Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Effects of Exercise in Patients With Repaired Coarctation of the Aorta (KOREKT)

23 sierpnia 2026 zaktualizowane przez: Kevin Pelicon, University Medical Centre Ljubljana

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.

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

45

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Słowenia
      • Ljubljana, Słowenia, 1000
        • University Medical Centre Ljubljana
      • Maribor, Słowenia, 2000
        • University Medical Centre Maribor

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Outpatient 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.
Eksperymentalny: 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.
Behawioralne: Home-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.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
VO2peak on cardiopulmonary exercise testing (CPET)
Ramy czasowe: 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.
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Health-related quality of life
Ramy czasowe: 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.
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
Ramy czasowe: 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.
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean 24-hour systolic blood pressure
Ramy czasowe: 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.
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Echocardiographic parameters
Ramy czasowe: 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).
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)
Ramy czasowe: 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).
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Heart rate variability
Ramy czasowe: 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.
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Biomarkers associated with vascular stiffness and atherosclerosis
Ramy czasowe: 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).
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Self-reported physical activity
Ramy czasowe: 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).
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Body composition
Ramy czasowe: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Assessment of body composition using bioelectrical impedance analysis.
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Standard laboratory panel
Ramy czasowe: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Assessment of standard laboratory parameters: electrolytes, renal function markers, liver function tests.
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
NT-proBNP
Ramy czasowe: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Assessment of NT-proBNP
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Extended lipid panel
Ramy czasowe: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Assessment extended lipid panel, including Lp(a).
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Thyroid hormone level
Ramy czasowe: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Assessment of thyroid hormones.
At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University Medical Centre Ljubljana

Współpracownicy

University Medical Centre Maribor

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

1 października 2027

Ukończenie studiów (Szacowany)

1 października 2027

Daty rejestracji na studia

Pierwszy przesłany

6 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

18 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 0120-101/2025-2711-4

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

All IPD that underlie results in a publication will be shared upon reasonable request.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj