Clinical trial NCT03504215: Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health.
Official title: Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity; Extreme
Keywords: extremely preterm
young adults
term
exercise capacity
pulmonary function
muscle oxygenation
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Western University, Canada
name: Université de Montréal
name: Ottawa Hospital Research Institute
name: University of Alberta
First posted: 2018-04-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Group assignments. Both groups are evaluated before and after a 14 week supervised exercise (aerobic and resistance training) intervention.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Measurement of the peak oxygen consumption before and after the physical intervention
timeFrame: 16 weeks
measure: Measurement of the peak oxygen consumption before and after the physical intervention
timeFrame: 16 weeks
measure: Measurement of the peak oxygen consumption before and after the physical intervention
timeFrame: 16 weeks
measure: Measurement of the peak oxygen consumption before and after the physical intervention
timeFrame: 16 weeks
measure: Measurement of the peak oxygen consumption before and after the physical intervention
timeFrame: 16 weeks
measure: Measurement of the peak oxygen consumption before and after the physical intervention
timeFrame: 16 weeks
measure: Measurement of the peak oxygen consumption before and after the physical intervention
timeFrame: 16 weeks
Secondary outcomes:
measure: Cardiac oxygen sensitive MRI (OS-MRI)
timeFrame: 18 weeks
measure: Lung regional ventilation using a 3D proton MRI ultrashort ecotime
timeFrame: 1 week
measure: Muscle oxygenation
timeFrame: 18 weeks
measure: Pulmonary function
timeFrame: 18 weeks
measure: Pulmonary function
timeFrame: 18 weeks
measure: Pulmonary function
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: St. Justine's Hospital
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Anne Monique Nuyt, MD
role: PRINCIPAL_INVESTIGATOR
References: