Exercise and Beetroot Juice for Peripheral Artery Disease
(RESIST Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Northwestern University
Must not be taking: Oral nitrates, Beetroot supplements
Disqualifiers: Amputation, Ischemia, Ulcer, ESKD, others
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
RESIST PAD is a randomized trial of 200 PAD patients to establish: 1) whether a 12-week exercise intervention significantly increases Δ nitrite at 12-week follow-up, compared to control; 2) whether exercise "responders" have greater Δ nitrite increases compared to "non-responders"; 3) among non-responders, whether supplementing exercise with nitrate-rich beetroot juice between weeks 13-24 increases Δ nitrite and improves 6-minute walk at 24-week follow-up.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must stop consuming beetroot juice, oral nitrate or nitrite, and beetroot supplements for 30 days before the trial and throughout the study.
What data supports the effectiveness of the treatment Nitrate-Rich Beetroot Juice + supervised exercise therapy for Peripheral Artery Disease?
Research shows that supervised exercise therapy (SET) improves walking ability in people with peripheral artery disease (PAD), and supervised treadmill-walking training enhances walking capacity and calf-muscle strength. These findings suggest that combining exercise with treatments like beetroot juice, which is known for its potential cardiovascular benefits, could be effective for PAD.12345
Is supervised exercise therapy safe for people with peripheral artery disease?
How is supervised treadmill exercise different from other treatments for peripheral artery disease?
Supervised treadmill exercise (SET) is unique because it specifically focuses on improving walking capacity and calf muscle strength through guided walking sessions, which is different from other treatments like home-based exercise or surgical options. It involves regular, structured exercise sessions under professional supervision, which can enhance endurance and quality of life for patients with peripheral artery disease.1451011
Eligibility Criteria
This trial is for individuals with Peripheral Arterial Disease (PAD), specifically those who experience intermittent claudication, which is muscle pain during exercise due to poor blood flow. Participants should be able to perform treadmill exercises and have not been involved in regular exercise programs recently.Inclusion Criteria
My ABI score drops significantly after a physical leg test.
An ABI less than or equal to 0.90 at baseline
I have been diagnosed with PAD based on vascular tests or angiography.
Exclusion Criteria
Abnormal baseline stress test without subsequent clearance for exercise by physician
I am not planning any major surgery or heart/leg artery procedures in the next 6 months.
I have a current foot ulcer on the bottom of my foot.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a 12-week supervised treadmill exercise program or attend educational sessions
12 weeks
3 visits per week (in-person) for exercise group; 1 visit per week (in-person or virtual) for control group
Supplementation
Non-responders receive an additional 12 weeks of exercise with either nitrate-rich or placebo beetroot juice
12 weeks
3 visits per week (in-person)
Follow-up
Participants are monitored for changes in six-minute walk distance and other biomarkers
12 weeks
Treatment Details
Interventions
- Nitrate-Rich Beetroot Juice + supervised exercise therapy (Combination Product)
- Placebo + supervised exercise therapy (Combination Product)
- Supervised Treadmill Exercise (Behavioral Intervention)
Trial OverviewThe RESIST PAD study tests if a 12-week supervised treadmill exercise program can increase nitric oxide levels compared to a control group. It also examines if adding nitrate-rich beetroot juice enhances benefits for those who don't initially respond well to the exercise alone.
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Supervised Treadmill ExerciseExperimental Treatment1 Intervention
This group will be participating in supervised treadmill exercise for 12 weeks. Participants will walk for exercise on a treadmill 3 times per week at a center while supervised by healthcare personnel.
Group II: Exercise Supplementation with Nitrate-Rich Beetroot JuiceExperimental Treatment1 Intervention
This group for "non-responders" will receive supervised exercise supplementation with nitrate-rich beetroot juice for an additional 12 weeks.
Group III: Exercise Supplementation with Placebo Beetroot JuicePlacebo Group1 Intervention
This group for "non-responders" will received supervised exercise supplementation with placebo beetroot juice for the additional 12 weeks.
Group IV: Attention Control GroupPlacebo Group1 Intervention
This group will attend weekly one-hour educational sessions either on Zoom or in-person for 12 weeks. These sessions are on topics of interest to the typical PAD patient and may be led by study staff, physicians, or other health care workers.
Supervised Treadmill Exercise is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Supervised Exercise Therapy (SET) for:
- Lower Extremity Peripheral Artery Disease (PAD)
🇪🇺 Approved in European Union as Supervised Exercise Therapy (SET) for:
- Lower Extremity Peripheral Artery Disease (PAD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern University Feinberg School of MedicineChicago, IL
University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Effects of supervised exercise therapy on blood pressure and heart rate during exercise, and associations with improved walking performance in peripheral artery disease: Results of a randomized clinical trial. [2021]Supervised exercise therapy (SET) improves walking ability in people with peripheral artery disease (PAD). However, the effects of SET on cardiovascular health in PAD remain unclear. Using data from a randomized clinical trial, this post hoc analyses investigated the effects of a 6-month SET intervention, compared with a control group, on changes in blood pressure (BP) and heart rate (HR) during a graded treadmill exercise test in people with PAD.
Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. [2018]The effectiveness of supervised exercise programs (SEPs) for the management of peripheral arterial disease (PAD) can be hampered by low accessibility and poor compliance. The current international availability and use of SEPs was evaluated and the evidence on alternative approaches such as structured, home-based exercise programs (HEPs) was reviewed. METHODS-MATERIALS: International survey on SEP availability among vascular surgeons using an online questionnaire. A systematic review on structured-HEPs effectiveness was also performed.
The Group Oriented Arterial Leg Study (GOALS) to improve walking performance in patients with peripheral arterial disease. [2021]People with lower extremity peripheral artery disease (PAD) have greater functional impairment and faster functional decline than those without PAD. We describe methods for the Group Oriented Arterial Leg Study (GOALS), an ongoing randomized controlled clinical trial designed to determine whether a Group-Mediated Cognitive Behavioral (GMCB) intervention improves functional performance in PAD participants, compared to a health education control condition. In GOALS, PAD participants were randomized to either an intervention or a health education control condition in a parallel design. Both conditions consist of weekly group sessions with other PAD participants. In the intervention, cognitive behavioral techniques are used to assist participants in setting and adhering to home-based walking exercise goals. Participants are encouraged to walk for exercise at home at least 5 days/week. In the control condition, participants receive lectures on health-related topics. After 6 months of on-site weekly sessions, participants are transitioned to telephone follow-up for another 6 months. Participants in the intervention are asked to continue home walking exercise. The primary outcome is change in six-minute walk performance between baseline and six-month follow-up. Secondary outcomes include change in six-minute walk performance at 12-month follow-up, and change in treadmill walking performance, the Walking Impairment Questionnaire, quality of life, and physical activity at six and 12-month follow-up. In conclusion, if our group-mediated cognitive behavioral intervention is associated with improved walking performance in individuals with PAD, results will have major public health implications for the large and growing number of people with PAD.
PoleStriding exercise and vitamin E for management of peripheral vascular disease. [2022]The purpose of this investigation was to evaluate the efficacy of PoleStriding exercise (a form of walking that uses muscles of the upper and lower body in a continuous movement similar to cross-country skiing) and vitamin E (alpha-tocopherol) to improve walking ability and perceived quality of life (QOL) of patients with claudication pain secondary to peripheral arterial disease (PAD).
Effects of supervised treadmill-walking training on strength and endurance of the calf muscles of individuals with peripheral arterial disease. [2006]Supervised treadmill-walking training is an effective treatment to improve walking capacity for individuals with peripheral arterial disease (PAD). The primary aim of this study was to examine whether a supervised treadmill-walking program would improve calf-muscle strength and endurance in individuals with PAD.
Claudicating patients with peripheral artery disease have meaningful improvement in walking speed after supervised exercise therapy. [2022]Supervised exercise therapy (SET) is a first-line treatment for patients with peripheral artery disease (PAD). The efficacy of SET is most commonly expressed by significant statistical improvement of parameters that do not clarify how each individual patient will benefit from SET. This study examined the minimal clinically important difference (MCID) in walking speed in claudicating patients with PAD after SET.
Experience Implementing Supervised Exercise Therapy for Peripheral Artery Disease. [2022]Supervised exercise therapy (SET) is a cornerstone of treatment for improving walking distance for individuals with symptomatic peripheral artery disease and claudication. High quality randomized controlled trials have documented the efficacy of SET as a claudication treatment and led to the recent Centers for Medicare and Medicaid decision to cover supervised exercise therapy (SET). However, to date, the translation of highly controlled, laboratory based SET programs in real world cardiopulmonary rehabilitation settings has been unexplored.
Safety of supervised exercise therapy in patients with intermittent claudication. [2022]Supervised exercise therapy (SET) is recommended as the primary treatment for patients with intermittent claudication (IC). However, there is concern regarding the safety of performing SET because IC patients are at risk for untoward cardiovascular events. The Dutch physical therapy guideline advocates cardiac exercise testing before SET, if indicated. Perceived uncertainties concerning safety may contribute to the underuse of SET in daily practice. The objective of this review was to analyze the safety of supervised exercise training in patients with IC.
When is supervised exercise therapy considered useful in peripheral arterial occlusive disease? A nationwide survey among vascular surgeons. [2018]Although international guidelines state that supervised exercise therapy (SET) should be offered to all patients with intermittent claudication (IC), SET appears to be underutilised in clinical practice. The aim of this study was to document current opinions of Dutch vascular surgeons on SET as treatment option for peripheral arterial occlusive disease (PAOD).
Implementation of a supervised exercise therapy programme. [2020]Guidelines for peripheral vascular disease state that supervised exercise therapy (SET) programmes improve walking distance and quality of life in patients with intermittent claudication. This paper outlines the steps needed to implement a successful SET programme and discusses some of the challenges.
The Effect of Supervised Exercise, Home Based Exercise and Endovascular Revascularisation on Physical Activity in Patients With Intermittent Claudication: A Network Meta-analysis. [2020]It is unclear whether supervised exercise therapy (SET), home based exercise therapy (HBET), and endovascular revascularisation (ER) for intermittent claudication (IC) have a meaningful impact on physical activity, despite extensive research on their effect on walking performance.