Exercise Training in Adults With Corrected Tetralogy of Fallot

Not Applicable

Completed

• Conditions: Tetralogy of Fallot
• Interventions: Other: Exercise training

• Registration Number: NCT02643810
• Lead Sponsor: University Medical Centre Ljubljana

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-12-20
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2015-12-31
• Status Verified: 2017-03
• Primary Completion: 2017-03-05
• Study Completion: 2017-03-05
• Last Update Submitted: 2017-03-05
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interval training group	Exercise training	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).
Continuous training group	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.

Primary Outcome Measures

Name	Time	Method
Change of maximal oxygen uptake during exercise, measured in ml/kg/min	3 months

Secondary Outcome Measures

Name	Time	Method
Change of the value of blood fibrinogen, measured in g/l	3 months
Change of the ECG waves	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 flow-mediated dilatation of the brachial artery, measured in %	3 months	Flow-mediated dilation (FMD) and arterial stiffness
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	Estimated with digital high-resolution ECG
Change of the arterial stiffness coefficient	3 months

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia