LEAP Therapy for Peripheral Artery Disease

Overseen By Song-Young Park, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Kidney disease, Type II diabetes, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the effects of leg exercise assistive paddling (LEAP) therapy during prolonged sitting (PS) on vascular and functional performance in those with peripheral artery disease (PAD) and age-matched controls. LEAP therapy is a novel application of passive limb movement to enhance blood flow through the legs without muscular contractions. Specifically, LEAP therapy is the rotational passive movement of the lower leg about the knee from 90 to 180 degrees of rotation at a cadence of 1Hz. Previous literature has indicated that this movement pattern can produce robust increases in blood flow in the passively moved limb in healthy individuals, and passive limb movement may protect vascular function during PS. However, the impact of LEAP therapy to improve blood flow in the legs of those with PAD during PS is unknown. Participants will participate in a randomized cross-over design study with 2 visits (LEAP therapy and no LEAP therapy). For the first visit, participants will be randomly allocated to receive LEAP therapy during 2.5 hours of PS or not. For the second visit, participants will sit for 2.5 hours and will receive the condition that they did not previously receive. Before and after PS, the following measurements will be made: flow-mediated dilation of the popliteal and brachial arteries, arterial stiffness with tonometry techniques, microvascular vasodilatory capacity and skeletal muscle metabolic rate with near-infrared spectroscopy, autonomic nervous system function, and there will be blood drawn from the antecubital vein. After PS, participants will participate in a graded exercise test to assess functional walking capacity. Finally, during PS, near-infrared spectroscopy on the calf muscles and electrocardiogram will be collected continuously to monitor muscle oxygen availability and autonomic activity, respectively.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study coordinators or your doctor.

What data supports the effectiveness of the treatment LEAP Therapy for Peripheral Artery Disease?

Research shows that exercise therapy, like supervised walking, helps people with peripheral artery disease (PAD) walk longer distances, similar to surgical treatments. This suggests that exercise-based treatments, such as LEAP Therapy, could be effective for improving walking ability in PAD patients. ^{1 2 3 4 5}

Is LEAP Therapy safe for humans?

There is no specific safety data available for LEAP Therapy, but a similar home-based leg heat therapy was found to be safe and well-tolerated in patients with peripheral artery disease. ^{1 2 6 7 8}

How is LEAP Therapy different from other treatments for peripheral artery disease?

LEAP Therapy is unique because it involves Leg Exercise Assistive Paddling, which may offer a novel approach to improving walking ability in patients with peripheral artery disease, unlike traditional treatments like supervised walking exercise or surgical interventions. ^{1 6 9 10 11}

Research Team

Song-Young Park, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for individuals aged 50-85 with peripheral artery disease (PAD), specifically those who experience exercise-limiting claudication and have an ankle brachial index (ABI) ≤0.9. Women must be postmenopausal to participate. The study aims to include both PAD patients and age-matched controls.

Inclusion Criteria

I do not have ulcers or dead tissue on my foot due to poor blood flow.

I am a postmenopausal woman (no periods for over 24 months).

PAD subjects must be able to provide written informed consent

Exclusion Criteria

My doctor noted exercise limitations at my last check-up within a year.

I have difficulty walking due to a musculoskeletal injury.

My walking is limited due to reasons other than PAD.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two sessions of prolonged sitting with and without LEAP therapy, each lasting 2.5 hours, with a minimum 7-day washout period between sessions.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LEAP Therapy

Trial Overview The LEAP therapy, which involves passive leg movements to boost blood flow without muscle contractions, is being tested against no therapy during prolonged sitting sessions of 2.5 hours. Participants will undergo two sessions in a randomized order: one with LEAP therapy and one without.

Participant Groups

Group I: PAD: No LEAP therapy, then LEAP therapy Experimental Treatment 2 Interventions

Participants with peripheral artery disease will perform a bout of 2.5 hours of prolonged sitting without LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting with LEAP therapy.

Group II: PAD: LEAP therapy, then no LEAP therapy Experimental Treatment 2 Interventions

Participants with peripheral artery disease will perform a bout of 2.5 hours of prolonged sitting with LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting without LEAP therapy.

