Diet and Exercise for Peripheral Artery Disease

Recruiting at 1 trial location

Overseen By Andrew Gardner, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must not be taking: Cilostazol, Pentoxifylline

Disqualifiers: Active cancer, End stage renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of combining the DASH diet with a home-based exercise plan for individuals with peripheral artery disease (PAD). The goal is to determine if this combination can enhance walking ability and blood flow. Participants will either follow the exercise plan alone or both the diet and exercise. Individuals who have experienced claudication (leg pain while walking) and have PAD may be suitable candidates. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance PAD management strategies.

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 cannot participate if you started taking cilostazol or pentoxifylline for intermittent claudication within the last three months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the DASH diet and home-based exercise programs are generally safe for most people, including those with peripheral artery disease (PAD). The DASH diet, which promotes eating more fruits, vegetables, and whole grains, is linked to a lower risk of heart problems and is well-tolerated by most individuals.

Researchers have tested home-based exercise programs in people with PAD, demonstrating that these programs help participants walk farther and faster without causing major issues. These exercises are considered safe and effective for many with PAD.

Both components of the trial treatment are supported by evidence showing they are safe and can positively impact health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for Peripheral Artery Disease (PAD) because they focus on lifestyle changes rather than medications or surgical interventions, which are often the standard approaches. The DASH Diet plus Home-Based Exercise uniquely combines dietary changes with exercise, emphasizing fruits, vegetables, whole grains, and low-fat dairy to improve overall cardiovascular health. The Home-Based Exercise program offers flexibility, allowing patients to manage their condition through regular, moderate-intensity walking in the comfort of their own homes. These approaches aim to empower patients to take control of their health with potentially fewer side effects and a more sustainable long-term impact.

What evidence suggests that this trial's treatments could be effective for PAD?

Research has shown that both the DASH diet and home exercise can help treat Peripheral Artery Disease (PAD). In this trial, one group of participants will follow the DASH diet, which includes plenty of fruits, vegetables, whole grains, and low-fat dairy, and is linked to better heart health. When combined with exercise, this diet can enhance exercise capacity and quality of life for people with PAD. Another group in the trial will focus on a home-based exercise program. Home walking programs have been found to significantly increase the distance and speed at which people with PAD can walk. Regular exercise is often recommended to improve walking ability and overall fitness in people with PAD. ^{1 2 3 4 6}

Who Is on the Research Team?

Andrew Gardner, Ph.D.

Principal Investigator

Professor, Department of Medicine, Cardiology

Are You a Good Fit for This Trial?

This trial is for individuals with Peripheral Artery Disease (PAD), specifically those who have leg pain during walking, and have either abnormal ankle-brachial index (ABI) readings or a history of procedures to improve blood flow. It's not for people without PAD, those with severe PAD symptoms like rest pain or tissue loss, recent revascularization, active cancer, certain chronic conditions, cognitive dysfunction, or on recent claudication medication.

Inclusion Criteria

I have peripheral artery disease (PAD) confirmed by a test or past treatment.

I have poor circulation in my legs, confirmed by a test or previous surgery.

I have experienced leg pain from walking.

Exclusion Criteria

I started taking medication for leg pain when walking in the last 3 months.

You have medical conditions that make it unsafe for you to exercise, as determined by the American College of Sports Medicine.

I have severe tissue loss due to poor blood flow in my legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a combined DASH dietary program and home-based exercise program, or a home-based exercise program alone, for 3 months

12 weeks

Weekly self-reported monitoring

Follow-up

Participants are monitored for changes in exercise and vascular outcomes after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DASH Diet plus Home-Based Exercise
• Home-Based Exercise

Trial Overview The study tests if a specific diet called the DASH Diet combined with home-based exercise improves physical function in PAD patients. Participants are randomly assigned to follow this regimen or just the exercise program for three months while their steps and vascular health are monitored.

How Is the Trial Designed?

Group I: DASH Diet plus Home-Based Exercise Experimental Treatment 1 Intervention

The DASH dietary program consists of a diet emphasizing foods rich in fruits, vegetables, whole grains, and low-fat dairy, in which patients record daily servings of fruits and vegetables. The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.

