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

NCT ID: NCT03504215

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-02
• Study Completion Date: 2021-01-27

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:

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.

Conditions

Prematurity; Extreme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

young adults

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

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: OTHER

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

Interventions

Exercise Intervention

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Monique NUYT,MD

Chief of Neonatalogy and Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Monique Nuyt, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

St. Justine's Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37707478 (View on PubMed)

Other Identifiers

HAPI Fit Clinical Study

Identifier Type: -

Identifier Source: org_study_id