Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment
EXCELSIOR
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2024
CompletedFirst Posted
Study publicly available on registry
July 15, 2024
CompletedStudy Start
First participant enrolled
August 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2025
CompletedMay 30, 2025
May 1, 2025
1 year
July 8, 2024
May 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Central Retinal Arteriolar Equivalent (CRAE)
Diameter of the retinal arterioles
10 weeks
Study Arms (2)
Exercise Training
EXPERIMENTAL10 weeks of exercise training
Control Group
NO INTERVENTIONControl group receiving age appropriate physical activity and life style recommendations as of current guidelines.
Interventions
10 weeks of child-friendly physical exercise program
Eligibility Criteria
You may qualify if:
- Boys and girls born prematurely (\<= 32th week of gestation)
- aged 6 to 12 years
- informed consent provided
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henner Hanssenlead
Study Sites (1)
Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie
Basel, Canton of Basel-City, 4052, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Holger Burchert, PhD
University of Basel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 8, 2024
First Posted
July 15, 2024
Study Start
August 12, 2024
Primary Completion
August 12, 2025
Study Completion
August 12, 2025
Last Updated
May 30, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share