Additional Exercise Therapy in Patients With Peripheral Arterial Disease: The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- maximum walking distance
研究概览
简要总结
The objective of this study is to investigate what the value is of SET after a radiological or surgical intervention for peripheral arterial disease in the aorto-iliacal, femoro-popliteal and crural segments in comparison with a control group.
详细描述
Treatment of peripheral arterial disease consists of vascular risk factor management and, dependent on the severity of the disease, exercise therapy, and either radiological or surgical intervention. After invasive treatment, many patients keep complaints, or complaints return, despite the fact that the treated segment is still patent.
Supervised exercise therapy (SET) has been proved to be an effective treatment for patients with intermittent claudication, with a significant increase in maximal walking distance. Further, exercise therapy contributes to an improvement in quality of life, a delay in disease progression and an improvement of the vascular risk profile.
Research on SET after an invasive intervention is rare. In one study, the effect of SET after surgical treatment on walking distance was determined. The initial claudication distance increased significantly in the exercise group, compared with surgical treatment alone.
In June 2004, the Network for Exercise Therapy Parkstad (NETP) was implemented in Heerlen and its environs. The physiotherapists of this network provide community based SET according to the protocol of the Royal Dutch Society of Physiotherapy. The web based database, which is a part of the NETP, was retrospectively searched for patients who started SET within 2 months after a radiological or surgical intervention. Seventeen patients fulfilled these criteria, and after 1, 3, 6 and 12 months, there was a significant increase in both initial claudication distance (ICD) and absolute claudication distance (ACD).
The expectation is that SET, immediately offered after an invasive intervention for peripheral arterial disease, influences walking distance and quality of life. Further, a positive influence on vascular risk factors and the frequency of re-interventions is expected.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PAD stage 2 or 3 according to Fontaine,
- •Surgical or radiological intervention indicated
排除标准
- •No insurance for physiotherapy,
- •Insufficient command of the Dutch language,
- •Serious cardiopulmonary limitations (NYHA 3-4,)
- •Major amputation,
- •Serious co-morbidity prohibiting physical training
结局指标
主要结局
maximum walking distance
时间窗: one year
次要结局
- quality of life fontaine stage ankle brachial index vascular risk factors re-interventions patency mortality.(one year)
