Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely
NCT02780908 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2016-08-30
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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