Group II: Home-Based Exercise Active Control 1 Intervention

The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.

DASH Diet plus Home-Based Exercise is already approved in United States for the following indications:

Approved in United States as DASH Dietary Program for:

• Peripheral Artery Disease (PAD)

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Milton S. Hershey Medical Center

Collaborator

Trials

515

Recruited

2,873,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Published Research Related to This Trial

Exercise therapy significantly improves ambulatory outcomes and reduces leg symptoms in patients with peripheral artery disease (PAD), enhancing their functional independence and quality of life.

The review emphasizes the importance of detailed exercise prescriptions in future trials to better quantify the total exercise dose, which could lead to more effective treatment strategies for PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise rehabilitation for peripheral artery disease: An exercise physiology perspective with special emphasis on the emerging trend of home-based exercise. Gardner, AW.[2022]

A home-based walking exercise intervention led by physical therapists significantly improved the 6-minute walking distance in adults with peripheral artery disease (PAD) after 3 months, with an average increase of 16.7 meters compared to usual care.

Despite 13 serious adverse events reported in the intervention group, all were deemed unrelated to the study, indicating that the intervention was safe for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Home-Based, Walking Exercise Behavior Change Intervention vs Usual Care on Walking in Adults With Peripheral Artery Disease: The MOSAIC Randomized Clinical Trial. Bearne, LM., Volkmer, B., Peacock, J., et al.[2022]

Home-based cardiac rehabilitation, using a nurse-facilitated self-help package over 6 weeks, was found to be slightly less expensive than traditional hospital-based rehabilitation, primarily due to lower personnel costs.

Both home-based and hospital-based rehabilitation showed similar overall healthcare costs and quality of life outcomes over 9 months, indicating that home-based programs can be a cost-effective alternative without compromising patient health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based cardiac rehabilitation versus hospital-based rehabilitation: a cost effectiveness analysis. Taylor, RS., Watt, A., Dalal, HM., et al.[2022]

In a study of 27 overweight older adults, those who combined a weight loss diet (DASH) with moderate intensity resistance training (DASH-RT) experienced significantly greater reductions in body fat and increases in lean muscle mass compared to those on the diet alone.

While both groups lost weight and improved their walking times, the DASH-RT group showed enhanced strength and better thigh composition, suggesting that resistance training can provide additional benefits beyond just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of moderate intensity resistance training during weight loss on body composition and physical performance in overweight older adults. Avila, JJ., Gutierres, JA., Sheehy, ME., et al.[2022]

A home-based cardiac rehabilitation program enhances access and enrollment for patients, making it easier for them to participate in their recovery.

This program utilizes an evidence-based alternative model of care, which suggests it is grounded in proven methods for improving heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Design and Implementation of a Home-Based Cardiac Rehabilitation Program. Rohrbach, G., Schopfer, DW., Krishnamurthi, N., et al.[2020]

The Ti-To program, which involved structured home-based walking sessions and monthly check-ups, significantly improved perceived claudication and functional parameters in patients with peripheral arterial disease (PAD) compared to the traditional free walking exercise program.

Patients in the Ti-To group experienced better hemodynamic improvements, including lower resting heart rates and better ankle-brachial index scores, indicating enhanced cardiovascular health alongside improved walking ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training rather than walking: the test in -train out program for home-based rehabilitation in peripheral arteriopathy. Manfredini, F., Malagoni, AM., Mascoli, F., et al.[2019]

Home-based exercise programs (HBEPs) for individuals with intermittent claudication (IC) are safe, with only four adverse events reported over 147,810 patient-hours, resulting in a complication rate of one event per 36,953 patient-hours.

Most adverse events were cardiac-related and occurred during high levels of claudication pain, suggesting that while HBEPs are generally safe, monitoring and possibly cardiac screening may be beneficial for those engaging in more intense exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of home-based exercise for people with intermittent claudication: A systematic review. Waddell, A., Seed, S., Broom, DR., et al.[2022]

A home-based exercise intervention using a wearable activity monitor and telephone coaching did not significantly improve walking performance in patients with peripheral artery disease (PAD) over 9 months compared to usual care.

