Peripheral Arterial Disease study: Home-Based Exercise
Official title SMART Exercise for PAD
ClinicalTrials.gov ID: NCT06032065
What this study is testing
- What it's testing
- This study is testing whether beetroot juice and home walking improve walking distance for people with PAD. It also looks at whether supervised treadmill exercise is better than home walking.
- Who it's for
- You may be able to join if you have peripheral artery disease that makes walking hard and you can walk at least 50 feet without stopping.
- What's involved
- You will be assigned to one of four groups. You may walk on a treadmill at a center three times a week or walk at home. You will also drink beetroot juice or a pretend drink each day. You will have check‑ins and tests to see how far you can walk.
- Time commitment
- The study lasts 12 weeks. You will have about 12 exercise sessions and several visits for tests and check‑ins.
- Phase 3: a large, late-stage study
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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...
- An ABI of \>0.90 and \<1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.
You likely can't join if
- 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
See the full eligibility criteria
- 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 angiographic evidence of PAD defined as at least 70% stenosis of an...
- An ABI of \>0.90 and \<1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.
- 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 or supervised exercise)
- Planning to engage in new walking exercise outside of the study or unwilling to refrain 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 in the 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 cancer requiring treatment in the previous two years.
- Mini-Mental Status Examination (MMSE) score \< 23 or dementia. However, if the MMSE is \< 23 and the Principal Investigator evaluation determines that the lower score is related to language barriers or education level...
- Allergy to beetroot juice
- Currently consuming beetroot juice or oral nitrate or nitrite, or a beetroot supplement, and/or unwilling to avoid these during study participation.
- Unstable angina
- Abnormal baseline stress test without subsequent clearance for exercise by physician
- Non-English speaking. The SMART PAD interventions are delivered by interventionists who do not speak non-English 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 will become eligible after the final study follow-up visit...
- Visual impairment that limits walking ability.
- Baseline blood pressure \<100/45.
- Participation in a supervised treadmill exercise program or cardiac rehabilitation program in previous three months.
- Using a mouthwash containing chlorhexidine or cetylpyridinium chloride or a mouthwash determined to be bactericidal and unwilling to discontinue.
- An eGFR value \ 5.0.
- History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial.
- In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States; Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.