Tetralogy of Fallot
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
12 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, the subject with rToF participated in the TOFFIE-1 study. Inclusion criteria for the TOFFIE-1 study (METc 2015/254) were: 1. Children and adolescents with corrected rToF aged 8-18 years, followed routinely in the UMCG. 2. Height >120 cm in order to fit the bicycle used during the exercise testing. 3. Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria for the TOFFIE-1 study were: 1. Patients with mental retardation 2. Patients who have contra indications for exercise testing 3. Patients known with muscular dystrophy 4. Patients with instable lung disease 5. Patients with previous surgery for scoliosis 6. Pregnant patients A potential subject who, since inclusion in TOFFIE-1 study, meets any of the original TOFFIE-1 exclusion criteria will be excluded from participation in the TOFFIE-2 study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters are VO2peak measured by cardiopulmonary exercise testing (CPET) and daily physical activity measured by accelerometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are cardiac function, pulmonary function, muscle strength, cardiac serum biomarker NT-pro-BNP, quality of life, sports participation, cardiac related anxiety and parental overprotectiveness. | — |
Countries
Netherlands
Outcome results
None listed