Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease

Study Overview
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Brief Summary
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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.

Official Title
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APP Rehabilitation Management and Evaluations of Cardiopulmonary Function and Motor Development in Infants With Congenital Heart Disease: a Pilot Study

Conditions
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Congenital Heart Disease in Children, Infant Development, Infant Conditions, Motor Neuropathy, Motor Delay, Cardiopulmonary

Intervention / Treatment
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* Behavioral: exercise-guidance on rehab APP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CHD infants (aged 4-8 months) with atrial septum defect (ASD) or ventricular septum defect (VSD) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 8 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recovery group<br>Recovery group was given home-based rehab exercise periodically supervised by cellphone APP. 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. | Behavioral: exercise-guidance on rehab APP<br>* 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.<br>|
| No Intervention: Control group<br>General post-operative care for 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline LVEF | Left ventricular ejection fraction before surgery | pre-operative for baseline assessment | 
| Baseline rHRI | The rate of increase in heart rate before surgery | pre-operative for baseline assessment | 
| Baseline rHRR | The rate of recovery heart rate before surgery | pre-operative for baseline assessment | 
| Baseline Alberta score | Alberta motor test results before surgery | pre-operative for baseline assessment | 
| Baseline Neuro-intelligence Scale | Developmental Quotient (DQ) before surgery | pre-operative for baseline assessment | 
| LVEF one month after the surgery | Left ventricular ejection fraction one month after the surgery | one month after surgery | 
| rHRI one month after the surgery rHRI one month after the surgery | The rate of increase in heart rate one month after the surgery | one month after surgery | 
| rHRR one month after the surgery | The rate of recovery heart rate one month after the surgery | one month after surgery | 
| Alberta score one month after the surgery | Alberta motor test results one month after the surgery | one month after surgery | 
| Neuro-intelligence Scale one month after the surgery | Developmental Quotient (DQ) one month after the surgery | one month after surgery | 
| LVEF three months after the surgery | Left ventricular ejection fraction three months after the surgery | three months after surgery | 
| rHRI three months after the surgery | The rate of increase in heart rate three months after the surgery | three months after surgery | 
| rHRR three months after the surgery | The rate of recovery heart rate three months after the surgery | three months after surgery | 
| Alberta score three months after the surgery | Alberta motor test results three months after the surgery | three months after surgery | 
| Neuro-intelligence Scale three months after the surgery | Developmental Quotient (DQ) three months after the surgery | three months after surgery | 
| LVEF six months after the surgery | Left ventricular ejection fraction six months after the surgery | six months after surgery | 
| rHRI six months after the surgery | The rate of increase in heart rate six months after the surgery | six months after surgery | 
| rHRR six months after the surgery | The rate of recovery heart rate six months after the surgery | six months after surgery | 
| Alberta score six months after the surgery | Alberta motor test results six months after the surgery | six months after surgery | 
| Neuro-intelligence Scale six months after the surgery | Developmental Quotient (DQ) six months after the surgery | six months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, rehab management APP, home-based exercise, cardiopulmonary endurance, motor developmental level