Exercise capacity in Tetralogy of Fallot: heart, lungs or muscles?

Completed

Conditions: congenital heart defect
Tetralogy of Fallot
10010394
10007510

Registration Number: NL-OMON42647

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

1) Children and adolescents corrected for Tetralogy of Fallot, 21 years old or younger (minimum age of 8) followed routinely in the University Medical Centre Groningen.
2) Children and adolescents with a corrected Coarctatio aortae, 21 years old or younger (minimum age of 8) followed routinely in the University Medical Centre Groningen.
3) Height > 120 cm in order to be able to fit on the bicycle.
4) Written informed consent.

Exclusion Criteria

For all participants
- Patients with mental retardation.
- Patients who have contra-indications for exercise testing.
- Patients known with a muscular dystrophy (such as Becker or Duchenne).
- Patients with instable lung disease.
- Patients with previous surgery for scoliosis.
- Pregnant patients;For patients with coarctatio aortae
- Patients with more than one surgical intervention.
- Patients known to suffer from a hemodynamic significant re-coarctation (definition: pressure differences between ascending and descending aorta > 20 mmHg).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main endpoint: Cardiopulmonary exercise testing (peak VO2).<br /><br><br /><br>Main study parameters:<br /><br>1. Cardiac function (EF on MRI)<br /><br>2. Pulmonary function (FVC)<br /><br>3. Muscle strength (BOT-2)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. CPET variables: peak workload, peak Ve, Ve/VCO2 slope, O2-pulse, heart rate<br /><br>response to exercise (28).<br /><br>2. Cardiac assessment: residual lesions on echo (valve insufficiency and/or<br /><br>stenosis) graded according to Hamer and Pieper. Ventricular morphology and<br /><br>volumes on MRI (29)<br /><br>3. Pulmonary function: total lung capacity (TLC), force expiratory volume in 1<br /><br>second (FEV1), maximal inspiratory/expiratory pressures (MIP/MEP), residual<br /><br>volume (16,17).<br /><br>4. Muscle strength: handgrip strength, isotonic muscle strength (hand-held<br /><br>dynamometer of quadriceps, triceps and biceps).<br /><br>5. Quality of life assessed with PedsQL.<br /><br>6. Physical activity measured with accelerometer.</p><br>