Ischemic Preconditioning Claudication Study

Overview

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

Full Title of Study: “Walking Capacity of Patients With Claudication in Lower Extremities Following Ischemic Preconditioning”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 13, 2022

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.

Interventions

  • Other: Ischemic Preconditioning
    • See Ischemic Preconditioning Experimental group description
  • Other: Control Group
    • See Control group description

Arms, Groups and Cohorts

  • 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.
  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Muscle Fatigue
    • Time Frame: 2 weeks
    • 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.
  • Claudication onset time
    • Time Frame: 2 weeks
    • Subjects will be placed on a motorized treadmill and claudication onset time will be recorded in seconds.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical College of Wisconsin
  • Provider of Information About this Clinical Study
    • Principal Investigator: Matthew Durand, Assistant Professor – Medical College of Wisconsin

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