RecruitingNot Applicable

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

United States150 participantsStarted 2024-09-16

Plain-language summary

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.

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. History of claudication,
✓. 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

✕. 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,
✕. non-compressible vessels (ABI \> 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 indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
✕. peripheral revascularization within one month prior to investigation,
✕. active cancer,
✕. end stage renal disease defined as stage 5 chronic kidney disease,

What they're measuring

Peak Walking Time

Timeframe: 3 months

Physical Function subscale of quality of life from the Medical Outcomes Study Short-Form 36 questionnaire

Timeframe: 3 months

Trial details

NCT IDNCT03845036

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-05-31

Contact for this trial

Andrew Gardner, Ph.D.

405-271-4742 andrew-gardner@ouhsc.edu

View on ClinicalTrials.gov More Claudication trials