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Diet and Exercise for Peripheral Artery Disease

N/A
Waitlist Available
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.
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

Summary

This trial will test whether the DASH diet, combined with a home-based exercise program, can improve vascular outcomes in patients with PAD.

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.Check my eligibility
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.See study design
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
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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:
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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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peak Walking Time
Physical Function subscale of quality of life from the Medical Outcomes Study Short-Form 36 questionnaire
Secondary outcome measures
6-minute walk distance
calf muscle oxygen saturation
high-sensitivity C-reactive protein

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.

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.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
457 Previous Clinical Trials
95,605 Total Patients Enrolled
1 Trials studying Intermittent Claudication
135 Patients Enrolled for Intermittent Claudication
Milton S. Hershey Medical CenterOTHER
500 Previous Clinical Trials
2,801,467 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,033,107 Total Patients Enrolled
5 Trials studying Intermittent Claudication
509 Patients Enrolled for Intermittent Claudication

Media Library

DASH Diet plus Home-Based Exercise Clinical Trial Eligibility Overview. Trial Name: NCT03845036 — N/A
Intermittent Claudication Research Study Groups: Home-Based Exercise, DASH Diet plus Home-Based Exercise
Intermittent Claudication Clinical Trial 2023: DASH Diet plus Home-Based Exercise Highlights & Side Effects. Trial Name: NCT03845036 — N/A
DASH Diet plus Home-Based Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03845036 — N/A
~100 spots leftby May 2027