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

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ClinicalTrials.gov Identifier: NCT03504215
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
McGill University Health Center
University of Western Ontario, Canada
Université de Montréal
Ottawa Hospital Research Institute
University of Alberta
Information provided by (Responsible Party):
Anne-Monique NUYT, St. Justine's Hospital

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.

Condition or disease Intervention/treatment Phase
Prematurity; Extreme Other: Exercise Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Group assignments. Both groups are evaluated before and after a 14 week supervised exercise (aerobic and resistance training) intervention.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504215


Contacts
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Contact: Anik Cloutier, M.Sc. 1-514-345-1931 ext 6146 anik.cloutier@recherche-ste-justine.qc.ca
Contact: Thuy Mai Luu (Co Principal Investigator), MD 1-514-345-4931 ext 6642 anne-monique.nuyt@recherche-ste-justine.qc.ca

Locations
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Canada, Quebec
St. Justine's Hospital Recruiting
Montréal, Quebec, Canada, H3T1C5
Contact: Anik Cloutier, M.Sc.    1-514-345-4931 ext 6146    anik.cloutier@recherche-ste-justine.qc.ca   
Contact: Anne Monique Nuyt, MD    1-514-345-4931 ext 3971    anne-monique.nuyt@recherche-ste-justine.qc.ca   
Principal Investigator: Thuy Mai Luu, MD         
Principal Investigator: Anne Monique Nuyt, MD         
Sponsors and Collaborators
St. Justine's Hospital
McGill University Health Center
University of Western Ontario, Canada
Université de Montréal
Ottawa Hospital Research Institute
University of Alberta
Investigators
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Principal Investigator: Anne Monique Nuyt, MD St. Justine's Hospital

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Responsible Party: Anne-Monique NUYT, Chief of Neonatalogy and Professor of Pediatrics, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03504215     History of Changes
Other Study ID Numbers: HAPI Fit Clinical Study
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anne-Monique NUYT, St. Justine's Hospital:
extremely preterm
young adults
term
exercise capacity
pulmonary function
muscle oxygenation

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications