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Exercise Program for Peripheral Arterial Disease (NICE Trial)

Q: Are researchers currently seeking participants for this experiment?

<p>According to clinicaltrials.gov, this specific medical trial is no longer enrolling participants as of November 9th 2023 and the initial posting date was January 22nd 2024. Despite its inactivity, there are currently 215 other trials actively seeking volunteers.</p>

N/A

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

NICE Trial 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.Check my eligibility

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.See study design

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.

NICE Trial Eligibility Criteria

Inclusion Criteria

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

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

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My ankle blood pressure drops significantly after exercise.

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I have leg pain when walking.

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I am 60 years old or older.

NICE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Calf Muscle Oxygen Saturation

Peak Walking Time

Secondary outcome measures

6-Minute Walk Distance

plasma C-Reactive Protein

NICE 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

~760

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityOTHER

299 Previous Clinical Trials

259,920 Total Patients Enrolled

University of OklahomaLead Sponsor

455 Previous Clinical Trials

97,510 Total Patients Enrolled

1 Trials studying Intermittent Claudication

135 Patients Enrolled for Intermittent Claudication

National Institute on Aging (NIA)NIH

1,668 Previous Clinical Trials

28,004,964 Total Patients Enrolled

5 Trials studying Intermittent Claudication

509 Patients Enrolled for Intermittent Claudication

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently seeking participants for this experiment?

"According to clinicaltrials.gov, this specific medical trial is no longer enrolling participants as of November 9th 2023 and the initial posting date was January 22nd 2024. Despite its inactivity, there are currently 215 other trials actively seeking volunteers."

Answered by AI

Recent research and studies

CirculationJournal

Efficacy of Quantified Home-based Exercise and Supervised Exercise in Patients with Intermittent Claudication

Gardner, Andrew W., Donald E. Parker, Polly S. Montgomery, Kristy J. Scott, and Steve M. Blevins. 2011. “Efficacy of Quantified Home-based Exercise and Supervised Exercise in Patients with Intermittent Claudication”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.110.963066.

Journal of the American Heart AssociationJournal

Step‐monitored Home Exercise Improves Ambulation, Vascular Function, and Inflammation in Symptomatic Patients with Peripheral Artery Disease: A Randomized Controlled Trial

Gardner, Andrew W., Donald E. Parker, Polly S. Montgomery, and Steve M. Blevins. 2014. “Step‐monitored Home Exercise Improves Ambulation, Vascular Function, and Inflammation in Symptomatic Patients with Peripheral Artery Disease: A Randomized Controlled Trial”. Journal of the American Heart Association. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/jaha.114.001107.

clinicaltrials.govStudy

The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease

Andrew Gardner 2024. "The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05712395.

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