Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Adult Individuals With Corrected Tetralogy of Fallot
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Change of maximal oxygen uptake during exercise, measured in ml/kg/min
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Interval training group
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).
Intervention: Exercise training (Other)
Continuous training group
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.
Intervention: Exercise training (Other)
Usual care group
Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks.
Outcomes
Primary Outcomes
Change of maximal oxygen uptake during exercise, measured in ml/kg/min
Time Frame: 3 months
Secondary Outcomes
- Change of the value of blood fibrinogen, measured in g/l(3 months)
- Change of the ECG waves(3 months)
- Change in the result of the 6-minute walking test, measured in metres(3 months)
- Change of flow-mediated dilatation of the brachial artery, measured in %(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 heart rate variability(3 months)
- Change of the arterial stiffness coefficient(3 months)
Investigators
Borut Jug
Assistant Professor
University Medical Centre Ljubljana