Identifying Determinants and Optimizing Rehabilitation of Physical Activity for Children After the Fontan Procedure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in the child's moderate-to-vigorous physical activity participation
研究概览
简要总结
The purpose of this study is to determine which is the most effective intervention for increasing lifestyle physical activity in Fontan patients: an education (stage of change) intervention or a physical activity (mastery experience) intervention.
详细描述
Over 100,000 Canadian children are living with congenital heart defects and approximately 1.5% of them have a univentricular heart. The Fontan procedure allows children with functionally univentricular hearts to live relatively normal lives. However, the cardiopulmonary physiology remains abnormal and chronic complications, including myocardial dysfunction, arrhythmias, pathway abnormalities, hepatic dysfunction, obstruction of the ventricular outflow tract or pulmonary veins, and pulmonary arteriovenous malformations may significantly reduce maximal exercise capacity and quality of life. Quality of life and life-long heart health are, therefore, critically important for Fontan patients as their survival depends on the continued functioning of an already sub-normal cardiopulmonary physiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have undergone a successful Fontan procedure prior to 5 years of age
- •6 to 10 years of age at the start of the study
- •sufficient cardiopulmonary function (based on pulmonary function tests prior to the standardized cardiorespiratory exercise test) for safe participation in moderate to vigorous physical activity
排除标准
- •disabilities or medical conditions that may influence physical activity participation.
结局指标
主要结局
Change in the child's moderate-to-vigorous physical activity participation
时间窗: From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)
次要结局
- Increase in health-related physical fitness(From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment))
- Achievement of age-appropriate gross motor skills(From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment))
- Change in the parents' and child's perceptions of physical activity importance, value, appropriateness and competence(From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment))
- Compliance with the intervention(From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment))
研究者
Brian McCrindle
Staff Cardiologist
The Hospital for Sick Children