Coarctation of Aorta, Coarctation of the Aorta
Conditions
Keywords
exercise, HIIT, home-based exercise, exercise training, cardiopulmonary exercise testing, arterial stiffness, hypertensive reaction, congenital heart disease
Brief summary
This interventional study will investigate the effects of high-intensity interval training (HIIT) in adults with repaired coarctation of the aorta. Participants will be randomised into three groups: HIIT performed at home, HIIT performed in a supervised outpatient setting, or a control group receiving usual care. The two HIIT protocols will be identical in intensity and progression, individually prescribed for each patient. The study will evaluate the effects of HIIT on exercise capacity, health-related quality of life, blood pressure response to exercise, and other select measures of cardiovascular health, including vascular stiffness and endothelial function. In addition, the study will examine the acute effects of a single exercise session on arterial stiffness.
Interventions
BEHAVIORALOutpatient high-intensity interval training (HIIT)
A structured exercise programme performed under direct supervision in an outpatient/clinical setting on a stationary bicycle or treadmill, consisting of 36 one-hour sessions over 2-4 months (approximately 2-3 sessions per week). Each session will comprise 8 five-minute intervals, each consisting of 2 minutes at 85-95% of the heart rate reached at VO2peak, followed by 3 minutes of active recovery. The interval block will be preceded by a 5-minute active warm-up and followed by a 5-minute active cool-down. Interval intensity will be individually determined for each patient.
BEHAVIORALHome-based high-intensity interval training (HIIT)
A structured exercise programme performed independently at home, consisting of 36 one-hour sessions over 2-4 months (approximately 2-3 sessions per week). Each session will comprise 8 five-minute intervals, each consisting of 2 minutes at 85-95% of the heart rate reached at VO2peak, followed by 3 minutes of active recovery. The interval block will be preceded by a 5-minute active warm-up and followed by a 5-minute active cool-down. Interval intensity will be individually determined for each patient.
Sponsors
University Medical Centre Ljubljana
University Medical Centre Maribor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* surgically repaired coarctation of the aorta, * age at least 18 years, and * signed informed consent form.
Exclusion criteria
* residual aortic stenosis (gradient across the narrowing \>20 mmHg), * presence of ascending aortic aneurysm, * recent major cardiovascular event or other event requiring hospitalization (event less than 2 months before inclusion), * unstable rhythm disturbances, * unstable or low-threshold angina pectoris, * NYHA class III or IV heart failure, and * pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2peak on cardiopulmonary exercise testing (CPET) | At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline. | Hypothesis: The outpatient high-intensity interval training (HIIT) programme improves aerobic capacity (measured by VO2peak) more than a home-based HIIT program or usual care. |
| Health-related quality of life | At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline. | Hypothesis: The outpatient high-intensity interval training (HIIT) programme improves health-related quality of life, assessed using the standardised SF-36 and EQ-5D questionnaires, more than a home-based HIIT programme or usual care. |
| Ratio of peak systolic blood pressure to peak workload (mmHg/W) on CPET | At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline. | Hypothesis: The outpatient high-intensity interval training (HIIT) programme reduces the ratio between peak systolic blood pressure and peak workload achieved during exercise testing more than a home-based HIIT programme or usual care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24-hour systolic blood pressure | At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline. | Assessment of average systolic pressure during sleep and wakefulness, measured using 24-hour ambulatory blood pressure monitoring. |
| Echocardiographic parameters | At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline. | Assessment of standard echocardiographic measures of cardiac structure and function, including left ventricular global longitudinal strain (GLS). |
| Endothelial function of the right radial artery (flow-mediated dilation, FMD) | At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline. | Ultrasound assessment of endothelial function of the right radial artery, measured by flow-mediated dilation (FMD). |
| Heart rate variability | At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline. | Assessment of heart rate variability using high-resolution electrocardiography. |
| Biomarkers associated with vascular stiffness and atherosclerosis | At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline. | Assessment of circulating biomarkers associated with vascular stiffness and atherosclerosis, including atrial natriuretic peptide (ANP), growth/differentiation factor 15 (GDF-15), matrix metalloproteinase 1 (MMP-1), interleukin-33 receptor (IL-33/ST2), brain-derived neurotrophic factor (BDNF), galectin-3, myeloperoxidase, and tissue inhibitor of metalloproteinase 1 (TIMP-1). |
| Self-reported physical activity | At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline. | Self-reported physical activity level, assessed using the standardised International Physical Activity Questionnaire (IPAQ). |
Countries
Slovenia
Outcome results
None listed