Preterm BirthEXCELSIORNCT06500910
Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment
A study testing Physical Exercise in people with Preterm Birth, run by Henner Hanssen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Physical Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Aug 2024to 12 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Boys and girls born prematurely (<= 32th week of gestation)
- aged 6 to 12 years
- informed consent provided
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie
Basel, Canton of Basel-City, 4052
Henner Hanssen, Prof. Dr., + 41 (0)61 377 87 46, henner.hanssen@unibas.ch
Holger Burchert, PhD, +41 (0) 61 207 47 27, holger.burchert@unibas.ch
About this study
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.
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- Physical Exercise
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseOther
Also called Sports
10 weeks of child-friendly physical exercise program
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Experimental | 10 weeks of exercise training Receives: Other: Physical Exercise |
| Control Group | No intervention | Control group receiving age appropriate physical activity and life style recommendations as of current guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Retinal Arteriolar Equivalent (CRAE)
Diameter of the retinal arterioles
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start12 Aug 2024
- Primary completion12 Aug 2025 (estimated)
- Study completion12 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henner Hanssen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henner Hanssen, University of Basel
- Investigators
- Holger Burchert, PhD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500910
- Sponsor's protocol ID
- 2023-02358
- Other IDs
- 2023
- Acronym
- EXCELSIOR
- Status last verified
- May 2025
- First submitted
- 8 Jul 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06500910
- Acronym / sponsor ID
- EXCELSIOR / 2023-02358
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Henner HanssenUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 12 Aug 2025 (estimated)
- Study completion
- 12 Aug 2025 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Experimental | Other: Physical Exercise10 weeks of exercise training |
| Control Group | No intervention | –Control group receiving age appropriate physical activity and life style recommendations as of current guidelines. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Boys and girls born prematurely (<= 32th week of gestation)
- aged 6 to 12 years
- informed consent provided
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ExerciseAlso: Sports10 weeks of child-friendly physical exercise program | Other | Exercise Training |
Primary outcome
Central Retinal Arteriolar Equivalent (CRAE)
Time frame: 10 weeks
Diameter of the retinal arterioles
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
Related trials for Preterm Birth
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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holger Burchert, PhD principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise in people with Preterm Birth, run by Henner Hanssen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henner Hanssen, Prof. Dr. (+41 61 207 47 46, henner.hanssen@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Retinal Arteriolar Equivalent (CRAE) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.