Phase
Condition
Aging
Peripheral Arterial Occlusive Disease
Claudication
Treatment
Home-Based Exercise
Supervised Treadmill Exercise
Nitrate-rich beetroot Juice
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
First, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as either:
An ABI <= 0.90 at baseline.
Vascular lab evidence of PAD (such as a toe brachial pressure less than or equal to 0.70 or an ankle brachial index less than or equal to 0.90), or angiographicevidence of PAD defined as at least 70% stenosis of an artery supplying the lowerextremities.
An ABI of >0.90 and <1.00 who experience a 20% or greater drop in ABI in either legafter the heel-rise test.
Exclusion
Exclusion Criteria:
Above- or below-knee amputation
Limb-threatening ischemia defined as an ABI <0.40 with symptoms of rest pain
Wheelchair confinement or requiring a walker to ambulate
Walking is limited by a condition other than PAD
Current foot ulcer on bottom of foot
Unwilling to drink beetroot juice
Unwilling to accept randomization into either group (home based exercise orsupervised exercise)
Planning to engage in new walking exercise outside of the study or unwilling torefrain from new walking exercise activity during the trial.
Already exercising at a level consistent with exercise intervention.
End-stage kidney disease (ESKD) associated with the need for dialysis.
Planned major surgery, coronary or leg revascularization during the next six months
Major surgery, coronary or leg revascularization or major cardiovascular event inthe previous three months
Major medical illness including lung disease requiring oxygen, Parkinson's disease,a life-threatening illness with life expectancy less than six months, or cancerrequiring treatment in the previous two years. [NOTE: potential participants maystill qualify if they have had treatment for an early stage cancer in the past twoyears and the prognosis is excellent. Participants who require oxygen only at nightmay still qualify.]
Mini-Mental Status Examination (MMSE) score < 23 or dementia. However, if the MMSEis < 23 and the Principal Investigator evaluation determines that the lower score isrelated to language barriers or education level, the Principal Investigator hasdiscretion to allow a participant with MMSE < 23 to participate, as appropriate.
Allergy to beetroot juice
Currently consuming beetroot juice or oral nitrate or nitrite, or a beetrootsupplement, and/or unwilling to avoid these during study participation. Participantscurrently consuming one cup of beets daily will be asked to discontinue beetingestion for 30 days before baseline testing and throughout the clinical trial. Ifthe potential participant is unwilling to refrain from daily beet consumption of onecup or more, they will not be eligible for the clinical trial.
Unstable angina
Abnormal baseline stress test without subsequent clearance for exercise by physician
Non-English speaking. The SMART PAD interventions are delivered by interventionistswho do not speak non-English languages. The integrity of the clinical trial requiresclear and effective communication for data collection and intervention delivery. Thetrial does not have staff members who are fluent in non-English languages, nor doesit have the ability to translate all study materials into other languages.
Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants willbecome eligible after the final study follow-up visit of the stem cell or genetherapy study so long as at least six months have passed since the finalintervention administration. After completing a supplement or drug therapy (otherthan stem cell or gene therapy), participants will be eligible after the final studyfollow-up visit as long as at least three months have passed since the finalintervention of the trial.] Participants in a study that involved up to three singledoses of nitrate-rich beetroot juice administered on separate days may participateif a month has passed since their last dose of nitrate-rich beetroot juice.
Visual impairment that limits walking ability.
Baseline blood pressure <100/45.
Participation in a supervised treadmill exercise program or cardiac rehabilitationprogram in previous three months.
Using a mouthwash containing chlorhexidine or cetylpyridinium chloride or amouthwash determined to be bactericidal and unwilling to discontinue.
In addition to the above criteria, investigator discretion will be used to determineif the trial is unsafe or not a good fit for the potential participant.
Study Design
Study Description
Connect with a study center
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
University of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available
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