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

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.

Study Overview

• Status: Completed
• Conditions: Infant Conditions; Infant Development; Congenital Heart Disease in Children; Motor Delay; Motor Neuropathy; Cardiopulmonary
• Intervention / Treatment: Behavioral: exercise-guidance on rehab APP

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recovery group; 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.	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.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gejingwa Zhao
• Investigators: Principal Investigator: Gejingwa Zhao, Beijing Children's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2021
• Primary Completion (Actual): December 28, 2021
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: infant; home-based exercise; rehab management APP; cardiopulmonary endurance; motor developmental level
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: Beijing Children's Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No