Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical Exercise.
- Who it may be relevant to
- Registry conditions: Preterm Birth. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Physical Exercise
10 weeks of child-friendly physical exercise program
Primary outcome measures
- Central Retinal Arteriolar Equivalent (CRAE) [Time frame: 10 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Switzerland · 1 center
- Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie — Basel
Identifiers
NCT: NCT06500910 · 2023-02358