On-Line Intervention to Lower Cardiovascular Risk in Pediatric Heart Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in Endothelial Pulse Amplitude Testing Index
研究概览
简要总结
Pediatric heart transplant patients have a high-risk cardiovascular profile affecting their long-term outcomes and survival. Currently, no effective cardiovascular preventative care is provided for this pediatric population, in part, due to the fact that clinic-based programs are not easily accessible to children and their families. However, tele-health has been show to improve medical outcomes by making care more accessible to these patients. This study aims to meet the urgent need for an effective and sustainable delivery of preventative care to pediatric heart transplant patients using a diet and exercise intervention program delivered live over the internet direct to these patients' homes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart transplant >11 months before baseline visit
- •Able to fast overnight
- •Cardiac clearance to exercise by the primary cardiologist
- •Presence of an adult at home during the exercise training sessions for patients < 14 years of age
排除标准
- •Acute illness
- •Latex allergy
- •Document transplant rejection < 3 months
- •Re-transplantation or multi-organ transplantation
- •Malignancy
研究组 & 干预措施
On-Line Diet and Exercise Intervention
干预措施: On-Line Diet and Exercise Intervention (Other)
结局指标
主要结局
Change in Endothelial Pulse Amplitude Testing Index
时间窗: Baseline, 16 weeks, and 32 weeks
Test of endothelial function
次要结局
- Arterial Tonometry(Baseline, 16 weeks, and 32 weeks)
- Carotid Artery Imaging(Baseline, 16 weeks, and 32 weeks)
- Fasting Low-Density Lipoprotein Level(Baseline, 16 weeks, and 32 weeks)
- Volume of Oxygen Consumed at Maximal Exertion(Baseline, 16 weeks, and 32 weeks)
- Physical and Psychosocial Health Questionnaire Scores(Baseline, 16 weeks, and 32 weeks)
- Functional Movement Screening Score(Baseline, 16 weeks, and 32 weeks)
研究者
Seda Tierney
Principal Investigator
Stanford University