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

German Heart Center Munich

Status: Unknown

Conditions: Heart Defects, Congenital

Treatments: Behavioral: Motorpedagogic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00436098

GE IDE No. H00107

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Experimental group

Description:

physical training

Treatment:

Behavioral: Motorpedagogic exercise

2

No Intervention group