Clinical trial NCT05518136: Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease
Official title: APP Rehabilitation Management and Evaluations of Cardiopulmonary Function and Motor Development in Infants With Congenital Heart Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease in Children
Infant Development
Infant Conditions
Motor Neuropathy
Motor Delay
Cardiopulmonary
Keywords: infant
rehab management APP
home-based exercise
cardiopulmonary endurance
motor developmental level
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Baseline LVEF
timeFrame: pre-operative for baseline assessment
measure: Baseline rHRI
timeFrame: pre-operative for baseline assessment
measure: Baseline rHRR
timeFrame: pre-operative for baseline assessment
measure: Baseline Alberta score
timeFrame: pre-operative for baseline assessment
measure: Baseline Neuro-intelligence Scale
timeFrame: pre-operative for baseline assessment
measure: LVEF one month after the surgery
timeFrame: one month after surgery
measure: rHRI one month after the surgery rHRI one month after the surgery
timeFrame: one month after surgery
measure: rHRR one month after the surgery
timeFrame: one month after surgery
measure: Alberta score one month after the surgery
timeFrame: one month after surgery
measure: Neuro-intelligence Scale one month after the surgery
timeFrame: one month after surgery
measure: LVEF three months after the surgery
timeFrame: three months after surgery
measure: rHRI three months after the surgery
timeFrame: three months after surgery
measure: rHRR three months after the surgery
timeFrame: three months after surgery
measure: Alberta score three months after the surgery
timeFrame: three months after surgery
measure: Neuro-intelligence Scale three months after the surgery
timeFrame: three months after surgery
measure: LVEF six months after the surgery
timeFrame: six months after surgery
measure: rHRI six months after the surgery
timeFrame: six months after surgery
measure: rHRR six months after the surgery
timeFrame: six months after surgery
measure: Alberta score six months after the surgery
timeFrame: six months after surgery
measure: Neuro-intelligence Scale six months after the surgery
timeFrame: six months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital
state: Beijing
Study officials:
affiliation: Beijing Children's Hospital
name: Gejingwa Zhao
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gurvitz M, Valente AM, Broberg C, Cook S, Stout K, Kay J, Ting J, Kuehl K, Earing M, Webb G, Houser L, Opotowsky A, Harmon A, Graham D, Khairy P, Gianola A, Verstappen A, Landzberg M; Alliance for Adult Research in Congenital Cardiology (AARCC) and Adult Congenital Heart Association. Prevalence and predictors of gaps in care among adult congenital heart disease patients: HEART-ACHD (The Health, Education, and Access Research Trial). J Am Coll Cardiol. 2013 May 28;61(21):2180-4. doi: 10.1016/j.jacc.2013.02.048. Epub 2013 Mar 28.