Comparative Effect of Water-based and Land-based Exercise Training on Exercise Capacity and Other Selected Cardiovascular Parameters in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing
研究概览
简要总结
The aim of the study is to compare the effect of water-based and land-based exercise training, and usual care (no exercise training) in patient with coronary artery disease, on exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal activity, activated hemostasis and inflammation.
详细描述
Swimming and other water-based physical activities represent an effective form of aerobic-dynamic exercise. However, existing guidelines mainly advise caution when recommending water-based activities to patients with coronary artery disease. To date, safety and efficacy of short-term water-based exercise in patients with coronary artery diseases have only scarcely been addressed.
Cardiovascular rehabilitation is an integral part of management after a myocardial infarction or coronary procedure. Most rehabilitation programs are exercise-based, since the beneficial effects of physical activity undisputed, and corroborated by a large body of evidence.
Most rehabilitation programs are exercise-based, since the beneficial effects of physical activity undisputed, and corroborated by a large body of evidence.
Research has mainly been focused on the impact assessment of the standard forms of physical training, they studied various forms of physical exercise, mainly land-based. No previous study has reported on the effect of exercise in water as an integral element of standard cardiac rehabilitation in coronary patients on exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal activity, activated hemostasis and inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with coronary artery disease after myocardial infarction or myocardial revascularization (percutaneous coronary procedure or surgical revascularization)
排除标准
- •unstable coronary artery disease, ejection fraction of the left ventricle of 40% or less, heart valve defect that dictate specific treatment, condition after valve replacement, heart rhythm disorders, the presence of a permanent pacemaker, contraindications to exercise, inability to perform exercise testing, mental retardation, severe anemia, obstructive/restrictive lung disease severe degree, recent thrombo embolic events, age over 80 years.
研究组 & 干预措施
Water-based exercise training group
Intervention: Patients randomized to the "water-based exercise training group" will undergo water-based exercise training. The immersed exercise will include two session of aerobic (water-based) and calisthenic exercise per day, six days of a week, each lasting 30 minutes.
干预措施: water-based exercise training (Other)
Land-based exercise training group
Patients randomized to the "land-based exercise training group" will undergo exercise training which will include two aerobic and calisthenic exercise session per day, six days of a week, lasting 30 minutes
干预措施: land-based exercise training (Other)
Control group (usual care)
Control group: patients randomized in control group will have usual care with no exercise
结局指标
主要结局
Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing
时间窗: 14 days
次要结局
- Change of arrhythmogenic potential estimated by high resolution ECG(14 days)
- Change in heart rate variability, estimated by high resolution ECG(14 days)
- Change of N terminal - proBNP serum concentration value , measured in ng/l(14 days)
- Change of the D-dimer serum concentration value, measured in microg/l(14 days)
- Change of flow-mediated dilation of brachial artery measured in %(14 days)
- Change of the C-reactive protein serum concentration value, measured in g/l(14 days)
- Change in fibrinogen serum concentration value, measured in g/l(14 days)
- Change of from-the-questionnaire-obtained quality of life, measured in points(14 days)
研究者
Borut Jug
Assistant professor
University Medical Centre Ljubljana