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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth
• Intervention / Treatment: Other: Physical Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henner Hanssen, Prof. Dr.; Phone Number: +41 61 207 47 46; Email: henner.hanssen@unibas.ch
• Study Contact Backup: Name: Holger Burchert, PhD; Phone Number: +41 61 207 47 27; Email: holger.burchert@unibas.ch

Study Locations

• Switzerland
  • Basel Stadt
    • Basel, Basel Stadt, Switzerland, 4052
      • Recruiting
      • Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie
      • Contact: Henner Hanssen, Prof. Dr.; Phone Number: + 41 (0)61 377 87 46; Email: henner.hanssen@unibas.ch
      • Contact: Holger Burchert, PhD; Phone Number: +41 (0) 61 207 47 27; Email: holger.burchert@unibas.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Training; 10 weeks of exercise training	Other: Physical Exercise; 10 weeks of child-friendly physical exercise program; Other Names: Sports
No Intervention: Control Group; Control group receiving age appropriate physical activity and life style recommendations as of current guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Retinal Arteriolar Equivalent (CRAE)	Diameter of the retinal arterioles	10 weeks

Collaborators and Investigators

• Sponsor: Henner Hanssen
• Investigators: Principal Investigator: Holger Burchert, PhD, University of Basel

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Estimated): August 12, 2025
• Study Completion (Estimated): August 12, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Neurocognitive Disorders; Cognition Disorders; Premature Birth; Cognitive Dysfunction
• Other Study ID Numbers: 2023-02358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No