Group III: Control: No LEAP therapy, then LEAP therapy Experimental Treatment 2 Interventions

Participants will perform a bout of 2.5 hours of prolonged sitting without LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting with LEAP therapy.

Group IV: Control: LEAP therapy, then no LEAP therapy Experimental Treatment 2 Interventions

Participants will perform a bout of 2.5 hours of prolonged sitting with LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting without LEAP therapy.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Findings from Research

In a study of 47 patients with peripheral artery disease (PAD), six months of supervised exercise therapy significantly improved walking distances, quality of life, and maximal plantar flexor strength, despite no significant change in the ankle-brachial index (ABI).

The therapy also enhanced gait biomechanics, particularly in torque and power generation at the ankle and hip, indicating that supervised exercise can effectively improve mobility and function in claudicating patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised walking exercise therapy improves gait biomechanics in patients with peripheral artery disease. Schieber, MN., Pipinos, II., Johanning, JM., et al.[2021]

This study aims to evaluate how patient education interventions can enhance physical activity (PA) capacity and behavior in individuals with peripheral arterial disease (PAD) and intermittent claudication (IC), which are conditions that limit physical activity.

The review will analyze both quantitative and qualitative data from various databases, focusing on changes in PA capacity and adherence to PA improvements, using rigorous methods to ensure the quality and reliability of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education interventions to improve physical activity in patients with intermittent claudication: a protocol for a systematic mixed-studies review. Abaraogu, UO., Dall, PM., Seenan, CA.[2022]

A systematic review of 24 randomized controlled trials involving 924 participants with peripheral arterial disease (PAD) found that structured exercise, particularly aerobic training and progressive resistance training, significantly improved aerobic capacity and muscle strength, with muscle strength showing a strong correlation to improved walking ability.

While improvements in walking distance were noted, particularly in initial claudication distance, the relationship between exercise and performance-based tests of daily function remains unclear, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise on fitness and performance-based tests of function in intermittent claudication: a systematic review. Parmenter, BJ., Raymond, J., Fiatarone Singh, MA.[2022]

In a 3-month pilot study involving 29 participants with peripheral artery disease (PAD), motivational interviewing (MI) significantly increased walking distance and led to greater weight loss compared to a smartphone app intervention.

Participants in the MI group experienced an average increase of 40.5 meters in walking distance and a weight loss of 10.1 lbs, while the app group showed only a small weight loss and no significant increase in walking distance, highlighting the potential effectiveness of MI for improving outcomes in overweight/obese adults with PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Smartphone App Versus Motivational Interviewing to Increase Walking Distance and Weight Loss in Overweight/Obese Adults With Peripheral Artery Disease: Pilot Randomized Trial. Collins, T., Geana, M., Overton, K., et al.[2023]

Supervised treadmill exercise significantly improves walking performance in patients with lower extremity peripheral artery disease (PAD), with a meta-analysis showing an average increase of 180 meters in maximal walking distance and 128 meters in pain-free walking distance compared to control groups.

Home-based walking exercise programs that include behavioral change techniques are also effective, improving walking ability even more than supervised treadmill exercise, providing a viable alternative for patients who cannot attend regular supervised sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Rehabilitation for Peripheral Artery Disease: A REVIEW. McDermott, MM.[2019]

In a study of 305 participants with peripheral artery disease (PAD), high-intensity home-based walking exercise significantly improved walking ability compared to low-intensity exercise and a nonexercise control, with a mean increase of 34.5 meters in the 6-minute walk distance after 12 months (P < 0.001).

Low-intensity home-based walking exercise did not show a significant improvement in walking distance compared to the nonexercise control group, indicating that it may not be an effective intervention for enhancing walking performance in PAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial. McDermott, MM., Spring, B., Tian, L., et al.[2022]

A pilot study involving 34 patients with symptomatic peripheral artery disease (PAD) found that unsupervised, home-based leg heat therapy significantly improved walking performance, with a notable increase in the 6-minute walk distance after 8 weeks compared to a sham treatment.

