Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)

Study Overview
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Brief Summary
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Children with congenital heart defects have shown to develop motor coordinative deficiencies. In this study we want to show that a motor pedagogic physical training can improve the coordinative capabilities of children aged 4-6 years.

Detailed Description
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The study will be performed with a randomized crossover design. After the first assessment of coordinative capabilities children were randomized into two groups. One starts with exercised training for three months. After midterm assessment of the capabilities they will pause for another 3 months and reassessed. The second group will start without training for the first three months. After midterm assessment they will train for three months and have their final assessment.

Official Title
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Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)

Conditions
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Heart Defects, Congenital

Intervention / Treatment
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* Behavioral: Motorpedagogic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: without significant residuals hemodynamically not significant without significant residuals after repair age 4-6 incl. Exclusion Criteria: gradient at coarctation site > 20 mmHg gradient RVOT, PV, LVOT, or AoV > 30 mmHg right-left shunt (rest or exercise) left-right shunt with dilatation or failure of ana cardiac chamber pulmonary hypertension heart failure, necessitating therapy (suspected) myocarditis or cardiomyopathy significant arrhythmia ion channel defects, other arrhythmic diseases Fontan-like circulation repair by atrial switch oral anticoagulation other medical problems curtailing exercise capacity

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>physical training | Behavioral: Motorpedagogic exercise<br>* physical training<br>|
| No Intervention: 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity: triaxial accelerometry |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coordinative test: MOT 4-6 |  | 3 months | 
| coordinative test: LOS KF 18 |  | 3 months | 
| Quality of life: Kiddy-KINDL |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital heart disease, exercise training, motorpedagogical exercise, children, CHD: hemodynamically not significant defects, CHD: acyanotic defects after repair, CHD: cyanotic defects after repair