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NCT Number: NCT06500910

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

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.

Recruiting

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

Other

10 weeks of child-friendly physical exercise program

Other names: Sports

Primary outcomes

  1. Central Retinal Arteriolar Equivalent (CRAE)

    Time frame: 10 weeks

    Diameter of the retinal arterioles

Study contacts

Contact information is provided by the study sponsor or research team.

Henner Hanssen, Prof. Dr.

CONTACT

[email protected]

+41 61 207 47 46

Holger Burchert, PhD

CONTACT

[email protected]

+41 61 207 47 27

Sponsors and collaborators

Lead sponsor

Henner Hanssen

Other

Registry information

Acronym: EXCELSIOR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2024
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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