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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interval training group | Active Comparator | 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 | Active Comparator | 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. |
|
| Usual care group | No Intervention | Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of maximal oxygen uptake during exercise, measured in ml/kg/min | 3 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the heart rate recovery | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Borut Jug, MD, Ph.D. | University Medical Centre Ljubljana, Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana | Ljubljana | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23787793 | Background | 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. | |
| 16926656 | Background |
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| ID | Term |
|---|---|
| D013771 | Tetralogy of Fallot |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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 |
| 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. |
| 19217676 | Background | 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. |
| 25464424 | Background | 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. |
| 23746621 | Background | 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. |
| 29338917 | Derived | 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. |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |