Tetralogy of FallotNCT02643810
Exercise Training in Adults With Corrected Tetralogy of Fallot
A study testing Exercise training in people with Tetralogy of Fallot, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
In this controlled trial, patients with tetralogy of Fallot will be randomized to either interval training, continuous training, or usual care groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetralogy of Fallot
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSlovenia
- Study dates
- Jun 2015to 5 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- congenital tetralogy of Fallot surgically corrected in childhood
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Adult Individuals With Corrected Tetralogy of Fallot
In this controlled trial, patients with tetralogy of Fallot will be randomized to either interval training, continuous training, or usual care groups.
Read the 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:
- 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
- Conditions
- Tetralogy of Fallot
- Being tested
- Exercise training
- Keywords
- exercise training
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Exercise training |
| Usual care group | No intervention | Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of maximal oxygen uptake during exercise, measured in ml/kg/min
Measured: 3 months
Secondary outcomes (9)
Change of flow-mediated dilatation of the brachial artery, measured in %
Flow-mediated dilation (FMD) and arterial stiffness
Measured: 3 months
Change of the arterial stiffness coefficient
Measured: 3 months
Change of the value of blood N terminal-proBNP, measured in ng/l
Measured: 3 months
Change of the value of blood D-dimer, measured in microg/l
Measured: 3 months
Change of the value of blood fibrinogen, measured in g/l
Measured: 3 months
Change of from-the-questionnaire-obtained quality of life, measured in points
Measured: 3 months
Change of the ECG waves
Estimated with digital high-resolution ECG
Measured: 3 months
Change of the heart rate variability
Estimated with digital high-resolution ECG
Measured: 3 months
Change in the result of the 6-minute walking test, measured in metres
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJun 2015
- Primary completion5 Mar 2017
- Study completion5 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borut Jug, University Medical Centre Ljubljana
- Investigators
- Borut Jug, MD, Ph.D., Principal investigator, University Medical Centre Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643810
- Sponsor's protocol ID
- UKCLRehab0012015
- Status last verified
- Mar 2017
- First submitted
- 20 Dec 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
Publications
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.
PubMed 23787793Hirth 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.
PubMed 16926656Dua 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.
PubMed 19217676Duppen 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.
PubMed 25464424Duppen 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.
PubMed 23746621Novakovic 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.
PubMed 29338917
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Adult Individuals With Corrected Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT02643810
- Acronym / sponsor ID
- UKCLRehab0012015
- Conditions
- Tetralogy of Fallot
- Keywords
- exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 5 Mar 2017 (actual)
- Study completion
- 5 Mar 2017 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interval training group | Active comparator | Other: Exercise trainingPatients 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 | Other: Exercise trainingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- congenital tetralogy of Fallot surgically corrected in childhood
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingPatients 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. | Other | Continuous training group, Interval training group |
Primary outcome
Change of maximal oxygen uptake during exercise, measured in ml/kg/min
Time frame: 3 months
9 secondary outcomes
Change of flow-mediated dilatation of the brachial artery, measured in %
Time frame: 3 months
Change of the arterial stiffness coefficient
Time frame: 3 months
Change of the value of blood N terminal-proBNP, measured in ng/l
Time frame: 3 months
Change of the value of blood D-dimer, measured in microg/l
Time frame: 3 months
Change of the value of blood fibrinogen, measured in g/l
Time frame: 3 months
Change of from-the-questionnaire-obtained quality of life, measured in points
Time frame: 3 months
Change of the ECG waves
Time frame: 3 months
Change of the heart rate variability
Time frame: 3 months
Change in the result of the 6-minute walking test, measured in metres
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Background: PubMed 23787793Dulfer 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.
- Background: PubMed 16926656Hirth 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.
- Background: PubMed 19217676Dua 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.
- Background: PubMed 25464424Duppen 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.
- Background: PubMed 23746621Duppen 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.
- Derived from this study: PubMed 29338917Novakovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borut Jug, MD, Ph.D. principal investigator
University Medical Centre Ljubljana, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Tetralogy of Fallot, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of maximal oxygen uptake during exercise, measured in ml/kg/min (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02643810, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.