Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Improvement of health related physical fitness
研究概览
简要总结
Children with congenital heart diseases (CHD) often show reduced health related physical fitness as well as limitations in gross and fine motor skills/development. Intervention programs in childhood are still rare and often focus just on the improvement of cardiac outcomes or exercise capacity. Web-based interventions, as a useful alternative to training manuals or supervised training, are cost effective and allow a customization of training times. Primary purpose of this study is to improve health related physical fitness in children with congenital heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 10-18 years old.
- •CHD with moderate to complex severity according to the ACC criteria.
- •Health-related physical fitness <50th percentile (healthy reference).
- •German speaking.
- •internet availability and an internet-capable device to use the intervention app
- •Informed consent of parent/guardian as well as of the child.
排除标准
- •Severe Arrhythmias
- •Severe Left Heart Failure
- •Chromosomal anomalies and/or genetic syndromes.
- •Severe physical and/or sensory impairments (hearing, visual, or psychomotor).
- •Elective cardiac intervention within the next 6 months following enrollment.
结局指标
主要结局
Improvement of health related physical fitness
时间窗: at 24 weeks
The FitnessGram® is a fitness test from the Cooper Institute that assesses health-related physical fitness. It uses evidence-based standards to measure functional health status of the musculoskeletal system divided into the components muscular strength, muscular endurance and flexibility. The FitnessGram® includes tests for the upper body and the abdominal/trunk areas. Mean scores were calculated and compared to an actual reference sample of German children and adolescents.
次要结局
- Compliance with the supervised web- and home-based intervention(at 24 weeks)
- Change in Health-related Quality of Life (KINDL questionnaire)(at 24 weeks)
- Central/peripheral blood pressure(at 24 weeks)
- Pulse-wave-velocity(at 24 weeks)
- Intima media thickness(at 24 weeks)