APP Rehabilitation Management and Evaluations of Cardiopulmonary Function and Motor Development in Infants With Congenital Heart Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Baseline rHRR
研究概览
简要总结
In this single-center, randomized controlled trial, patients (4-8 months) with CHD were randomly assigned to either a recovery group (home-based rehab exercise periodically) supervised by cellphone APP or to a control group. Left ventricular ejection fractions (LVEF), the rate of increase in heart rate (rHRI), and the rate of recovery heart rate (rHRR) were measured for representing cardiopulmonary capacity. The Alberta test and Neuro-intelligence Scale were used to evaluate their motor developmental outcomes. This study verified the feasibility of this rehab method and indicated that 6-month home-based exercise training can improve cardiopulmonary endurance and motor developmental level in infant CHD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHD infants (aged 4-8 months) with atrial septum defect (ASD) or ventricular septum defect (VSD)
排除标准
- •chromosomal abnormalities; family history of mental retardation; small for gestational age and prematurity; history of perinatal asphyxia and hyperbilirubinemia; history of central nervous system disease or imaging suggestive of brain dysplasia
结局指标
主要结局
Baseline rHRR
时间窗: pre-operative for baseline assessment
The rate of recovery heart rate before surgery
Baseline Neuro-intelligence Scale
时间窗: pre-operative for baseline assessment
Developmental Quotient (DQ) before surgery
Alberta score one month after the surgery
时间窗: one month after surgery
Alberta motor test results one month after the surgery
LVEF three months after the surgery
时间窗: three months after surgery
Left ventricular ejection fraction three months after the surgery
rHRI three months after the surgery
时间窗: three months after surgery
The rate of increase in heart rate three months after the surgery
Alberta score three months after the surgery
时间窗: three months after surgery
Alberta motor test results three months after the surgery
rHRI six months after the surgery
时间窗: six months after surgery
The rate of increase in heart rate six months after the surgery
Neuro-intelligence Scale six months after the surgery
时间窗: six months after surgery
Developmental Quotient (DQ) six months after the surgery
Baseline LVEF
时间窗: pre-operative for baseline assessment
Left ventricular ejection fraction before surgery
Baseline rHRI
时间窗: pre-operative for baseline assessment
The rate of increase in heart rate before surgery
Baseline Alberta score
时间窗: pre-operative for baseline assessment
Alberta motor test results before surgery
LVEF one month after the surgery
时间窗: one month after surgery
Left ventricular ejection fraction one month after the surgery
rHRI one month after the surgery rHRI one month after the surgery
时间窗: one month after surgery
The rate of increase in heart rate one month after the surgery
Neuro-intelligence Scale three months after the surgery
时间窗: three months after surgery
Developmental Quotient (DQ) three months after the surgery
Alberta score six months after the surgery
时间窗: six months after surgery
Alberta motor test results six months after the surgery
rHRR one month after the surgery
时间窗: one month after surgery
The rate of recovery heart rate one month after the surgery
Neuro-intelligence Scale one month after the surgery
时间窗: one month after surgery
Developmental Quotient (DQ) one month after the surgery
rHRR three months after the surgery
时间窗: three months after surgery
The rate of recovery heart rate three months after the surgery
LVEF six months after the surgery
时间窗: six months after surgery
Left ventricular ejection fraction six months after the surgery
rHRR six months after the surgery
时间窗: six months after surgery
The rate of recovery heart rate six months after the surgery
次要结局
未报告次要终点
研究者
Gejingwa Zhao
Doctor, Doctor of Cardiac Surgery Department, Principal Investigator
Beijing Children's Hospital