Walking Capacity of Patients With Claudication in Lower Extremities Following Ischemic Preconditioning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Peak walking time
研究概览
简要总结
This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication.
详细描述
This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication. Peripheral arterial disease (PAD) is a circulatory condition in which large supply blood vessels narrow, reducing oxygen and nutrient distribution to peripheral tissues. IPC protects against tissue damage caused by ischemia and can improve functional capacity in patients recovering from stroke; however, the benefit of ischemic preconditioning in patients with peripheral arterial disease remains unclear.
The investigators predict that ischemic preconditioning (IPC) will delay claudication onset time (COT), increase peak walking time (PWT) and improve muscle strength in patients with intermittent claudication.
The investigators will determine whether IPC improves claudication onset time (COT) and peak walking time (PWT) in patients with intermittent claudication. A motorized treadmill will be employed to assess COT and PWT.
The investigators will determine whether IPC can improve muscle strength and time to pain onset in the affected leg of patients with intermittent claudication. These metrics will be assessed quantitatively using a Biodex™ dynamometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •between ages of 18-80
- •able to give informed consent
- •presence of vascular disease with intermittent claudication
排除标准
- •age < 18 or >80
- •unable to give informed consent
- •presence of vascular disease with leg pain at rest, ischemic ulceration, or gangrene
- •unable to walk on a treadmill
- •unable to perform or tolerate ischemic preconditioning
- •unable to follow commands
- •exercise capacity limited by symptoms of angina, congestive heart failure, chronic obstructive pulmonary disease, or arthritis to be determined by PI
- •patients who have undergone vascular surgery or endovascular surgery in the previous year on the affected leg
- •history of major lower extremity amputation
- •history of major psychiatric disorder
- •history of uncontrolled hypertension
研究组 & 干预措施
Ischemic Preconditioning
A standard blood pressure cuff will be placed on the right or left thigh, depending on the affected side, to occlude blood flow. The cuff will be inflated to 225 mmHg to prevent blood flow. Each session will consist of 4 cycles of 5 minute IPC applications, followed by 5 minutes of reperfusion for a total of 35 minutes.
干预措施: Ischemic Preconditioning (Other)
Control
The sham intervention protocol will be identical to the IPC protocol except blood flow to the affected leg is unchanged as cuff pressure will be raised to between the venous and diastolic pressures
干预措施: Control Group (Other)
结局指标
主要结局
Peak walking time
时间窗: 2 weeks
Subjects will be placed on a motorized treadmill and peak walking time will be recorded in seconds.
次要结局
- Claudication onset time(2 weeks)
- Muscle Fatigue(2 weeks)
研究者
Matthew Durand
Assistant Professor
Medical College of Wisconsin