Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease

NCT ID: NCT05518136

Last Updated: 2022-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-10

Study Completion Date

2022-05-25

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease in Children Infant Development Infant Conditions Motor Neuropathy Motor Delay Cardiopulmonary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

exercise-guidance on rehab APP

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

4 Months

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gejingwa Zhao

OTHER

Sponsor Role lead

Responsible Party

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Gejingwa Zhao

Doctor, Doctor of Cardiac Surgery Department, Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gejingwa Zhao

Role: PRINCIPAL_INVESTIGATOR

Beijing Children's Hospital

Locations

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Beijing Children's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 23542112 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Beijing Children's Hospital

Identifier Type: -

Identifier Source: org_study_id

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