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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00436098

Enrollment

Registered

2007-02-16

Start date

2007-02-28

Completion date

2010-05-31

Last updated

2008-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Defects, Congenital

Keywords

congenital heart disease, exercise training, motorpedagogical exercise, children, CHD: hemodynamically not significant defects, CHD: acyanotic defects after repair, CHD: cyanotic defects after repair

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.

Interventions

BEHAVIORALMotorpedagogic exercise

physical training

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 7 Years

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

Design outcomes

Primary

Measure	Time frame
Activity: triaxial accelerometry	3 months

Secondary

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

Countries

Germany

Contacts

Primary ContactAlfred Hager, MD

a-hager@web.de+49-89-1218

Backup ContactMilka Pringsheim, MD

pringsheim@dhm.mhn.de+49-89-1218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026