Ischemic Preconditioning Claudication Study

Walking Capacity of Patients With Claudication in Lower Extremities Following Ischemic Preconditioning

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Intermittent Claudication; Peripheral Vascular Disease; Ischemia Vascular
• Intervention / Treatment: Other: Ischemic Preconditioning; Other: Control Group

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert and The Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Ischemic Preconditioning; See Ischemic Preconditioning Experimental group description
Sham Comparator: 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	Other: Control Group; See Control group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak walking time	Subjects will be placed on a motorized treadmill and peak walking time will be recorded in seconds.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Fatigue	Subjects will perform muscle contractions for muscle groups of interest (knee extensors/flexors and dorsiflexors/plantarflexors). Contractions will be measured in newton-meters. The duration will be determined by the time subjects first feel pain and when the pain becomes too great to continue. The investigators will provide subjects with visual feedback on the monitor throughout the testing.	2 weeks
Claudication onset time	Subjects will be placed on a motorized treadmill and claudication onset time will be recorded in seconds.	2 weeks

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2018
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: ischemic preconditioning
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: PRO00031772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No