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

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.

Study Overview

• Status: Completed
• Conditions: Prematurity; Extreme
• Intervention / Treatment: Other: Exercise Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T1C5
      • St. Justine's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: young adults; Both young adults born preterm (n=60) and term (n=30) will undergo the exercise intervention.	Other: Exercise Intervention; Assigned intervention : 14-week supervised intervention of aerobic and resistance training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the peak oxygen consumption before and after the physical intervention	Respiratory exchange ratio (RER) (%)	16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention	Oxygen uptake (VO2max) (mL/min)	16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention	Carbon dioxide production (VCO2) (L/min)	16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention	VO2peak (mL/kg/min)	16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention	Weight (kg)	16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention	Height (cm)	16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention	Age (years)	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac oxygen sensitive MRI (OS-MRI)	myocardial perfusion in response to CO2 modulation	18 weeks
Lung regional ventilation using a 3D proton MRI ultrashort ecotime	Parenchyma signal intensity (SI)	1 week
Muscle oxygenation	Near-infrared spectroscopy (NIRS)	18 weeks
Pulmonary function	Forced spirometry (FEV1, L)	18 weeks
Pulmonary function	Forced spirometry (FVC, L)	18 weeks
Pulmonary function	Forced spirometry (FEF25-75, L/s)	18 weeks

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Collaborators: University of Alberta; McGill University Health Centre/Research Institute of the McGill University Health Centre; Ottawa Hospital Research Institute; Western University, Canada; Université de Montréal
• Investigators: Principal Investigator: Anne Monique Nuyt, MD, St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2018
• Primary Completion (Actual): January 18, 2021
• Study Completion (Actual): January 27, 2021

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: exercise capacity; young adults; pulmonary function; muscle oxygenation; extremely preterm; term
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: HAPI Fit Clinical Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No