Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease

G

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)

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.

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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