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Exercise and Beetroot Juice for Peripheral Arterial Disease (IMPACT PAD Trial)
Phase 3
Waitlist Available
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Successful revascularization adjudicated by committee and defined as considered successful based on the surgical note and subsequent clinical visits
Be older than 18 years old
Must not have
Major medical illness including lung disease requiring oxygen, Parkinson's disease, or a life-threatening illness with life expectancy less than six months
Visual impairment that limits walking ability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 month follow-up
Awards & highlights
Pivotal Trial
Summary
This trial aims to see if combining home-based exercise with lower extremity revascularization can improve walking performance more than just revascularization alone in patients with peripheral artery disease (PAD). Additionally, it
Who is the study for?
This trial is for patients with Peripheral Artery Disease (PAD) who have undergone revascularization but still experience walking difficulties. Participants should be within three months post-successful revascularization and willing to follow a home-based exercise program or consume beetroot juice.
What is being tested?
The study tests if home-based exercises or nitrate-rich beetroot juice can improve walking performance after leg artery surgery, compared to usual care alone. It's a randomized trial where participants are assigned by chance to one of four groups: exercise, placebo juice, nitrate juice, or attention control.
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort from the beetroot juice. The home-based exercise could lead to muscle soreness or injury if not performed correctly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My surgery to improve blood flow was successful.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a severe illness like lung disease needing oxygen, Parkinson's, or a terminal illness with less than 6 months to live.
Select...
My vision problems make it hard for me to walk.
Select...
I cannot communicate in English.
Select...
I have had severe blockages in my leg arteries causing pain and sores.
Select...
I am currently taking medication for erectile dysfunction.
Select...
I have had a leg amputation, but not just a toe or part of my foot.
Select...
I use a wheelchair or walker to move around.
Select...
My walking is limited due to a condition that is not peripheral artery disease.
Select...
I have a current foot ulcer on the bottom of my foot.
Select...
I have unstable chest pain.
Select...
I am scheduled for major surgery within the next six months.
Select...
I have had gangrene in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to six-month follow-up at the time point that is twenty-four hours after nitrate rich beetroot juice
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to six-month follow-up at the time point that is twenty-four hours after nitrate rich beetroot juice
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Six-Minute Walk Distance 6-month change
Six-Minute Walk Distance at baseline
Secondary study objectives
PROMIS Mobility Questionnaire Score 12-month change
PROMIS Mobility Questionnaire Score 6-month change
Prevention of Hemodynamic Failure of The Revascularized Vessel
+2 moreOther study objectives
BH2 6-month change
BH4 6-month change
BH4/BH2 6-month change
+3 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Home based exercise + nitrate rich beetroot juiceExperimental Treatment2 Interventions
This group will be participating in home based exercise and drinking nitrate rich beetroot juice for six months.
Group II: Attention control + nitrate-rich beetroot juiceExperimental Treatment2 Interventions
This group will be participating in attention control and drinking nitrate rich beetroot juice for six months.
Group III: Home-based exercise + placeboPlacebo Group2 Interventions
This group will be participating in home based exercise and drinking placebo beetroot juice with nitrate removed for six months.
Group IV: Attention control + placeboPlacebo Group2 Interventions
This group will be participating in attention control and drinking placebo beetroot juice with nitrate removed for six months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitrate Rich Beetroot Juice
2015
N/A
~30
Home Based Exercise
2016
Completed Phase 3
~40
Attention Control
2014
Completed Phase 2
~6520
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,649 Previous Clinical Trials
958,385 Total Patients Enrolled
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