Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health.

Study Overview
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Brief Summary
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In spite of advances in neonatal intensive care allowing the first generation survivors of extreme prematurity to now reach young adulthood, these individuals present with reduced exercise capacity; a strong predictor of later chronic disease and mortality. The reason why individuals born preterm have exercise limitation remains unclear and may be a consequence of impact of preterm birth and associated neonatal difficulties on the development of organs important for exercise, namely the lungs, the heart, the vessels (which bring blood and oxygen to the muscles) and the muscles. It is well known that exercise benefits overall health in at-risk as well diseased populations. However, whether exercise training can improve fitness in young adults born preterm was not demonstrated and whether the cardiovascular, pulmonary and muscle impairments associated with preterm birth are reversible through exercise intervention in young adulthood is unknown.

Detailed Description
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The investigators postulate that a 14-week exercise intervention will improve exercise capacity in preterm adults, as seen in other at-risk populations, in correlation with measures of vascular health, heart and muscle perfusion and oxygenation, and pulmonary function detected by cutting edge and highly sensitive imaging and circulating biomarkers. These markers are more sensitive to pre-disease changes than traditional health measures, and are largely unexplored in preterm populations. The investigators will: Determine whether a 14-week supervised exercise training improves exercise capacity in young adults (18-29 years old) born very preterm at <29 weeks gestational age. Examine whether improvement in exercise capacity is associated with changes in (a) markers of vascular health including circulating endothelial progenitor cells and microparticles, (b) cardiac perfusion by cutting-edge oxygenation-sensitive cardiovascular magnetic resonance imaging (MRI), (c) lung regional ventilation measured by newly developed hydrogen proton (1H) MRI, (d) muscle oxygenation during exercise. Compare the response of the above measures to exercise intervention between young adults born very preterm and term controls.

Official Title
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Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health

Conditions
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Prematurity; Extreme

Intervention / Treatment
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* Other: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both groups : Aged between 18-29 years old Less than 120 minutes of exercise per week Willingness to be part of the 14 weeks exercise intervention Preterm group: - Born under 29 weeks of gestation Term group : Born between 37-41 weeks Appropriate weight fo gestational weight Exclusion Criteria: Pregnancy conditions excludins individual from exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Group assignments. Both groups are evaluated before and after a 14 week supervised exercise (aerobic and resistance training) intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: young adults<br>Both young adults born preterm (n=60) and term (n=30) will undergo the exercise intervention. | Other: Exercise Intervention<br>* Assigned intervention : 14-week supervised intervention of aerobic and resistance training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the peak oxygen consumption before and after the physical intervention | Respiratory exchange ratio (RER) (%) | 16 weeks | 
| Measurement of the peak oxygen consumption before and after the physical intervention | Oxygen uptake (VO2max) (mL/min) | 16 weeks | 
| Measurement of the peak oxygen consumption before and after the physical intervention | Carbon dioxide production (VCO2) (L/min) | 16 weeks | 
| Measurement of the peak oxygen consumption before and after the physical intervention | VO2peak (mL/kg/min) | 16 weeks | 
| Measurement of the peak oxygen consumption before and after the physical intervention | Weight (kg) | 16 weeks | 
| Measurement of the peak oxygen consumption before and after the physical intervention | Height (cm) | 16 weeks | 
| Measurement of the peak oxygen consumption before and after the physical intervention | Age (years) | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac oxygen sensitive MRI (OS-MRI) | myocardial perfusion in response to CO2 modulation | 18 weeks | 
| Lung regional ventilation using a 3D proton MRI ultrashort ecotime | Parenchyma signal intensity (SI) | 1 week | 
| Muscle oxygenation | Near-infrared spectroscopy (NIRS) | 18 weeks | 
| Pulmonary function | Forced spirometry (FEV1, L) | 18 weeks | 
| Pulmonary function | Forced spirometry (FVC, L) | 18 weeks | 
| Pulmonary function | Forced spirometry (FEF25-75, L/s) | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extremely preterm, young adults, term, exercise capacity, pulmonary function, muscle oxygenation