Clinical trial NCT03511157: Ischemic Preconditioning Claudication Study
Official title: Walking Capacity of Patients With Claudication in Lower Extremities Following Ischemic Preconditioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Ischemia Vascular
Peripheral Arterial Disease
Peripheral Vascular Disease
Keywords: ischemic preconditioning
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak walking time
timeFrame: 2 weeks
Secondary outcomes:
measure: Muscle Fatigue
timeFrame: 2 weeks
measure: Claudication onset time
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert and the Medical College of Wisconsin
state: Wisconsin
Study officials:
References: