Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease

Gejingwa Zhao

Status: Completed

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

Treatments: Behavioral: exercise-guidance on rehab APP

Study type: Interventional

Funder types: Other

Identifiers

NCT05518136

Beijing Children's Hospital

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 4 to 8 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Recovery group

Experimental group

Description:

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.

Treatment:

Behavioral: exercise-guidance on rehab APP

Control group

No Intervention group

Description:

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.