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临床试验/NCT03504215
NCT03504215已完成不适用

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

St. Justine's Hospital2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2018年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
Measurement of the peak oxygen consumption before and after the physical intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnancy
  • conditions excludins individual from exercise

结局指标

主要结局

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

时间窗: 16 weeks

Respiratory exchange ratio (RER) (%)

次要结局

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

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Monique NUYT,MD

Chief of Neonatalogy and Professor of Pediatrics

St. Justine's Hospital

研究点 (2)

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