~133 spots leftby Oct 2030

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?

Supervised exercise therapy (SET) is generally considered safe for people with peripheral artery disease, although there are concerns about cardiovascular risks. Guidelines recommend cardiac exercise testing before starting SET to ensure safety.16789

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

Research Team

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.
See 22 more

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+
Dr. Jeffrey Sherman profile image

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler profile image

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

In a study of 210 participants with peripheral artery disease (PAD), a 6-month supervised exercise therapy (SET) program significantly reduced systolic blood pressure by 12 mm Hg, pulse pressure by 9 mm Hg, and heart rate by 7 beats per minute during exercise compared to a control group.
The improvements in cardiovascular health metrics (blood pressure and heart rate) were associated with better walking performance, indicating that SET not only enhances walking ability but also positively impacts cardiovascular health in individuals with PAD.
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.Slysz, JT., Tian, L., Zhao, L., et al.[2021]
Only 30.4% of vascular surgeons reported access to supervised exercise programs (SEPs) for managing peripheral arterial disease (PAD), highlighting a significant accessibility issue.
Structured home-based exercise programs (HEPs) were found to be effective alternatives, significantly improving functional capacity and quality of life compared to standard advice, although SEPs were superior in some cases.
Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease.Makris, GC., Lattimer, CR., Lavida, A., et al.[2018]
PoleStriding exercise significantly improved exercise tolerance and reduced claudication pain in patients with peripheral arterial disease (PAD), as shown by a randomized trial with 52 participants.
Vitamin E supplementation did not provide any additional benefits in terms of pain relief or exercise capacity compared to the PoleStriding exercise alone.
PoleStriding exercise and vitamin E for management of peripheral vascular disease.Collins, EG., Edwin Langbein, W., Orebaugh, C., et al.[2022]

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]
Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. [2018]
The Group Oriented Arterial Leg Study (GOALS) to improve walking performance in patients with peripheral arterial disease. [2021]
PoleStriding exercise and vitamin E for management of peripheral vascular disease. [2022]
Effects of supervised treadmill-walking training on strength and endurance of the calf muscles of individuals with peripheral arterial disease. [2006]
Claudicating patients with peripheral artery disease have meaningful improvement in walking speed after supervised exercise therapy. [2022]
Experience Implementing Supervised Exercise Therapy for Peripheral Artery Disease. [2022]
Safety of supervised exercise therapy in patients with intermittent claudication. [2022]
When is supervised exercise therapy considered useful in peripheral arterial occlusive disease? A nationwide survey among vascular surgeons. [2018]
Implementation of a supervised exercise therapy programme. [2020]
The Effect of Supervised Exercise, Home Based Exercise and Endovascular Revascularisation on Physical Activity in Patients With Intermittent Claudication: A Network Meta-analysis. [2020]