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ID
Source
Brief title
Health condition
Tetralogy of Fallot
Sponsors and support
Intervention
Outcome measures
Primary outcome
Decrease in pulse wave velocity in the aorta and pulmonary artery measured by
MRI.
Secondary outcome
Exercise capacity measured with a cardiopulmonary exercise test (VO2 peak
and Wattage peak)
2. Other measures of cardiac function:
* MRI: Left and right end diastolic, end systolic, stroke volume and ejection
fraction. Changes in wave reflection patterns in the pulmonary artery
following the method described by Schafer et al.(11) Mass and thickness
of the ventricle wall. Flow variables in the aorta and pulmonary arteries
not covered by our main endpoint including 4D flow analysis.
Patient data can be compared to existing local reference data of healthy
volunteers
* Echo: Two-dimensional echocardiography An echocardiogram will be
made by a trained sonographer or pediatric cardiologist on a
commercially available ultrasound platform. Echocardiography will be
used to assess the following variables of cardiac size and function:
Global ventricular function (ventricular volumes, ejection fraction)
Regional ventricular function: right and/or left ventricular or single
ventricular global and regional strain / strain rate. Diastolic ventricular
function: peak velocity of the antegrade systolic wave, early diastolic wave
and the peak velocity of the late diastolic retrograde wave will be
measured of the pulmonary venous flow E and A velocities, and E - A ratio
will be assessed of systemic atrioventricular flows. Semiquantitative
assessment of semilunar and atrioventricular valve regurgitation. Patient
data can be compared to existing local reference data of healthy
volunteers.
3. Changes in height, weight and body fat percentage and their derivates BMI and
BSA
4. Questionnaires of quality of life (QoL)
* Will be assed using CHQ-PF28, CHQ-CF45 (for participants under
18), SF36 (for participants over 18) and SQUASH
Background summary
Rationale: Tetralogy of Fallot is the most common type of cyanotic congenital heart disease.
The main problems of this patient population are heart failure related to chronic pulmonary
regurgitation, arrhythmias and sudden cardiac death. A major gap in our knowledge is how
coupling between the RV and pulmonary artery affects outcomes. A promising method to
investigate RV-PA coupling is by looking at pulse wave velocity and wave reflection patterns
in the main pulmonary artery and proximal branches non-invasively. It has been shown that
left sided pulse wave velocity can be improved by exercise training in Tetralogy of Fallot by
exercise training.
Objective: Primary Objective: To examine the effect of an online based exercise training
protocol on ventriculo-arterial coupling , as assessed by pulse wave velocity in the aorta and
pulmonary artery in patients operated for Tetralogy of Fallot.
Secondary Objective(s): To examine the effect of an online based exercise training protocol
on the increase in exercise capacity and quality of life in patients with Tetralogy of Fallot.
Study design: The design of our study is a cross-over interventional study. All children and
young adults will be randomized in 2 groups. One group will start with care/exercise as usual,
the other group will start with an online exercise training. After 12 weeks the groups will
change from protocol. Before start of measurements, after 12 weeks and group 2 after 24
weeks, all participants will undergo a number of tests, including echocardiogram,
cardiopulmonary exercise test, and cardiac magnetic resonance imaging.
Study population: 12-30 years of age, after surgical repair of tetralogy of Fallot (TOF), being
followed at one of the 2 locations of the Academic Center for Congenital Heart disease
(ACAHA) (Erasmus MC, Sophia children’s hospital, Radboud UMC Amalia children’s
hospital).
Intervention (if applicable): 12 weeks of online based interval training 3 times a week.
Main study parameters/endpoints: Decrease in pulse wave velocity in the aorta and
pulmonary artery measured by MRI.
Study objective
HIIT can lower PWV in the Aorta and pulmonary Artery in patients with Tetralogy of Fallot
Study design
Group A
Baseline (week 0)
After excercise program (week 12)
Group B
Baseline (week 0)
After control period (week 12)
After excercise program (week 24)
Intervention
Trainings intervention:
Due to the ongoing COVID-19 pandemic we prefer an online intervention (example
shown at: https://pedcardio.shinyapps.io/TOFHIIT-example/), in this pandemic it is not
clear if/when gyms and physiotherapists will be available.One training a week
consists of jump roping (training 1), one training are body weight exercises (training 2)
and the last training is one of the choosing of the participants such as running or bike
riding (training 3). All trainings are approximately 30 minutes in length Training 1 and
2 will be monitored in a MS teams session and via heart rate monitor (HRM), training
3 can be done at a time of the choosing of the participant and the heart rate
monitoring file will be sent to the researcher. Training 1 and 3 will be done using the
10-20-30 HIIT protocol which has been shown to be more effective compared to
continues moderate intensity training. This protocol can be used in different
activities in short it consists of 10 seconds of high intensity followed by 20 seconds of
moderate intensity followed by 30 seconds of very light intensity.
Inclusion criteria
* Surgical repair for Tetralogy of Fallot through transatrial-transpulmonary repair, below
the age of 2 years.
* Between 12 and 30 years of age
* Being followed in Erasmus MC, Sophia Childers hospital, Radboud UMC, Amalia
children’s hospital
* Does not comply with the “Nederlandse Norm Gezond Bewegen”
Exclusion criteria
* Inability to exercise or a contraindication for exercise such as long QT syndrome
* Contra indication for MRI such as a non MRI compatible pacemaker
* Ventricular outflow obstruction higher than 36 mmHg
* Developmental delay
* History of pulmonary valve replacement
* Use of beta blockers
* Documented cardiac arrhytmias
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9754 |
| CCMO | NL76553.078.21 |
| OMON | NL-OMON51183 |