Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05518136
• Other study ID #: Beijing Children's Hospital
• Status: Completed
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: August 2022
• Source: Beijing Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 25, 2022
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 8 Months

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• exercise-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.

Locations

Country	Name	City	State
China	Beijing Children's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Gejingwa Zhao

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

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