Exercise Training in Adults With Corrected Tetralogy of Fallot

University Medical Centre Ljubljana27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tetralogy of Fallot

Interventions

Exercise trainingOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Medical Centre Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

Change of maximal oxygen uptake during exercise, measured in ml/kg/min

Time frame: 3 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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