Skip to main content
OpenTrials
Completed

NCT Number: NCT03504215

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Justine's Hospital

Montreal, Quebec, H3T1C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise intervention

Other

Assigned intervention : 14-week supervised intervention of aerobic and resistance training.

Primary outcomes

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

    Time frame: 16 weeks

    Respiratory exchange ratio (RER) (%)

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

    Time frame: 16 weeks

    Oxygen uptake (VO2max) (mL/min)

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

    Time frame: 16 weeks

    Carbon dioxide production (VCO2) (L/min)

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

    Time frame: 16 weeks

    VO2peak (mL/kg/min)

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

    Time frame: 16 weeks

    Weight (kg)

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

    Time frame: 16 weeks

    Height (cm)

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

    Time frame: 16 weeks

    Age (years)

Secondary outcomes

  1. Cardiac oxygen sensitive MRI (OS-MRI)

    Time frame: 18 weeks

    myocardial perfusion in response to CO2 modulation

  2. Lung regional ventilation using a 3D proton MRI ultrashort ecotime

    Time frame: 1 week

    Parenchyma signal intensity (SI)

  3. Muscle oxygenation

    Time frame: 18 weeks

    Near-infrared spectroscopy (NIRS)

  4. Pulmonary function

    Time frame: 18 weeks

    Forced spirometry (FEV1, L)

  5. Pulmonary function

    Time frame: 18 weeks

    Forced spirometry (FVC, L)

  6. Pulmonary function

    Time frame: 18 weeks

    Forced spirometry (FEF25-75, L/s)

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Ottawa Hospital Research Institute
  • University of Alberta
  • Université de Montréal
  • Western University, Canada

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2018
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.