Exercise Training in Adults With Corrected Tetralogy of Fallot

Study Overview
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Brief Summary
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In this controlled trial, patients with tetralogy of Fallot will be randomized to either interval training, continuous training, or usual care groups.

Detailed Description
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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

Official Title
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Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Adult Individuals With Corrected Tetralogy of Fallot

Conditions
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Tetralogy of Fallot

Intervention / Treatment
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* Other: Exercise training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interval training group<br>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<br>* 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.<br>|
| Active Comparator: Continuous training group<br>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<br>* 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.<br>|
| No Intervention: Usual care group<br>Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of maximal oxygen uptake during exercise, measured in ml/kg/min |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of flow-mediated dilatation of the brachial artery, measured in % | Flow-mediated dilation (FMD) and arterial stiffness | 3 months | 
| 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 the value of blood fibrinogen, measured in g/l |  | 3 months | 
| Change of from-the-questionnaire-obtained quality of life, measured in points |  | 3 months | 
| Change of the ECG waves | Estimated with digital high-resolution ECG | 3 months | 
| Change of the heart rate variability | Estimated with digital high-resolution ECG | 3 months | 
| Change in the result of the 6-minute walking test, measured in metres |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise training