Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Individuals With Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change of maximum walking distance, measured in metres
研究概览
简要总结
In this controlled trial, patients with peripheral arterial disease will be randomized to either maximal walking, submaximal walking, or usual care groups.
详细描述
Exercise training (walking) is a recommended therapeutic intervention for patients with peripheral arterial disease (PAD). Studies have shown that exercise training improves walking distance, pain-free walking distance, endothelial function and quality of life in these patients. However, to date the most effective exercise training option in terms of improvement of cardiovascular parameters has not been clearly identified. In this controlled trial, patients with PAD will be randomized to either maximal walking group, submaximal walking group, or usual care. The aim of the study is to compare the effect of maximal vs. submaximal walking training programmes on i) walking ability, ii) vascular function, iii) arrhythmogenic potential, iv) parameters of inflammation, hemostasis and heart failure severity, v) health-related quality of life in individuals with PAD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed peripheral arterial disease,
- •Fontaine stage II,
- •not included in a cardiovascular rehabilitation programme for at least 3 months.
排除标准
- •contraindications for physical activity,
- •uncontrolled dysrhythmias,
- •uncontrolled heart failure (New York Heart Association (NYHA) stage IV),
- •unstable coronary or other arterial disease,
- •intellectual development disorder,
- •pregnancy.
研究组 & 干预措施
Maximal walking group
Patients to be randomized to the 'maximal walking group' will have exercise training sessions 3 times per week for a period of 12 weeks. They will undergo an exercise training programme consisting of 60 minutes of repetitive interval muscle training/walking up to the point of pain-free walking distance.
干预措施: Exercise training (Other)
Submaximal walking group
Patients to be randomized to the 'submaximal walking group' will have exercise training sessions 3 times per week for a period of 12 weeks. They will undergo an exercise training programme consisting of 60 minutes of repetitive interval muscle training/walking up to 2/3 of pain-free walking distance.
干预措施: Exercise training (Other)
Usual care group
Patients to be randomized to the 'usual care group' will undergo standard care for 12 weeks.
结局指标
主要结局
Change of maximum walking distance, measured in metres
时间窗: 3 months
Determined by treadmill walking test.
次要结局
- Change of the value of blood C-reactive protein, measured in mg/l(3 months)
- Change of the ECG waves(3 months)
- Change of the heart rate variability(3 months)
- Change of the arterial stiffness coefficient(3 months)
- Change of the value of blood fibrinogen, measured in g/l(3 months)
- Change of the value of blood D-dimer, measured in microg/l(3 months)
- Change of from-the-questionnaire-obtained quality of life, measured in points(3 months)
- Change of the value of blood N terminal-proBNP, measured in ng/l(3 months)
- Change of flow-mediated dilatation of the brachial artery, measured in %(3 months)
研究者
Borut Jug
Assistant Professor
University Medical Centre Ljubljana