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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06500910
Acronym
EXCELSIOR
Enrollment
50
Registered
2024-07-15
Start date
2024-08-12
Completion date
2025-08-12
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

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.

Interventions

OTHERPhysical Exercise

10 weeks of child-friendly physical exercise program

Sponsors

Henner Hanssen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Central Retinal Arteriolar Equivalent (CRAE)10 weeksDiameter of the retinal arterioles

Countries

Switzerland

Contacts

Primary ContactHenner Hanssen, Prof. Dr.
henner.hanssen@unibas.ch+41 61 207 47 46
Backup ContactHolger Burchert, PhD
holger.burchert@unibas.ch+41 61 207 47 27

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026