Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Activity: triaxial accelerometry
研究概览
简要总结
Children with congenital heart defects have shown to develop motor coordinative deficiencies. In this study we want to show that a motor pedagogic physical training can improve the coordinative capabilities of children aged 4-6 years.
详细描述
The study will be performed with a randomized crossover design. After the first assessment of coordinative capabilities children were randomized into two groups. One starts with exercised training for three months. After midterm assessment of the capabilities they will pause for another 3 months and reassessed. The second group will start without training for the first three months. After midterm assessment they will train for three months and have their final assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •without significant residuals hemodynamically not significant
- •without significant residuals after repair
- •age 4-6 incl.
排除标准
- •gradient at coarctation site > 20 mmHg
- •gradient RVOT, PV, LVOT, or AoV > 30 mmHg
- •right-left shunt (rest or exercise)
- •left-right shunt with dilatation or failure of ana cardiac chamber
- •pulmonary hypertension
- •heart failure, necessitating therapy
- •(suspected) myocarditis or cardiomyopathy
- •significant arrhythmia
- •ion channel defects, other arrhythmic diseases
- •Fontan-like circulation
- •repair by atrial switch
- •oral anticoagulation
- •other medical problems curtailing exercise capacity
结局指标
主要结局
Activity: triaxial accelerometry
时间窗: 3 months
次要结局
- coordinative test: MOT 4-6(3 months)
- coordinative test: LOS KF 18(3 months)
- Quality of life: Kiddy-KINDL(3 months)