Effects of diet and exercise on patients with peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a combined DASH dietary program and a home-based exercise regimen on patients with peripheral artery disease (PAD). Over three months, participants will be randomly assigned to either the combined intervention or a home-based exercise program alone. The study aims to measure improvements in walking distance, physical function quality of life, microvascular function, and inflammation markers. The hypothesis is that the combined approach will yield greater benefits than exercise alone.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

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.

Where it's running

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

Study contacts

• Principal investigator: Andrew Gardner, Ph.D. — Professor, Department of Medicine, Cardiology
• Study coordinator: Andrew Gardner, Ph.D.
• Email: andrew-gardner@ouhsc.edu
• Phone: 405-271-4742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.