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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study 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 belowSelect...
I have peripheral artery disease (PAD) confirmed by a test or past treatment.
Select...
I have poor circulation in my legs, confirmed by a test or previous surgery.
Select...
I have experienced leg pain from walking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
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.
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
98,032 Total Patients Enrolled
1 Trials studying Intermittent Claudication
135 Patients Enrolled for Intermittent Claudication
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
259,937 Total Patients Enrolled
Milton S. Hershey Medical CenterOTHER
489 Previous Clinical Trials
2,798,281 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I started taking medication for leg pain when walking in the last 3 months.You have medical conditions that make it unsafe for you to exercise, as determined by the American College of Sports Medicine.I have peripheral artery disease (PAD) confirmed by a test or past treatment.I have severe tissue loss due to poor blood flow in my legs.I had surgery to improve blood flow in my limbs within the last month.I have leg pain at rest due to poor blood flow.My cancer is currently active.My kidneys are in the final stage of chronic disease.I have poor circulation in my legs, confirmed by a test or previous surgery.I do not have peripheral artery disease as per the tests and my medical history.I have experienced leg pain from walking.Your blood vessels cannot be compressed during testing.You have trouble with memory or thinking, scoring less than 24 on a simple test.
Research Study Groups:
This trial has the following groups:- Group 1: Home-Based Exercise
- Group 2: DASH Diet plus Home-Based Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts for the experiment still underway?
"Unfortunately, clinicaltrials.gov reports that this medical study is no longer accepting new candidates; the original post date was December 1st 2022 and it was last modified on February 25th 2022. However, there are 229 other trials currently recruiting patients."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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