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临床试验/NCT02110251
NCT02110251终止不适用

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

Catharina Ziekenhuis Eindhoven4 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

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

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

Experimental

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

No Intervention

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

发起方
Catharina Ziekenhuis Eindhoven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joep Teijink

prof. dr.

Catharina Ziekenhuis Eindhoven

研究点 (4)

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