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Completed

NCT Number: NCT02643810

Exercise Training in Adults With Corrected Tetralogy of Fallot

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

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Key information

Conditions

Tetralogy of Fallot Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, Slovenia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise training

Other

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.

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. Change of flow-mediated dilatation of the brachial artery, measured in %

    Time frame: 3 months

    Flow-mediated dilation (FMD) and arterial stiffness

  2. Change of the arterial stiffness coefficient

    Time frame: 3 months

  3. Change of the value of blood N terminal-proBNP, measured in ng/l

    Time frame: 3 months

  4. Change of the value of blood D-dimer, measured in microg/l

    Time frame: 3 months

  5. Change of the value of blood fibrinogen, measured in g/l

    Time frame: 3 months

  6. Change of from-the-questionnaire-obtained quality of life, measured in points

    Time frame: 3 months

  7. Change of the ECG waves

    Time frame: 3 months

    Estimated with digital high-resolution ECG

  8. Change of the heart rate variability

    Time frame: 3 months

    Estimated with digital high-resolution ECG

  9. Change in the result of the 6-minute walking test, measured in metres

    Time frame: 3 months

Other outcomes

  1. Change of the heart rate recovery

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 31, 2015
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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