Effects of Exercise in Patients With Repaired Coarctation of the Aorta (KOREKT)
Effects of Exercise on Select Indicators of Cardiovascular Health in Patients With Repaired Coarctation of the Aorta
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ljubljana, Eslovenia, 1000
- University Medical Centre Ljubljana
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Maribor, Eslovenia, 2000
- University Medical Centre Maribor
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Outpatient HIIT
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. |
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. |
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Experimental: Home-based 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. |
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. |
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Sin intervención: Control (usual care)
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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VO2peak on cardiopulmonary exercise testing (CPET)
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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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.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Health-related quality of life
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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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.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Ratio of peak systolic blood pressure to peak workload (mmHg/W) on CPET
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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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.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean 24-hour systolic blood pressure
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of average systolic pressure during sleep and wakefulness, measured using 24-hour ambulatory blood pressure monitoring.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Echocardiographic parameters
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of standard echocardiographic measures of cardiac structure and function, including left ventricular global longitudinal strain (GLS).
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Endothelial function of the right radial artery (flow-mediated dilation, FMD)
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Ultrasound assessment of endothelial function of the right radial artery, measured by flow-mediated dilation (FMD).
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Heart rate variability
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of heart rate variability using high-resolution electrocardiography.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Biomarkers associated with vascular stiffness and atherosclerosis
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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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).
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Self-reported physical activity
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Self-reported physical activity level, assessed using the standardised International Physical Activity Questionnaire (IPAQ).
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body composition
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of body composition using bioelectrical impedance analysis.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Standard laboratory panel
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of standard laboratory parameters: electrolytes, renal function markers, liver function tests.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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NT-proBNP
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of NT-proBNP
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Extended lipid panel
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment extended lipid panel, including Lp(a).
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Thyroid hormone level
Periodo de tiempo: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Assessment of thyroid hormones.
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At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0120-101/2025-2711-4
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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