NCT03504215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2021

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

2.9 years

First QC Date

April 10, 2018

Last Update Submit

November 2, 2022

Conditions

Prematurity; Extreme

Keywords

extremely pretermyoung adultstermexercise capacitypulmonary functionmuscle oxygenation

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (6)

  • Cardiac oxygen sensitive MRI (OS-MRI)

    18 weeks

  • Lung regional ventilation using a 3D proton MRI ultrashort ecotime

    1 week

  • Muscle oxygenation

    18 weeks

  • Pulmonary function

    18 weeks

  • Pulmonary function

    18 weeks

  • +1 more secondary outcomes

Study Arms (1)

young adults

EXPERIMENTAL

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

Other: Exercise Intervention

Interventions

Exercise InterventionOTHER

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

young adults

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • conditions excludins individual from exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Justine's Hospital

Montreal, Quebec, H3T1C5, Canada

Location

Related Publications (1)

  • Tardif CB, Mathieu ME, Caru M, Al-Simaani A, Girard-Bock C, Cloutier A, Stickland MK, Nuyt AM, Luu TM. HAPI Fit: An Exercise Intervention to Improve Peak Aerobic Capacity in Young Adults Born Very Preterm. Med Sci Sports Exerc. 2024 Jan 1;56(1):44-52. doi: 10.1249/MSS.0000000000003279. Epub 2023 Aug 30.

    PMID: 37707478DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Anne Monique Nuyt, MD

    St. Justine's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Group assignments. Both groups are evaluated before and after a 14 week supervised exercise (aerobic and resistance training) intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Neonatalogy and Professor of Pediatrics

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 20, 2018

Study Start

March 2, 2018

Primary Completion

January 18, 2021

Study Completion

January 27, 2021

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

CA(1)