Evolution over time of exercise capacity in Tetralogy of Fallot, a follow up study of *TOFFIE* study participants
- Conditions
- Tetralogy of Fallot10010394
- Registration Number
- NL-OMON53286
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 71
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 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameters are VO2peak measured by cardiopulmonary exercise<br /><br>testing (CPET) and daily physical activity measured by accelerometry.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters are cardiac function, pulmonary function, muscle<br />strength, cardiac serum biomarker NT-pro-BNP, quality of life, sports<br />participation, cardiac related anxiety and parental overprotectiveness.</p>