APP Rehabilitation Management and Evaluations of Cardiopulmonary Function and Motor Development in Infants With Congenital Heart Disease: a Pilot Study
Phase: NA
Conditions: Congenital Heart Disease in Children, Infant Development, Infant Conditions, Motor Neuropathy, Motor Delay, Cardiopulmonary
Sponsor: Gejingwa Zhao

 
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The study protocol of APP rehabilitation 
management 
and 
evaluations 
of 
cardiopulmonary function and motor 
development in infants with congenital 
heart disease  
 
August 13th, 2022 
 
 
 
 
 
 
 
 

 
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·Participants  
Home-based rehabilitation of CHD patients was a randomized controlled trial 
conducted at Beijing Children’s Hospital in the year of 2021-2022, aimed at 
evaluating the prognosis of growth developmental and cardiopulmonary 
function in CHD infants (aged 4-8 months) with atrial septum defect (ASD) or 
ventricular septum defect (VSD). Patients with chromosomal abnormalities 
and 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 were 
excluded. This pilot study protocol was approved by Capital Medical 
University; Beijing Children’s Hospital. All study volunteers provided written 
informed consent.  
·Study design  
Eligible participants were randomized by a 1:1 allocation ration by computer 
either to the recovery group or control group. Upon initial enrollment, weight, 
height, body mass index (BMI), LVEF was counted, and the developmental 
evaluation was conducted in both groups before surgery. We recorded their 
Alberta and Developmental quotient (DQ) including 5 scale zones, changes of 
real-time HR during tests. To be specific, resting HR, HR in 1,3,5,10min (Max 
HR) during exercise was captured, and also being recorded 3,5,7min after the 
assessing test. By simplifying the data of HR, we calculated their rHRI at 
3,5,10min; while rHRR at 3,5,7min after exercise and define the mean value 
as their final indicators11: rHRI(x)min=(HRxmin-HRresting)/X; rHRR(x)min=(HRxmin- 
HRMax)/X. In contrast to rHRR, rHRI is negatively correlated with VO2max. A 
fast rHRI and slow rHRR represent poor aerobic endurance11. All 
assessments were repeated at 1, 3 and 6 months after the surgery.  
·Procedures  
LVEF were recorded according to preoperative cardiac ultrasound results. 
Alberta test and Neuro-intelligence Scale were performed by doctors from 

 
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healthcare department before surgery. While exercising, the patients’ resting 
HR, rHRI and rHRR were monitored by a wearable device in real time. For the 
recovery group, parents were told to keep this device to connect with our  
Rehabilitation Management APP on their cellphones, signed up and created a 
file for their children. This application, which developed by Wenxin 
Technology, provided a platform for two-way feedback between patients and 
physicians. Parents were instructed to upload children’s information of each- 
time training at home. Remote data transmitted the ultrasound result, Alberta 
and DQ, customized advice for exercising to each patient’s account. At the 
same time, doctors could also monitor the training status individually. The 
inner page includes home care guidance for CHD children, feeding 
recommendations, exercise instructions, immunization advice, etc. One month 
after surgery, there were no specific training plans for all patients. Different 
training regimens were created for each of patients in recovery group between 
1-3 months and 3-6 months following the procedure in accordance with the 
findings of the developmental evaluation and cardiac ultrasound. Parents 
were told to assist their children with certain exercises and complete a set 
amount of training time. Adverse events like sweating, cyanosis and dyspnea 
were noted. Training motions included sitting balance, hand support, crawling 
and squatting training12-14 were scheduled for 1 to 3 months postoperatively, 
moreover, climbing over obstacles was for 3 to 6 months. Defining that 
primary endpoint as the baseline-to-six-month difference in cardiopulmonary 
capacity and physical fitness between the recovery and control group.  
Statistical analysis  
Student t and Wilcoxon tests were used to evaluate between-group 
differences with respect to baseline characteristics. A p value of 0.05 was 
considered significant for all tests. Repeated measures ANCOVA was applied 
with change from baseline as the dependent variable, and recovery 
intervention, time, the rehabilitation multiplied by time interaction as 
independent variables. Moreover, Spearman test was also applied to find out 
the correlations between LVEF and rHRI, rHRR respectively. All analyses 
were performed by using the R language (Version 3.6.3).  

 
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Flow diagram of study participants