Ignite Creation Date:
2024-07-17 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500910
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment
Sponsor:
Henner Hanssen
Organization:
University of Basel
Study Overview
Official Title:
Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXCELSIOR
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
Detailed Description:
Premature birth ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None