← Back to Search

Other

Exercise Program for Peripheral Arterial Disease (NICE Trial)

N/A

Recruiting

Led By Andrew W. Gardner, Ph.D

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol

An ABI <= 0.90 at rest or > 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test

Must not have

Absence of PAD (ABI > 0.90 at rest and ankle systolic blood pressure < 20% decrease after exercise)

Peripheral revascularization within one month prior to investigation, or peripheral revascularization performed during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program to improve exercise and blood flow in people with PAD.

Who is the study for?

This trial is for individuals aged 60 or older with Peripheral Artery Disease (PAD) who experience leg pain during walking, confirmed by a treadmill test and an Ankle-Brachial Index (ABI) of <=0.90. Candidates should not have started certain PAD medications recently, had recent revascularization, or have conditions that could affect exercise tolerance other than PAD.

What is being tested?

The study tests the Non-Ischemic Exercise (NICE) program's effectiveness over three months in improving exercise capacity and vascular health in patients with PAD. Participants are randomly assigned to either the NICE program or a control group to compare outcomes.

What are the potential side effects?

Since this intervention involves exercise, potential side effects may include muscle soreness, fatigue, and increased leg pain initially as participants adapt to the new activity regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have leg pain when walking, confirmed by a treadmill test.

Select...

My ankle blood pressure drops significantly after exercise.

Select...

I have leg pain when walking.

Select...

I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My blood flow in legs is normal, both at rest and after exercise.

Select...

I have had or will have surgery to improve blood flow to my limbs.

Select...

I have pain-free leg artery disease confirmed by a treadmill test.

Select...

I couldn't finish the initial treatment phase in 3 weeks.

Select...

My finger's oxygen level is below 95% due to lung issues affecting muscle oxygen.

Select...

My ability to exercise is limited due to a condition other than PAD.

Select...

My condition is stage 5 chronic kidney disease.

Select...

My cancer is currently active.

Select...

I have tissue loss due to poor blood flow in my legs.

Select...

I have pain in my legs at rest due to poor blood flow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Calf Muscle Oxygen Saturation

Peak Walking Time

Secondary study objectives

6-Minute Walk Distance

plasma C-Reactive Protein

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-Ischemic Exercise (NICE) exercise programExperimental Treatment1 Intervention

Patients will perform supervised treadmill walking for 3 months. Patients randomized to the NICE program will walk intermittently at a slow speed of approximately 1.4 mph for only 2-3 minute bouts that do not elicit claudication pain.

Group II: Standard exercise programActive Control1 Intervention

Patients will perform supervised treadmill walking for 3 months. Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~820

0 / 14Eligibility criteria met