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

23 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

45

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
VO2peak on cardiopulmonary exercise testing (CPET)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean 24-hour systolic blood pressure
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body composition
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Medical Centre Ljubljana

Medewerkers

University Medical Centre Maribor

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 oktober 2027

Studie voltooiing (Geschat)

1 oktober 2027

Studieregistratiedata

Eerst ingediend

6 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 augustus 2026

Eerst geplaatst (Werkelijk)

18 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

23 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0120-101/2025-2711-4

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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