Exercise Training in Congenital Heart Disease.

A multi-centered study in the Netherlands to the effect of an exercise training program in children and adolescents (aged 12-20) who have undergone treatment for congenital heart disease (Tetralogy of Fallot and Fontan procedure) on:

1. Aerobic fitness;

2. Cardiac functioning;

3. Daily physical activity;

4. Health related quality of life.

The study has a prospective, randomized, controlled, interventional design.

We hypothesize that exercise training will:

1. Improve aerobic fitness;

2. Will not result in adverse remodeling and/or decline of ejection fraction;

3. Will increase daily activity levels;

4. Will improve health related quality of life and psychosocial functioning.

Exercise group:

1. Baseline measurements: Within 2 months of the start of the exercise program (T0);

2. Repeated measurements: Within 2 weeks after the completion of the exercise program (T1).



Control group:

Approximately 3 months between baseline measurements and repeated measurements.



Measurements:

1. Aerobic fitness (oxygen uptake and peak power in last half minute of graded bicycle ergometer test);

2. Cardiac functioning (end-systolic and end-diastolic volume of RV and LV (Fallot group) or single ventricle (Fontan group), ejection fraction, functional reserve, NT-proBNP level);

3. Daily physical activity (percentage of day during which dynamic activities have been performed, average motility, assessed by means of an Activity Monitor);

4. Health related quality of life (assessed by TACQOL 12-15 CF and PF, SF-36 and TAAQOL-CHD);

5. Psychosocial functioning (assessed by YSR, ASR, CBCL and ABCL; STAIC, STAI-DY; SPP-A, GSES-12).

The patients randomized to the exercise program will perform exercise training. The exercise training program will consist of 3 training sessions of 1 hour per week, for a 3-month period. Training will be aerobic at 60-70% (instead of 60%) of heart rate reserve. Standardized training will be performed group-wise under supervision of a physiotherapist at local fitness-centers. The patients randomized to the control group will continu their daily activities.

A multi-centered study in the Netherlands to the effect of an exercise training program in children and adolescents aged 10-25 instead of aged 12-20.