Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease

Not Applicable

Completed

• Conditions: Infant Conditions; Infant Development; Cardiopulmonary; Motor Neuropathy; Congenital Heart Disease in Children; Motor Delay
• Interventions: Behavioral: exercise-guidance on rehab APP

• Registration Number: NCT05518136
• Lead Sponsor: Gejingwa Zhao

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-10
• Primary Completion: 2021-12-28
• Study Completion: 2022-05-25
• Status Verified: 2022-08
• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-24
• Last Update Submitted: 2022-08-24
• Study First Posted: 2022-08-26
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recovery group	exercise-guidance on rehab APP	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Children's Hospital; 🇨🇳 Beijing, Beijing, China