Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment (EXCELSIOR)

Henner Hanssen

Status

Enrolling

Conditions

Preterm Birth

Treatments

Other: Physical Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT06500910

2023-02358

Details and patient eligibility

About

EXCELSIOR is a randomized controlled trial to investigate the effect of physical exercise on cardiovascular health in prematurely born children. Participants will be randomly allocated to either an intervention group or a control group. The intervention will receive a child-friendly physical exercise program and the control group will receive age appropriate lifestyle- and exercise recommendations.

Full description

Premature birth, i.e. the birth of babies before the 37th week of pregnancy, is an increasing challenge. Since the 1980s, medical advances such as special medication and ventilation techniques have significantly improved the chances of survival for premature babies. Worldwide, around 11% of all births are premature. Prematurity increases the risk of cardiovascular disease. Studies show that very premature babies have a significantly higher risk of heart problems. However, only little is known whether physical exercise could improve cardiovascular and cognitive function in prematurely born children.

All participants will undergo a baseline visit to assess vascular, cognitive and cardiopulmonary function. At the end of the visit, participants will be randomly allocated to either an intervention group or a control group. The intervention will receive a child-friendly physical exercise program and the control group will receive age appropriate lifestyle- and exercise recommendations. The physical exercise program is held 2-3 times per week for ten weeks targeting cardiovascular health and coordination. After 10 weeks, all participants will undergo a follow-up visit at which all measures will be repeated.

Enrollment

50 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Boys and girls born prematurely (<= 32th week of gestation)
aged 6 to 12 years
informed consent provided

Exclusion criteria

attendance of special education services related to attention disorders
colour blindness or any chronic eye disorder
being under pharmacological treatment for any mental disorder
injuries, significant motor- or other disabilities which prohibit the participation in physical exercise
visually provoked epilepsy
children for whom no informed consent is provided