The leg heat therapy was shown to be safe and well-tolerated, suggesting it could be a practical and painless adjunctive treatment to enhance physical function in patients with PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home-based leg heat therapy on walking performance in patients with symptomatic peripheral artery disease: a pilot randomized trial. Monroe, JC., Pae, BJ., Kargl, C., et al.[2023]

A pilot study involving 40 patients with peripheral arterial disease (PAD) showed that a comprehensive lifestyle intervention, which included education and weekly counseling, resulted in better quality of life scores compared to standard care, with VascuQoL-6 scores of 17.4 versus 13.8.

Despite challenges, such as low attendance in supervised exercise therapy, the intervention demonstrated high adherence to medication and some positive changes in weight and smoking habits, indicating potential benefits of a multi-faceted approach to best medical therapies in PAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best medical treatment in patients with PAD. Rosenberg, Y., Behrendt, CA.[2023]

In a study of 42 diabetic patients with critical limb ischemia who underwent percutaneous transluminal balloon angioplasty (PTA), the 3-year limb salvage rate was 66%, indicating that while PTA is effective, long-term outcomes may vary.

The study found that 90% of patients achieved technical success with PTA, but the 3-year limb salvage rates were lower in this Asian diabetic population compared to Western populations, highlighting the need for tailored approaches in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical limb ischaemia in a diabetic population from an Asian Centre: angiographic pattern of disease and 3-year limb salvage rate with percutaneous angioplasty as first line of treatment. Tan, M., Pua, U., Wong, DE., et al.[2021]

In a study of 46 patients with critical limb ischaemia who underwent percutaneous transluminal balloon angioplasty (PTA), the procedure achieved a high technical success rate of 89% and significantly improved blood flow, as indicated by an increase in the mean ankle-brachial index (ABI) from 0.62 to 0.91 immediately after the procedure.

The 1-year limb salvage rates were impressive, with 78% of patients retaining their limbs, and significant clinical improvements were observed, including symptom relief in 91% of patients with rest pain and healing in 66% of those with gangrene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Angioplasty in critical limb ischaemia: one-year limb salvage results. Pua, U., Wong, DE.[2020]

Patients with peripheral artery disease reported positive experiences with the ankle-foot orthosis (AFO) in terms of usability and cost-effectiveness, indicating that the device was easy to use and had no out-of-pocket costs during the 3-month intervention.

Despite initial positive feedback, challenges related to motivation and the AFO's impact on daily activities led to lower compliance after the intervention, highlighting the need to address patients' perceptions to improve long-term use and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term use of an ankle-foot orthosis intervention in patients with peripheral artery disease using the integrated promoting action on research implementation in health services (i-PARIHS) framework. Bashir, AZ., Dinkel, DM., Pipinos, II., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Supervised walking exercise therapy improves gait biomechanics in patients with peripheral artery disease. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Patient education interventions to improve physical activity in patients with intermittent claudication: a protocol for a systematic mixed-studies review. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

The effect of exercise on fitness and performance-based tests of function in intermittent claudication: a systematic review. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Use of a Smartphone App Versus Motivational Interviewing to Increase Walking Distance and Weight Loss in Overweight/Obese Adults With Peripheral Artery Disease: Pilot Randomized Trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Exercise Rehabilitation for Peripheral Artery Disease: A REVIEW. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of home-based leg heat therapy on walking performance in patients with symptomatic peripheral artery disease: a pilot randomized trial. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Best medical treatment in patients with PAD. [2023]

9. Malaysia pubmed.ncbi.nlm.nih.gov

Critical limb ischaemia in a diabetic population from an Asian Centre: angiographic pattern of disease and 3-year limb salvage rate with percutaneous angioplasty as first line of treatment. [2021]

10. Singapore pubmed.ncbi.nlm.nih.gov

Angioplasty in critical limb ischaemia: one-year limb salvage results. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term use of an ankle-foot orthosis intervention in patients with peripheral artery disease using the integrated promoting action on research implementation in health services (i-PARIHS) framework. [2023]