Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease With Critical Limb Ischemia or Tissue Loss. A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Mobility
研究概览
简要总结
Patients with peripheral arterial disease with symptoms of critical ischemia or reduced tissue loss have a very high mortality and morbidity rate. So far, treatment strategies focused on the preservation of life and limb by an open surgical or endovascular revascularization, together with cardiovascular risk management and pain relief. Important modifiable factors related to mortality and morbidity are not covered in the current national and international guidelines. This study investigates the effects on mobility, mortality and quality of life with supplementation of the standard treatment of critical limb ischemia with supervised exercise therapy. Also a reduction of cardiovascular risk by intensive risk factor management and lifestyle coaching will be taken in to account. The supervised exercise therapy will take place under the supervision of a trained physiotherapist.
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
- •Patients with peripheral arterial disease Rutherford stage 4 and 5, where it is possible to improve the vascularization of the affected leg with the help of an endovascular and / or open surgical vascular intervention.
- •Patients with both legs are affected, but the most severe leg does not exceed stage 5.
排除标准
- •Severe cardiopulmonary comorbidity (NYHA 4) and previous amputations of lower leg or thigh.
- •Patients with limited amputation of the toes can participate.
- •Insufficient understanding of the Dutch language.
- •No physiotherapy insurance.
研究组 & 干预措施
Supervised exercise therapy
Adequacy of initial therapy, Investigation degree of confusion and dementia, Preoperative preparation, Life-style coaching, Supervised Exercise therapy.
干预措施: Supervised Exercise Therapy (Behavioral)
Walking advice
Standard care and a oral walking advice.
结局指标
主要结局
Mobility
时间窗: 2 years
Pain free walking distance WIQ ALDS
次要结局
- Mortality(2 years)
- Quality of life(2 years)
研究者
Joep Teijink
prof. dr.
Catharina Ziekenhuis Eindhoven
