Effects of Exercise in Patients With Repaired Coarctation of the Aorta

NCT07771023 | Enrolling By Invitation

• 1 other identifier: 0120-101/2025-2711-4
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Coarctation of the Aorta; Coarctation of Aorta

Keywords

exercise; HIIT; home-based exercise; exercise training; cardiopulmonary exercise testing; arterial stiffness; hypertensive reaction; congenital heart disease

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

Secondary Outcomes (6)

• Mean 24-hour systolic blood pressure

  At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

• Echocardiographic parameters

  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)

  At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

• Heart rate variability

  At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

• Biomarkers associated with vascular stiffness and atherosclerosis

  At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

Other Outcomes (5)

• Body composition

  At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

• Standard laboratory panel

  At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

• NT-proBNP

  At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

Study Arms (3)

Outpatient HIIT

EXPERIMENTAL

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)

Home-based HIIT

EXPERIMENTAL

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)

Control (usual care)

NO INTERVENTION

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.

Interventions

Outpatient high-intensity interval training (HIIT) BEHAVIORAL

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.

Outpatient HIIT

Home-based high-intensity interval training (HIIT) BEHAVIORAL

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.

Home-based HIIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• surgically repaired coarctation of the aorta,
• age at least 18 years, and
• signed informed consent form.

You may not qualify if:

• residual aortic stenosis (gradient across the narrowing \>20 mmHg),
• presence of ascending aortic aneurysm,
• unstable rhythm disturbances,
• unstable or low-threshold angina pectoris,
• NYHA class III or IV heart failure, and
• pregnancy.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University Medical Centre Maribor: collaborator

Study Sites (2)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

University Medical Centre Maribor

Maribor, 2000, Slovenia

Location

MeSH Terms

Conditions

Aortic Coarctation; Motor Activity; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

SL (2)