An interventional study of Exercise training in Tetralogy of Fallot, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-07.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Treatment
In this controlled trial, patients with tetralogy of Fallot will be randomized to either interval training, continuous training, or usual care groups.
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
93 studies on the registry are indexed under Tetralogy of Fallot; 26 are open to participants now.
This study's enrollment of 27 is below the median of 51 across 52 interventional studies indexed under Tetralogy of Fallot.
Browse Tetralogy of Fallot studies →University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients to be randomized to the 'interval training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo interval exercise series composed of high-intensity intervals (80-90% of peak heart rate) and low-intensity intervals (50-70% of peak heart rate).
Other: Exercise training
Patients to be randomized to the 'continuous training group' will have exercise training sessions 3 times per week for a period of 12 weeks. They will undergo moderate continuous exercise training at 70-75% of peak heart rate.
Other: Exercise training
Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks.
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.
Change of maximal oxygen uptake during exercise, measured in ml/kg/min
Time frame: 3 months
Change of flow-mediated dilatation of the brachial artery, measured in %
Flow-mediated dilation (FMD) and arterial stiffness
Time frame: 3 months
Change of the arterial stiffness coefficient
Time frame: 3 months
Change of the value of blood N terminal-proBNP, measured in ng/l
Time frame: 3 months
Change of the value of blood D-dimer, measured in microg/l
Time frame: 3 months
Change of the value of blood fibrinogen, measured in g/l
Time frame: 3 months
Change of from-the-questionnaire-obtained quality of life, measured in points
Time frame: 3 months
Change of the ECG waves
Estimated with digital high-resolution ECG
Time frame: 3 months
Change of the heart rate variability
Estimated with digital high-resolution ECG
Time frame: 3 months
Change in the result of the 6-minute walking test, measured in metres
Time frame: 3 months
Change of the heart rate recovery
Time frame: 3 months
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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University Medical Centre Ljubljana