Effects of Exercise on Select Indicators of Cardiovascular Health in Patients With Repaired Coarctation of the Aorta
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- VO2peak on cardiopulmonary exercise testing (CPET)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •surgically repaired coarctation of the aorta,
- •age at least 18 years, and
- •signed informed consent form.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
VO2peak on cardiopulmonary exercise testing (CPET)
时间窗: 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.
Health-related quality of life
时间窗: 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.
Ratio of peak systolic blood pressure to peak workload (mmHg/W) on CPET
时间窗: 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.
次要结局
- 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.)
- Self-reported physical activity(At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.)
研究者
Kevin Pelicon
MD
University Medical Centre Ljubljana