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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03504215
Enrollment
68
Registered
2018-04-20
Start date
2018-03-02
Completion date
2021-01-27
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity; Extreme

Keywords

extremely preterm, young adults, term, exercise capacity, pulmonary function, muscle oxygenation

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.

Interventions

OTHERExercise Intervention

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

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
CollaboratorOTHER
Western University, Canada
CollaboratorOTHER
Université de Montréal
CollaboratorOTHER
Ottawa Hospital Research Institute
CollaboratorOTHER
University of Alberta
CollaboratorOTHER
St. Justine's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Group assignments. Both groups are evaluated before and after a 14 week supervised exercise (aerobic and resistance training) intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of the peak oxygen consumption before and after the physical intervention16 weeksRespiratory exchange ratio (RER) (%)

Secondary

MeasureTime frameDescription
Cardiac oxygen sensitive MRI (OS-MRI)18 weeksmyocardial perfusion in response to CO2 modulation
Lung regional ventilation using a 3D proton MRI ultrashort ecotime1 weekParenchyma signal intensity (SI)
Muscle oxygenation18 weeksNear-infrared spectroscopy (NIRS)
Pulmonary function18 weeksForced spirometry (FEV1, L)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026