What side effects are associated with this type of intervention?

Common treatments for intermittent claudication, such as dietary changes and exercise programs, generally have minimal side effects. Dietary changes like the DASH diet can cause gastrointestinal discomfort, such as bloating or gas, due to increased fiber intake. Exercise programs, especially those involving walking to the point of claudication, can result in muscle soreness and fatigue. These side effects are usually mild and temporary, with more intensive exercise potentially leading to more pronounced muscle pain or injury if not properly managed.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of intermittent claudication, including cilostazol and pentoxifylline, which improve walking distance and alleviate symptoms. Cilostazol, a phosphodiesterase inhibitor, has been shown to increase walking distances by improving blood flow. Pentoxifylline, a xanthine derivative, enhances red blood cell flexibility and reduces blood viscosity. In addition to pharmacological treatments, lifestyle interventions such as the DASH dietary program and home-based exercise programs are recommended to lower blood pressure, improve cardiovascular health, and enhance vascular function and physical fitness in patients with peripheral artery disease.

What other types of research exist?

Promising alternatives to the DASH Dietary Program and Home-Based Exercise Program for Intermittent Claudication patients include: 1) Mediterranean Diet: Rich in fruits, vegetables, whole grains, and healthy fats, this diet has been shown to improve cardiovascular health and reduce inflammation. 2) Supervised Exercise Therapy: Structured programs, particularly those involving treadmill walking or lower extremity resistance training, have demonstrated significant improvements in walking distance and quality of life. 3) High-Intensity Interval Training (HIIT): Short bursts of intense exercise followed by rest periods can enhance cardiovascular fitness and walking performance. 4) Plant-Based Diets: Emphasizing whole, plant-based foods can lower blood pressure and improve vascular health. These alternatives offer evidence-based benefits and can be tailored to individual patient needs.

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Diet and Exercise for Peripheral Artery Disease

N/A

Recruiting

Led By Andrew Gardner, Ph.D.

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Must not have

Tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III)

Rest pain due to PAD (Fontaine stage III; Rutherford Grade II)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a healthy diet combined with home walking exercises can help people with poor leg blood flow walk better and feel better overall. The diet aims to make blood vessels healthier, while the exercise improves blood flow and leg strength.

Who is the study for?

This trial is for individuals with Peripheral Artery Disease (PAD), specifically those who have leg pain during walking, and have either abnormal ankle-brachial index (ABI) readings or a history of procedures to improve blood flow. It's not for people without PAD, those with severe PAD symptoms like rest pain or tissue loss, recent revascularization, active cancer, certain chronic conditions, cognitive dysfunction, or on recent claudication medication.

What is being tested?

The study tests if a specific diet called the DASH Diet combined with home-based exercise improves physical function in PAD patients. Participants are randomly assigned to follow this regimen or just the exercise program for three months while their steps and vascular health are monitored.

What are the potential side effects?

Since the interventions involve diet changes and exercise rather than medications or invasive procedures, side effects may include muscle soreness from new exercises and potential dietary adjustment issues such as changes in bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have peripheral artery disease (PAD) confirmed by a test or past treatment.

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I have poor circulation in my legs, confirmed by a test or previous surgery.

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I have experienced leg pain from walking.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe tissue loss due to poor blood flow in my legs.

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I have leg pain at rest due to poor blood flow.

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My cancer is currently active.

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My kidneys are in the final stage of chronic disease.

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I do not have peripheral artery disease as per the tests and my medical history.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak Walking Time

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

Secondary study objectives

6-minute walk distance

calf muscle oxygen saturation

high-sensitivity C-reactive protein

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DASH Diet plus Home-Based ExerciseExperimental Treatment1 Intervention

The DASH dietary program consists of a diet emphasizing foods rich in fruits, vegetables, whole grains, and low-fat dairy, in which patients record daily servings of fruits and vegetables. The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.

Group II: Home-Based ExerciseActive Control1 Intervention

The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for intermittent claudication include exercise therapy and dietary modifications. Exercise therapy, such as supervised treadmill walking, improves walking ability and reduces symptoms by enhancing blood flow, increasing peak oxygen consumption, and promoting vascular health. Dietary changes, like the DASH diet, lower blood pressure and improve cardiovascular health by reducing cholesterol levels and improving endothelial function. These mechanisms are crucial for intermittent claudication patients as they directly address the underlying issues of reduced blood flow and muscle ischemia, thereby improving walking distance, reducing pain, and enhancing overall quality of life.

Benefit of exercise conditioning for patients with peripheral arterial disease.Clinical impact of exercise in patients with peripheral arterial disease.