Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease
NCT ID: NCT05518136
Last Updated: 2022-08-26
Study Results
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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COMPLETED
NA
28 participants
INTERVENTIONAL
2021-04-10
2022-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Months
8 Months
ALL
No
Sponsors
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Gejingwa Zhao
OTHER
Responsible Party
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Gejingwa Zhao
Doctor, Doctor of Cardiac Surgery Department, Principal 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
Countries
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Beijing Children's Hospital
Identifier Type: -
Identifier Source: org_study_id
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