Skip to content

Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05518136
Enrollment
28
Registered
2022-08-26
Start date
2021-04-10
Completion date
2022-05-25
Last updated
2022-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

infant, rehab management APP, home-based exercise, cardiopulmonary endurance, motor developmental level

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.

Interventions

BEHAVIORALexercise-guidance on rehab APP

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.

Sponsors

Gejingwa Zhao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Months to 8 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Baseline LVEFpre-operative for baseline assessmentLeft ventricular ejection fraction before surgery
Baseline rHRIpre-operative for baseline assessmentThe rate of increase in heart rate before surgery
Baseline rHRRpre-operative for baseline assessmentThe rate of recovery heart rate before surgery
Baseline Alberta scorepre-operative for baseline assessmentAlberta motor test results before surgery
Baseline Neuro-intelligence Scalepre-operative for baseline assessmentDevelopmental Quotient (DQ) before surgery
LVEF one month after the surgeryone month after surgeryLeft ventricular ejection fraction one month after the surgery
rHRI one month after the surgery rHRI one month after the surgeryone month after surgeryThe rate of increase in heart rate one month after the surgery
rHRR one month after the surgeryone month after surgeryThe rate of recovery heart rate one month after the surgery
Alberta score one month after the surgeryone month after surgeryAlberta motor test results one month after the surgery
Neuro-intelligence Scale one month after the surgeryone month after surgeryDevelopmental Quotient (DQ) one month after the surgery
LVEF three months after the surgerythree months after surgeryLeft ventricular ejection fraction three months after the surgery
rHRI three months after the surgerythree months after surgeryThe rate of increase in heart rate three months after the surgery
rHRR three months after the surgerythree months after surgeryThe rate of recovery heart rate three months after the surgery
Alberta score three months after the surgerythree months after surgeryAlberta motor test results three months after the surgery
Neuro-intelligence Scale three months after the surgerythree months after surgeryDevelopmental Quotient (DQ) three months after the surgery
LVEF six months after the surgerysix months after surgeryLeft ventricular ejection fraction six months after the surgery
rHRI six months after the surgerysix months after surgeryThe rate of increase in heart rate six months after the surgery
rHRR six months after the surgerysix months after surgeryThe rate of recovery heart rate six months after the surgery
Alberta score six months after the surgerysix months after surgeryAlberta motor test results six months after the surgery
Neuro-intelligence Scale six months after the surgerysix months after surgeryDevelopmental Quotient (DQ) six months after the surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026