthy volunteers: Accepted

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:

Conditions

• Hypoxia
• Altitude Sickness
• Tolerance

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-10-01
• Completion: 2018-12-01
• First posted: 2016-05-24
• Last updated: 2016-08-30

Locations

2 sites across 1 country: Slovenia