The intervention group experienced a worsening in pain interference scores, indicating that the home-based approach may not be beneficial and could potentially lead to increased discomfort for patients with PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Home-Based Exercise Intervention of Wearable Technology and Telephone Coaching on Walking Performance in Peripheral Artery Disease: The HONOR Randomized Clinical Trial. McDermott, MM., Spring, B., Berger, JS., et al.[2018]

In a study of 27 overweight and obese older adults, adding resistance training (RT) to dietary education (DE) significantly improved coronary heart disease (CHD) risk factors, including lower apoB concentrations and better DASH Diet Index scores compared to DE alone.

The DERT group showed notable improvements in body composition and blood pressure, indicating that combining RT with dietary education is more effective for enhancing health outcomes in older adults at risk for CHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the addition of resistance training to a dietary education intervention on apolipoproteins and diet quality in overweight and obese older adults. Valente, EA., Sheehy, ME., Avila, JJ., et al.[2021]

A randomized controlled trial involving 194 patients with peripheral artery disease (PAD) showed that a home-based walking exercise program significantly improved walking endurance, with participants increasing their 6-minute walk distance by an average of 53.5 meters compared to a control group.

The intervention also led to improvements in treadmill walking time, overall physical activity, and patient-reported walking ability, suggesting that this program can be an effective alternative for patients with PAD who cannot attend supervised exercise sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based walking exercise intervention in peripheral artery disease: a randomized clinical trial. McDermott, MM., Liu, K., Guralnik, JM., et al.[2022]

In a study of 20 patients with peripheral artery disease (PAD) participating in a 12-week community-based structured exercise training program, non-exercise walking (NEW) activity was found to have a moderate positive correlation with improvements in peak walking time (PWT), suggesting that everyday walking can enhance exercise performance.

The results indicate that increasing walking activity outside of formal exercise sessions may be beneficial for PAD patients, highlighting the importance of overall physical activity in managing their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of non-exercise walking activity with exercise performance in patients with peripheral artery disease: NEW activity for PAD. Mays, RJ., Kahnke, R., Schorr, EN., et al.[2023]

The SPRINT exercise program was implemented with 19 out of 50 older patients in a Geriatric Assessment Unit, showing that it is feasible to integrate such a program into hospital settings.

Most patients engaged in an average of one exercise session per day, primarily with healthcare professionals, indicating a positive initial adherence to the program, though caregiver involvement was minimal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Implementing an Exercise Program in a Geriatric Assessment Unit: the SPRINT Program. Juneau, A., Bolduc, A., Nguyen, P., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03845036

The Effects of Diet and Exercise Interventions in Peripheral ... This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a ...

2. reporter.nih.gov reporter.nih.gov/project-details/11109455

The Effects of Diet and Exercise Interventions in Peripheral ... We propose to test the efficacy of a modDASH dietary program combined with an exercise program (modDASH+Ex) to improve exercise and vascular outcome measures in ...

3. withpower.com withpower.com/trial/phase-peripheral-arterial-disease-11-2021-a1d55

Diet and Exercise for Peripheral Artery Disease Trial Overview The study tests if a specific diet called the DASH Diet combined with home-based exercise improves physical function in PAD patients.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6413235/

DASH Dietary Pattern and Cardiometabolic Outcomes Conclusions: Current evidence allows for the conclusion that the DASH dietary pattern is associated with decreased incidence of cardiovascular disease and ...

5. pure.psu.edu pure.psu.edu/en/projects/the-effects-of-diet-and-exercise-interventions-in-peripheral-arte

The Effects of Diet and Exercise Interventions in Peripheral ... Our central hypothesis is that the modDASH+Ex program improves the efficacy to rehabilitate PAD patients by improving exercise outcomes, health-related quality ...

6. researchgate.net researchgate.net/publication/273857757_Effects_of_the_DASH_Diet_Alone_and_in_Combination_With_Exercise_and_Weight_Loss_on_Blood_Pressure_and_Cardiovascular_Biomarkers_in_Men_and_Women_With_High_Blood_Pressure_The_ENCORE_Study

Effects of the DASH Diet Alone and in Combination With ... Effects of the DASH Diet Alone and in Combination With Exercise and Weight Loss on Blood Pressure and Cardiovascular Biomarkers in Men and Women ...