Exercise Training in Adults With Corrected Tetralogy of Fallot

Tetralogy of Fallot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643810
• Other study ID #: UKCLRehab0012015
• Status: Completed
• Phase: N/A
• First received: December 20, 2015
• Last updated: March 5, 2017
• Start date: June 2015
• Est. completion date: March 5, 2017

Study information

• Verified date: March 2017
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 5, 2017
• Est. primary completion date: March 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tetralogy of Fallot

Intervention

Other:
• Exercise training
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.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (5)

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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of the heart rate recovery		3 months
Primary	Change of maximal oxygen uptake during exercise, measured in ml/kg/min		3 months
Secondary	Change of flow-mediated dilatation of the brachial artery, measured in %	Flow-mediated dilation (FMD) and arterial stiffness	3 months
Secondary	Change of the arterial stiffness coefficient		3 months
Secondary	Change of the value of blood N terminal-proBNP, measured in ng/l		3 months
Secondary	Change of the value of blood D-dimer, measured in microg/l		3 months
Secondary	Change of the value of blood fibrinogen, measured in g/l		3 months
Secondary	Change of from-the-questionnaire-obtained quality of life, measured in points		3 months
Secondary	Change of the ECG waves	Estimated with digital high-resolution ECG	3 months
Secondary	Change of the heart rate variability	Estimated with digital high-resolution ECG	3 months
Secondary	Change in the result of the 6-minute walking test, measured in metres		3 months