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Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely (PreTerm)

J

Jozef Stefan Institute

Status

Unknown

Conditions

Altitude Sickness
Tolerance
Hypoxia

Treatments

Other: Resting testing
Other: Graded exercise testing

Study type

Interventional

Funder types

Other

Identifiers

NCT02780908
JozefSI

Details and patient eligibility

About

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.

Full 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:

Enrollment

37 estimated patients

Sex

Male

Ages

18 to 24 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

37 participants in 2 patient groups, including a placebo group

Hypoxia at rest and exercise
Experimental group
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)
Treatment:
Other: Graded exercise testing
Other: Resting testing
Normoxia at rest and exercise
Placebo Comparator group
Description:
The participants will perform a resting test and a graded exercise test to voluntary exhaustion in normoxic condition ((NORM; fraction of inspired oxygen (FiO2)=0.209, placebo)
Treatment:
Other: Graded exercise testing
Other: Resting testing

Trial contacts and locations

2

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Central trial contact

Tadej Debevec, PhD; Damjan Osredkar, MD, PhD

Data sourced from clinicaltrials.gov

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