Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT03845036

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Led by University of Oklahoma · Updated on 2026-04-17

150

Participants Needed

1

Research Sites

245 weeks

Total Duration

On this page

Sponsors

U

University of Oklahoma

Lead Sponsor

M

Milton S. Hershey Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a home-based exercise program, quantified by a step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.

CONDITIONS

Official Title

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of claudication
  • Presence of peripheral artery disease, defined by one or more of the following: resting ankle-brachial index (ABI) less than 0.90, more than 20% decrease in ABI after heel-rise exercise if resting ABI is above 0.90, or previous peripheral revascularization
Not Eligible

You will not qualify if you...

  • No peripheral artery disease, defined by resting ABI greater than 0.90, less than 20% decrease in ABI after heel-rise exercise, and no history of peripheral revascularization
  • Non-compressible vessels (ABI greater than 1.40)
  • Rest pain due to PAD (Fontaine stage III; Rutherford Grade II)
  • Tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III)
  • Use of medications for intermittent claudication (cilostazol or pentoxifylline) started within three months before the study
  • Peripheral revascularization within one month before the study
  • Active cancer
  • End stage renal disease (stage 5 chronic kidney disease)
  • Medical conditions that contraindicate exercise as per the American College of Sports Medicine
  • Cognitive dysfunction with mini-mental state examination score below 24
  • Failure to complete baseline tests within three weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

O'Donoghue Research Building, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73117

Actively Recruiting

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Research Team

A

Andrew Gardner, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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