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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gejingwa Zhao | Beijing Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23542112 | Background | 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 13, 2022 | Aug 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009443 | Neuritis |
| D011596 | Psychomotor Disorders |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D019954 | Neurobehavioral Manifestations |
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| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |