An interventional study of Outpatient high-intensity interval training (HIIT) and Home-based high-intensity interval training (HIIT) in Coarctation of the Aorta and Coarctation of Aorta, sponsored by University Medical Centre Ljubljana. Enrolling by invitation at 2 sites in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Prevention
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's planned enrollment of 45 is close to the median of 45 across 19 interventional studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anticipated number of patients: 15. Participants will complete a structured high-intensity interval training (HIIT) programme performed in an outpatient setting. Intensity and progression are identical to the home-based HIIT arm.
Behavioral: Outpatient high-intensity interval training (HIIT)
Anticipated number of patients: 15. Participants will complete a structured high-intensity interval training (HIIT) programme performed independently at home. Intensity and progression are identical to the outpatient HIIT arm.
Behavioral: Home-based high-intensity interval training (HIIT)
Anticipated number of patients: 15. Participants will receive usual care, consisting of general counselling on physical activity performed at home, without a structured or supervised exercise training programme.
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.
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.
VO2peak on cardiopulmonary exercise testing (CPET)
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.
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Health-related quality of life
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.
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Ratio of peak systolic blood pressure to peak workload (mmHg/W) on CPET
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.
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Mean 24-hour systolic blood pressure
Assessment of average systolic pressure during sleep and wakefulness, measured using 24-hour ambulatory blood pressure monitoring.
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Echocardiographic parameters
Assessment of standard echocardiographic measures of cardiac structure and function, including left ventricular global longitudinal strain (GLS).
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Endothelial function of the right radial artery (flow-mediated dilation, FMD)
Ultrasound assessment of endothelial function of the right radial artery, measured by flow-mediated dilation (FMD).
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Heart rate variability
Assessment of heart rate variability using high-resolution electrocardiography.
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Biomarkers associated with vascular stiffness and atherosclerosis
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).
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Self-reported physical activity
Self-reported physical activity level, assessed using the standardised International Physical Activity Questionnaire (IPAQ).
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Body composition
Assessment of body composition using bioelectrical impedance analysis.
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Standard laboratory panel
Assessment of standard laboratory parameters: electrolytes, renal function markers, liver function tests.
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
NT-proBNP
Assessment of NT-proBNP
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Extended lipid panel
Assessment extended lipid panel, including Lp(a).
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Thyroid hormone level
Assessment of thyroid hormones.
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Plan to share: Yes — All IPD that underlie results in a publication will be shared upon reasonable request.
Supporting information: Study protocol, Informed consent form
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