Clinical trial NCT02643810: Exercise Training in Adults With Corrected Tetralogy of Fallot
Official title: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Adult Individuals With Corrected Tetralogy of Fallot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tetralogy of Fallot
Keywords: exercise training
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change of maximal oxygen uptake during exercise, measured in ml/kg/min
timeFrame: 3 months
Secondary outcomes:
measure: Change of flow-mediated dilatation of the brachial artery, measured in %
timeFrame: 3 months
measure: Change of the arterial stiffness coefficient
timeFrame: 3 months
measure: Change of the value of blood N terminal-proBNP, measured in ng/l
timeFrame: 3 months
measure: Change of the value of blood D-dimer, measured in microg/l
timeFrame: 3 months
measure: Change of the value of blood fibrinogen, measured in g/l
timeFrame: 3 months
measure: Change of from-the-questionnaire-obtained quality of life, measured in points
timeFrame: 3 months
measure: Change of the ECG waves
timeFrame: 3 months
measure: Change of the heart rate variability
timeFrame: 3 months
measure: Change in the result of the 6-minute walking test, measured in metres
timeFrame: 3 months
Other outcomes:
measure: Change of the heart rate recovery
timeFrame: 3 months
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana, Slovenia
name: Borut Jug, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dulfer K, Helbing WA, Duppen N, Utens EM. Associations between exercise capacity, physical activity, and psychosocial functioning in children with congenital heart disease: a systematic review. Eur J Prev Cardiol. 2014 Oct;21(10):1200-15. doi: 10.1177/2047487313494030. Epub 2013 Jun 20.
citation: Hirth A, Reybrouck T, Bjarnason-Wehrens B, Lawrenz W, Hoffmann A. Recommendations for participation in competitive and leisure sports in patients with congenital heart disease: a consensus document. Eur J Cardiovasc Prev Rehabil. 2006 Jun;13(3):293-9. doi: 10.1097/01.hjr.0000220574.22195.d6.
citation: Dua JS, Cooper AR, Fox KR, Graham Stuart A. Exercise training in adults with congenital heart disease: feasibility and benefits. Int J Cardiol. 2010 Jan 21;138(2):196-205. doi: 10.1016/j.ijcard.2009.01.038. Epub 2009 Feb 13.
citation: Duppen N, Kapusta L, de Rijke YB, Snoeren M, Kuipers IM, Koopman LP, Blank AC, Blom NA, Dulfer K, Utens EM, Hopman MT, Helbing WA. The effect of exercise training on cardiac remodelling in children and young adults with corrected tetralogy of Fallot or Fontan circulation: a randomized controlled trial. Int J Cardiol. 2015 Jan 20;179:97-104. doi: 10.1016/j.ijcard.2014.10.031. Epub 2014 Oct 22.
citation: Duppen N, Takken T, Hopman MT, ten Harkel AD, Dulfer K, Utens EM, Helbing WA. Systematic review of the effects of physical exercise training programmes in children and young adults with congenital heart disease. Int J Cardiol. 2013 Oct 3;168(3):1779-87. doi: 10.1016/j.ijcard.2013.05.086. Epub 2013 Jun 6.
citation: Novakovic M, Prokselj K, Rajkovic U, Vizintin Cuderman T, Jansa Trontelj K, Fras Z, Jug B. Exercise training in adults with repaired tetralogy of Fallot: A randomized controlled pilot study of continuous versus interval training. Int J Cardiol. 2018 Mar 15;255:37-44. doi: 10.1016/j.ijcard.2017.12.105. Epub 2018 Jan 3.