Ischemic Preconditioning Claudication Study

Medical College of Wisconsin

Status: Completed

Conditions: Peripheral Vascular Disease; Intermittent Claudication; Peripheral Arterial Disease; Ischemia Vascular

Treatments: Other: Control Group; Other: Ischemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03511157

PRO00031772

Details and patient eligibility

About

This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. between ages of 18-80
2. able to give informed consent
3. presence of vascular disease with intermittent claudication

Exclusion criteria

1. age < 18 or >80
2. unable to give informed consent
3. presence of vascular disease with leg pain at rest, ischemic ulceration, or gangrene
4. pregnancy
5. unable to walk on a treadmill
6. unable to perform or tolerate ischemic preconditioning
7. unable to follow commands
8. exercise capacity limited by symptoms of angina, congestive heart failure, chronic obstructive pulmonary disease, or arthritis to be determined by PI
9. patients who have undergone vascular surgery or endovascular surgery in the previous year on the affected leg
10. history of major lower extremity amputation
11. history of major psychiatric disorder
12. history of uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Ischemic Preconditioning

Experimental group

Description:

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.

Treatment:

Other: Ischemic Preconditioning

Control

Sham Comparator group

Description:

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

Treatment:

Other: Control Group