Effects of Exercise in Patients With Repaired Coarctation of the Aorta

N/AEnrolling By InvitationNCT07771023

University Medical Centre Ljubljana45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Coarctation of the Aorta Coarctation of Aorta

Interventions

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.

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.