Back to resultsEvaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease
Primary Purpose
Congenital Heart Disease in Children, Infant Development, Infant Conditions
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
exercise-guidance on rehab APP
Sponsored by
About this trial
This is an interventional supportive care trial for Congenital Heart Disease in Children focused on measuring infant, rehab management APP, home-based exercise, cardiopulmonary endurance, motor developmental level
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
Sites / Locations
- Beijing Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Recovery group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Baseline LVEF
Left ventricular ejection fraction before surgery
Baseline rHRI
The rate of increase in heart rate before surgery
Baseline rHRR
The rate of recovery heart rate before surgery
Baseline Alberta score
Alberta motor test results before surgery
Baseline Neuro-intelligence Scale
Developmental Quotient (DQ) before surgery
LVEF one month after the surgery
Left ventricular ejection fraction one month after the 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
rHRR one month after the surgery
The rate of recovery heart rate one month after the surgery
Alberta score one month after the surgery
Alberta motor test results one month after the surgery
Neuro-intelligence Scale one month after the surgery
Developmental Quotient (DQ) one month after the surgery
LVEF three months after the surgery
Left ventricular ejection fraction three months after the surgery
rHRI three months after the surgery
The rate of increase in heart rate three months after the surgery
rHRR three months after the surgery
The rate of recovery heart rate three months after the surgery
Alberta score three months after the surgery
Alberta motor test results three months after the surgery
Neuro-intelligence Scale three months after the surgery
Developmental Quotient (DQ) three months after the surgery
LVEF six months after the surgery
Left ventricular ejection fraction six months after the surgery
rHRI six months after the surgery
The rate of increase in heart rate six months after the surgery
rHRR six months after the surgery
The rate of recovery heart rate six months after the surgery
Alberta score six months after the surgery
Alberta motor test results six months after the surgery
Neuro-intelligence Scale six months after the surgery
Developmental Quotient (DQ) six months after the surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05518136
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
May 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gejingwa Zhao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recovery group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
exercise-guidance on rehab APP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline LVEF
Description
Left ventricular ejection fraction before surgery
Time Frame
pre-operative for baseline assessment
Title
Baseline rHRI
Description
The rate of increase in heart rate before surgery
Time Frame
pre-operative for baseline assessment
Title
Baseline rHRR
Description
The rate of recovery heart rate before surgery
Time Frame
pre-operative for baseline assessment
Title
Baseline Alberta score
Description
Alberta motor test results before surgery
Time Frame
pre-operative for baseline assessment
Title
Baseline Neuro-intelligence Scale
Description
Developmental Quotient (DQ) before surgery
Time Frame
pre-operative for baseline assessment
Title
LVEF one month after the surgery
Description
Left ventricular ejection fraction one month after the surgery
Time Frame
one month after surgery
Title
rHRI one month after the surgery rHRI one month after the surgery
Description
The rate of increase in heart rate one month after the surgery
Time Frame
one month after surgery
Title
rHRR one month after the surgery
Description
The rate of recovery heart rate one month after the surgery
Time Frame
one month after surgery
Title
Alberta score one month after the surgery
Description
Alberta motor test results one month after the surgery
Time Frame
one month after surgery
Title
Neuro-intelligence Scale one month after the surgery
Description
Developmental Quotient (DQ) one month after the surgery
Time Frame
one month after surgery
Title
LVEF three months after the surgery
Description
Left ventricular ejection fraction three months after the surgery
Time Frame
three months after surgery
Title
rHRI three months after the surgery
Description
The rate of increase in heart rate three months after the surgery
Time Frame
three months after surgery
Title
rHRR three months after the surgery
Description
The rate of recovery heart rate three months after the surgery
Time Frame
three months after surgery
Title
Alberta score three months after the surgery
Description
Alberta motor test results three months after the surgery
Time Frame
three months after surgery
Title
Neuro-intelligence Scale three months after the surgery
Description
Developmental Quotient (DQ) three months after the surgery
Time Frame
three months after surgery
Title
LVEF six months after the surgery
Description
Left ventricular ejection fraction six months after the surgery
Time Frame
six months after surgery
Title
rHRI six months after the surgery
Description
The rate of increase in heart rate six months after the surgery
Time Frame
six months after surgery
Title
rHRR six months after the surgery
Description
The rate of recovery heart rate six months after the surgery
Time Frame
six months after surgery
Title
Alberta score six months after the surgery
Description
Alberta motor test results six months after the surgery
Time Frame
six months after surgery
Title
Neuro-intelligence Scale six months after the surgery
Description
Developmental Quotient (DQ) six months after the surgery
Time Frame
six months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gejingwa Zhao
Organizational Affiliation
Beijing Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Children's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23542112
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.
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Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease
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