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

Primary Purpose

Prematurity; Extreme

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prematurity; Extreme focused on measuring extremely preterm, young adults, term, exercise capacity, pulmonary function, muscle oxygenation

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Justine's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

young adults

Arm Description

Both young adults born preterm (n=60) and term (n=30) will undergo the exercise intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2018
Last Updated
November 2, 2022
Sponsor
St. Justine's Hospital
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre, Western University, Canada, Université de Montréal, Ottawa Hospital Research Institute, University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03504215
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
January 18, 2021 (Actual)
Study Completion Date
January 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre, Western University, Canada, Université de Montréal, Ottawa Hospital Research Institute, University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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. Compare the response of the above measures to exercise intervention between young adults born very preterm and term controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity; Extreme
Keywords
extremely preterm, young adults, term, exercise capacity, pulmonary function, muscle oxygenation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
young adults
Arm Type
Experimental
Arm Description
Both young adults born preterm (n=60) and term (n=30) will undergo the exercise intervention.
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Assigned intervention : 14-week supervised intervention of aerobic and resistance training.
Primary Outcome Measure Information:
Title
Measurement of the peak oxygen consumption before and after the physical intervention
Description
Respiratory exchange ratio (RER) (%)
Time Frame
16 weeks
Title
Measurement of the peak oxygen consumption before and after the physical intervention
Description
Oxygen uptake (VO2max) (mL/min)
Time Frame
16 weeks
Title
Measurement of the peak oxygen consumption before and after the physical intervention
Description
Carbon dioxide production (VCO2) (L/min)
Time Frame
16 weeks
Title
Measurement of the peak oxygen consumption before and after the physical intervention
Description
VO2peak (mL/kg/min)
Time Frame
16 weeks
Title
Measurement of the peak oxygen consumption before and after the physical intervention
Description
Weight (kg)
Time Frame
16 weeks
Title
Measurement of the peak oxygen consumption before and after the physical intervention
Description
Height (cm)
Time Frame
16 weeks
Title
Measurement of the peak oxygen consumption before and after the physical intervention
Description
Age (years)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Cardiac oxygen sensitive MRI (OS-MRI)
Description
myocardial perfusion in response to CO2 modulation
Time Frame
18 weeks
Title
Lung regional ventilation using a 3D proton MRI ultrashort ecotime
Description
Parenchyma signal intensity (SI)
Time Frame
1 week
Title
Muscle oxygenation
Description
Near-infrared spectroscopy (NIRS)
Time Frame
18 weeks
Title
Pulmonary function
Description
Forced spirometry (FEV1, L)
Time Frame
18 weeks
Title
Pulmonary function
Description
Forced spirometry (FVC, L)
Time Frame
18 weeks
Title
Pulmonary function
Description
Forced spirometry (FEF25-75, L/s)
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Monique Nuyt, MD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Justine's Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada

12. IPD Sharing Statement

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

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