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Clinical Trials/NCT03504215
NCT03504215
Completed
Not Applicable

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

St. Justine's Hospital1 site in 1 country68 target enrollmentMarch 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prematurity; Extreme
Sponsor
St. Justine's Hospital
Enrollment
68
Locations
1
Primary Endpoint
Measurement of the peak oxygen consumption before and after the physical intervention
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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: 1. 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. 2. 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. 3. Compare the response of the above measures to exercise intervention between young adults born very preterm and term controls.

Registry
clinicaltrials.gov
Start Date
March 2, 2018
End Date
January 27, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
St. Justine's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Anne Monique NUYT,MD

Chief of Neonatalogy and Professor of Pediatrics

St. Justine's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Measurement of the peak oxygen consumption before and after the physical intervention

Time Frame: 16 weeks

Age (years)

Secondary Outcomes

  • Cardiac oxygen sensitive MRI (OS-MRI)(18 weeks)
  • Pulmonary function(18 weeks)
  • Lung regional ventilation using a 3D proton MRI ultrashort ecotime(1 week)
  • Muscle oxygenation(18 weeks)

Study Sites (1)

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