Clinical trial NCT06500910: Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment
Official title: Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Birth
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Central Retinal Arteriolar Equivalent (CRAE)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie
state: Basel Stadt
Study officials:
affiliation: University of Basel
name: Holger Burchert, PhD
role: PRINCIPAL_INVESTIGATOR
References: