Exercise program for children born prematurely to improve heart health and cognitive function
Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment
This study is testing whether a fun exercise program can help improve heart health and thinking skills in children aged 6 to 12 who were born prematurely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University of Basel Academic / other |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Trial ID | NCT06500910 on ClinicalTrials.gov |
What this trial studies
This trial, known as EXCELSIOR, investigates the impact of a structured physical exercise program on cardiovascular health and cognitive function in children who were born prematurely. Participants aged 6 to 12 years will be randomly assigned to either an intervention group, which will engage in a child-friendly exercise program, or a control group that will receive general lifestyle recommendations. The study aims to assess the effectiveness of exercise in mitigating cardiovascular risks associated with premature birth. All participants will undergo evaluations of their vascular, cognitive, and cardiopulmonary functions before and after the 10-week intervention.
Who should consider this trial
Good fit: Ideal candidates are boys and girls aged 6 to 12 years who were born prematurely at or before the 32nd week of gestation.
Not a fit: Patients with significant motor disabilities, chronic eye disorders, or those receiving treatment for mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health and cognitive outcomes for children born prematurely.
How similar studies have performed: While there is limited research specifically on exercise for this population, similar studies have shown positive outcomes in improving health through physical activity in children.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel, Canton of Basel-City
- Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie — Basel, Canton of Basel-City, Switzerland (Recruiting)
Study contacts
- Principal investigator: Holger Burchert, PhD — University of Basel
- Study coordinator: Henner Hanssen, Prof. Dr.
- Email: henner.hanssen@unibas.ch
- Phone: +41 61 207 47 46
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.