Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease

NCT05518136 | Completed DMC

• 1 other identifier: Beijing Children's Hospital
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (20)

• 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

Study Arms (2)

Recovery group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

exercise-guidance on rehab APP BEHAVIORAL

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.

Recovery group

Eligibility Criteria

• Age: 4 Months - 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• CHD infants (aged 4-8 months) with atrial septum defect (ASD) or ventricular septum defect (VSD)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gejingwa Zhao: lead

Study Sites (1)

Beijing Children's Hospital

Beijing, Beijing Municipality, 100000, China

Location

Related 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.

  PMID: 23542112 BACKGROUND

MeSH Terms

Conditions

Neuritis; Psychomotor Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gejingwa Zhao

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor, Doctor of Cardiac Surgery Department, Principal Investigator

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 26, 2022
• Study Start: April 10, 2021
• Primary Completion: December 28, 2021
• Study Completion: May 25, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

CN (1)