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

Not Applicable

• Conditions: Heart Defects, Congenital
• Interventions: Behavioral: Motorpedagogic exercise

• Registration Number: NCT00436098
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-15
• Study First Submitted QC: 2007-02-15
• Study First Posted: 2007-02-16
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-26
• Last Update Posted: 2008-08-27
• Primary Completion: 2009-11
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Motorpedagogic exercise	physical training

Primary Outcome Measures

Name	Time	Method
Activity: triaxial accelerometry	3 months

Secondary Outcome Measures

Name	Time	Method
coordinative test: MOT 4-6	3 months
coordinative test: LOS KF 18	3 months
Quality of life: Kiddy-KINDL	3 months

Trial Locations

Locations (2)

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany

Kuratorium für Prävention und Rehabilitation der TU München; 🇩🇪 Munich, Germany