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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Ljubljana、斯洛文尼亚、1000
- University Medical Centre Ljubljana
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Maribor、斯洛文尼亚、2000
- University Medical Centre Maribor
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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实验性的：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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无干预：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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VO2peak on cardiopulmonary exercise testing (CPET)
大体时间：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
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean 24-hour systolic blood pressure
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Body composition
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 0120-101/2025-2711-4
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IPD 计划说明
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
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