Phase
Condition
Thrombosis
Peripheral Arterial Disease (Pad)
Claudication
Treatment
Nitrate-Rich Beetroot Juice + supervised exercise therapy
Attention Control
Placebo + supervised exercise therapy
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
An ABI less than or equal to 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 more than 0.90 and less than 1.00 who experience a 20% or greater drop inABI in either leg after the heel-rise test.
Exclusion
Exclusion Criteria:
Above- or below-knee amputation
Limb-threatening ischemia defined as an ABI less than 0.40 with symptoms of restpain
Wheelchair confinement or requiring a walker to ambulate
Walking is limited by a condition other than PAD
Current foot ulcer on bottom of foot
Failure to complete study-run
Unwilling to accept randomization into either group (supervised exercise orattention control)
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, usinginvestigator discretion.
End-stage kidney disease (ESKD) that is treated with hemodialysis.
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 less than 23 or dementia. If the MMSE isless than 23 and the Principal Investigator evaluation determines that the lowerscore is related to language barriers or education level, the Principal Investigatorhas discretion to allow a participant with MMSE less than 23 to participate, asappropriate. Dementia with sufficient impairment to prevent full engagement in allaspects of the trial will be an exclusion per the investigator's discretion.
Allergy to beetroot juice
Currently consuming beetroot juice, oral nitrate or nitrite, or a beetrootsupplement and/or unwilling to avoid beetroot juice during the study. Participantswill be asked to discontinue these items for 30 days before baseline testing andthroughout the clinical trial. If the potential participant is unwilling to refrainfrom taking these items, they will not be eligible for the clinical trial.
Currently consuming one cup or more of beets daily. Participants will be asked todiscontinue beet ingestion of one cup or more of beets for 30 days before baselinetesting and throughout the clinical trial. If the potential participant is unwillingto refrain from daily beet consumption of one cup or more for 30 days before thetrial and during the trial, 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 RESIST 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 less than 100/45.
Participation in a supervised treadmill exercise program in previous three months orplanning to begin a supervised treadmill exercise program in the next six months.
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 StatesSite Not Available
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