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Exercise Training in Adults With Corrected Tetralogy of Fallot

Primary Purpose

Tetralogy of Fallot

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tetralogy of Fallot focused on measuring exercise training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Medical Centre Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Interval training group

Continuous training group

Usual care group

Arm Description

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).

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of flow-mediated dilatation of the brachial artery, measured in %
Flow-mediated dilation (FMD) and arterial stiffness
Change of the arterial stiffness coefficient
Change of the value of blood N terminal-proBNP, measured in ng/l
Change of the value of blood D-dimer, measured in microg/l
Change of the value of blood fibrinogen, measured in g/l
Change of from-the-questionnaire-obtained quality of life, measured in points
Change of the ECG waves
Estimated with digital high-resolution ECG
Change of the heart rate variability
Estimated with digital high-resolution ECG
Change in the result of the 6-minute walking test, measured in metres

Full Information

First Posted
December 20, 2015
Last Updated
March 5, 2017
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT02643810
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 5, 2017 (Actual)
Study Completion Date
March 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetralogy of Fallot
Keywords
exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interval training group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Continuous training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
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 Outcome Measure Information:
Title
Change of maximal oxygen uptake during exercise, measured in ml/kg/min
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change of flow-mediated dilatation of the brachial artery, measured in %
Description
Flow-mediated dilation (FMD) and arterial stiffness
Time Frame
3 months
Title
Change of the arterial stiffness coefficient
Time Frame
3 months
Title
Change of the value of blood N terminal-proBNP, measured in ng/l
Time Frame
3 months
Title
Change of the value of blood D-dimer, measured in microg/l
Time Frame
3 months
Title
Change of the value of blood fibrinogen, measured in g/l
Time Frame
3 months
Title
Change of from-the-questionnaire-obtained quality of life, measured in points
Time Frame
3 months
Title
Change of the ECG waves
Description
Estimated with digital high-resolution ECG
Time Frame
3 months
Title
Change of the heart rate variability
Description
Estimated with digital high-resolution ECG
Time Frame
3 months
Title
Change in the result of the 6-minute walking test, measured in metres
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Change of the heart rate recovery
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borut Jug, MD, Ph.D.
Organizational Affiliation
University Medical Centre Ljubljana, Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23787793
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.
Results Reference
background
PubMed Identifier
16926656
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.
Results Reference
background
PubMed Identifier
19217676
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.
Results Reference
background
PubMed Identifier
25464424
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.
Results Reference
background
PubMed Identifier
23746621
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.
Results Reference
background
PubMed Identifier
29338917
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.
Results Reference
derived

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Exercise Training in Adults With Corrected Tetralogy of Fallot

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