The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Launched by UNIVERSITY OF OKLAHOMA · Feb 15, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating how a specific diet and exercise program can help improve the health of patients with Peripheral Artery Disease (PAD), which often causes pain when walking due to reduced blood flow. For this study, researchers are looking for participants who have a history of claudication (pain in the legs when walking) and meet certain criteria to confirm they have PAD. Eligible participants should be between the ages of 21 and 914, and the study welcomes individuals of all genders.

Participants in the trial will follow the DASH dietary program, which emphasizes fruits, vegetables, whole grains, and lean proteins, along with a home-based exercise routine that will be monitored using a step activity tracker. The study lasts for three months, and those who join will be helping researchers understand if these lifestyle changes can significantly improve exercise capacity and overall vascular health in people with PAD. It's important to note that individuals with more severe PAD symptoms, certain medical conditions, or recent treatments may not qualify for this study.

Gender

ALL

Eligibility criteria

• 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.