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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-12

Study Completion Date

2025-08-12

Brief Summary

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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.

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Detailed Description

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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

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise Training

10 weeks of exercise training

Group Type EXPERIMENTAL

Physical Exercise

Intervention Type OTHER

10 weeks of child-friendly physical exercise program

Control Group

Control group receiving age appropriate physical activity and life style recommendations as of current guidelines.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical Exercise

10 weeks of child-friendly physical exercise program

Intervention Type OTHER

Other Intervention Names

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Sports

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes