The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Description

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

Claudication, Peripheral Artery Disease

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Study Overview

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Study Details

Study overview

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.

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Condition
Claudication
Intervention / Treatment

-

Contacts and Locations

Oklahoma City

O'Donoghue Research Building, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 73117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. History of claudication,
  • 2. Presence of PAD, defined by meeting at least one of the following criteria (ABI at rest \< 0.90, or \> 20% decrease in ABI following a heel-rise exercise test in patients with a normal ABI at rest (\> 0.90), or history of peripheral revascularization.
  • 1. absence of PAD, defined by meeting all of the following 3 criteria (ABI at rest \> 0.90), \< 20% decrease in ABI following a heel-rise exercise test, and no history of peripheral revascularization,
  • 2. non-compressible vessels (ABI \> 1.40),
  • 3. rest pain due to PAD (Fontaine stage III; Rutherford Grade II),
  • 4. tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III),
  • 5. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
  • 6. peripheral revascularization within one month prior to investigation,
  • 7. active cancer,
  • 8. end stage renal disease defined as stage 5 chronic kidney disease,
  • 9. medical conditions that are contraindicative for exercise according to the American College of Sports Medicine,
  • 10. cognitive dysfunction (mini-mental state examination score \< 24), and
  • 11. failure to complete the baseline tests within three weeks.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Oklahoma,

Andrew Gardner, Ph.D., PRINCIPAL_INVESTIGATOR, Professor, Department of Medicine, Cardiology

Study Record Dates

2027-05-31