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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03504215
Other study ID # HAPI Fit Clinical Study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2, 2018
Est. completion date January 27, 2021

Study information

Verified date November 2022
Source St. Justine's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date January 27, 2021
Est. primary completion date January 18, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 29 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada St. Justine's Hospital Montréal Quebec

Sponsors (6)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of the peak oxygen consumption before and after the physical intervention Respiratory exchange ratio (RER) (%) 16 weeks
Primary Measurement of the peak oxygen consumption before and after the physical intervention Oxygen uptake (VO2max) (mL/min) 16 weeks
Primary Measurement of the peak oxygen consumption before and after the physical intervention Carbon dioxide production (VCO2) (L/min) 16 weeks
Primary Measurement of the peak oxygen consumption before and after the physical intervention VO2peak (mL/kg/min) 16 weeks
Primary Measurement of the peak oxygen consumption before and after the physical intervention Weight (kg) 16 weeks
Primary Measurement of the peak oxygen consumption before and after the physical intervention Height (cm) 16 weeks
Primary Measurement of the peak oxygen consumption before and after the physical intervention Age (years) 16 weeks
Secondary Cardiac oxygen sensitive MRI (OS-MRI) myocardial perfusion in response to CO2 modulation 18 weeks
Secondary Lung regional ventilation using a 3D proton MRI ultrashort ecotime Parenchyma signal intensity (SI) 1 week
Secondary Muscle oxygenation Near-infrared spectroscopy (NIRS) 18 weeks
Secondary Pulmonary function Forced spirometry (FEV1, L) 18 weeks
Secondary Pulmonary function Forced spirometry (FVC, L) 18 weeks
Secondary Pulmonary function Forced spirometry (FEF25-75, L/s) 18 weeks
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