Exercise Training in Adults With Corrected Tetralogy of Fallot

NCT02643810 | Completed

• 1 other identifier: UKCLRehab0012015
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tetralogy of Fallot

Keywords

exercise training

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (9)

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

  3 months

• Change of the arterial stiffness coefficient

  3 months

• 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

Other Outcomes (1)

• Change of the heart rate recovery

  3 months

Study Arms (3)

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).

Other: Exercise training

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.

Other: Exercise training

Usual care group

NO INTERVENTION

Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks.

Interventions

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.

Continuous training group; Interval training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• congenital tetralogy of Fallot surgically corrected in childhood

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Related Publications (6)

• 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.

  PMID: 23787793 BACKGROUND

• 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.

  PMID: 16926656 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.

  PMID: 19217676 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.

  PMID: 25464424 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.

  PMID: 23746621 BACKGROUND

• 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.

  PMID: 29338917 DERIVED

MeSH Terms

Conditions

Tetralogy of Fallot

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Borut Jug, MD, Ph.D.

  University Medical Centre Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2015
• First Posted: December 31, 2015
• Study Start: June 1, 2015
• Primary Completion: March 5, 2017
• Study Completion: March 5, 2017
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

SL (1)