Tetralogy of Fallot
Conditions
Keywords
exercise training
Brief summary
In this controlled trial, patients with tetralogy of Fallot will be randomized to either interval training, continuous training, or usual care groups.
Detailed description
Patients after surgical correction of tetralogy of Fallot (cTF) have impaired exercise tolerance as compared to healthy age-matched individuals. In this controlled trial, patients with cTF will be randomized to either interval training, continuous training, or usual care. The aim of the study is to compare the effect of interval vs. continuous exercise training on: i) exercise capacity ii) vascular function iii) arrhythmogenic potential iv) parameters of inflammation, hemostasis and heart failure severity v) health-related quality of life adults with cTF
Interventions
OTHERExercise training
Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions 3 times per week for a period of 12 weeks.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* congenital tetralogy of Fallot surgically corrected in childhood
Exclusion criteria
* contraindications for exercise training, * uncontrolled dysrhythmias, * uncontrolled heart failure (New York Heart Association (NYHA) stage IV), * unstable coronary or other arterial disease, * intellectual development disorder, * pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of maximal oxygen uptake during exercise, measured in ml/kg/min | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of flow-mediated dilatation of the brachial artery, measured in % | 3 months | Flow-mediated dilation (FMD) and arterial stiffness |
| Change of the arterial stiffness coefficient | 3 months | — |
| Change of the value of blood N terminal-proBNP, measured in ng/l | 3 months | — |
| Change of the value of blood D-dimer, measured in microg/l | 3 months | — |
| Change of from-the-questionnaire-obtained quality of life, measured in points | 3 months | — |
| Change of the ECG waves | 3 months | Estimated with digital high-resolution ECG |
| Change of the heart rate variability | 3 months | Estimated with digital high-resolution ECG |
| Change in the result of the 6-minute walking test, measured in metres | 3 months | — |
| Change of the value of blood fibrinogen, measured in g/l | 3 months | — |
Other
| Measure | Time frame |
|---|---|
| Change of the heart rate recovery | 3 months |
Countries
Slovenia
Outcome results
None listed