Primary Objective: To examine the effect of an online based exercise training protocol on ventriculo-arterial coupling , as assessed by pulse wave velocity and wave reflection patterns in the aorta and pulmonary artery in patients operated for…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Decrease in pulse wave velocity in the aorta and pulmonary artery measured by
MRI.
Secondary outcome
1. 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 as
measure by Schafer et al. (1) 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. Oon a commercially available
ultrasound platform. Echocardiography Wwill 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 atriovernricular valve regurgitation. Patient data can be compared to
existing local reference data of healthy volunteers.
3. Changes in body fat percentage, height and weight and their derivates BMI
and BSA
4. Questionnaires of QoL
• Will be assed using CHQ-PF28, CHQ-CF45, SF36 (for persons above 18) and
SQUASH)
Background summary
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.
Study objective
Primary Objective: To examine the effect of an online based exercise training
protocol on ventriculo-arterial coupling , as assessed by pulse wave velocity
and wave reflection patterns in the aorta and pulmonary artery in patients
operated for 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.
Intervention
12 weeks of online based interval training 3 times a week.
Study burden and risks
Children and young adults who will be included in the study have no
restrictions in their level of physical exercise. In daily life they are
subject to peak physical exercise levels. In previous projects (METC 2006-310,
2009-033, 2009-134, 2014-326) in similar patients we have not encountered any
untoward effects in exercise testing, nor in exercise training (METC 2009-134).
The effects of exercise training will be evaluated. Exercise training in
similar patients has been performed without serious adverse effects. (2-4) We
therefore do not expect an increased risk for the patients. Furthermore, these
patients will have had detailed evaluation, including exercise testing, MRI and
echocardiography before they enter into exercise training. The burden of the
study procedures is limited. Procedures are those routinely performed during
regular follow-up in these patient categories, and are not harmful. Exercise
training is a recommended part of standard care during follow-up after repair
of tetralogy of Fallot. In earlier, similar studies in children with congenital
heart disease we did not encounter or notice any untoward effects of imaging
procedures or exercise testing. (2, 5, 6) Heart rhythm disturbances have been
reported to occur during exercise testing. In previous studies no (severe)
adverse effects of exercise training have been reported in patients with
congenital heart disease.
Wytenaweg 80
Rotterdam 3000 CB
NL
Wytenaweg 80
Rotterdam 3000 CB
NL
Listed location countries
Age
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 ACAHA (academisch centrum voor aangeboren hartafwijkingen,
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
• Ventricular outflow obstruction (gradient of over 36 mmHg)
• Developmental delay
• Standard contra-indications for MRI
• Use of beta blockers
• Documented cardiac arrhytmias
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL76553.078.21 |