Exercise in Prematurely Born Preadolescents to Mitigate Cardiovascular Risk and Improve Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Central Retinal Arteriolar Equivalent (CRAE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Boys and girls born prematurely (<= 32th week of gestation)
- •aged 6 to 12 years
- •informed consent provided
排除标准
- •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
研究组 & 干预措施
Exercise Training
10 weeks of exercise training
干预措施: Physical Exercise (Other)
Control Group
Control group receiving age appropriate physical activity and life style recommendations as of current guidelines.
结局指标
主要结局
Central Retinal Arteriolar Equivalent (CRAE)
时间窗: 10 weeks
Diameter of the retinal arterioles
次要结局
未报告次要终点
