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LEAP Therapy for Peripheral Artery Disease

This study is investigating a new approach called Leg Exercise Assistive Paddling (LEAP) therapy for people with Peripheral Artery Disease (PAD), also known as Peripheral Vascular Disease or Peripheral Artery Occlusive Disease. PAD is a condition where plaque builds up in the leg arteries. LEAP therapy involves gentle, passive leg movements while you are sitting for a long time, aiming to improve blood flow without requiring muscle contractions. Researchers want to see if this therapy can improve how well your blood vessels work (macrovascular endothelial function and microvascular vasodilatory capacity) and increase blood flow in your leg arteries (femoral and popliteal artery blood flow). You may be eligible if you are between 55 and 85 years old, have been diagnosed with PAD (Fontaine stage II-III), experience leg pain with exercise (claudication), and do not have ulcers or gangrene. The study is also looking for age-matched control subjects.

Study design
This interventional study plans to enroll 24 participants. It compares LEAP therapy to no LEAP therapy during prolonged sitting.
What's involved
Participants will undergo assessments before and after the conditions on Day 1 and Day 7. This involves either 2.5 hours of prolonged sitting with LEAP therapy or 2.5 hours of uninterrupted sitting.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 7 days, with measurements taken before and after the conditions on Day 1 and Day 7.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06389149

Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease

Withdrawn
NAAges 55–85InterventionalTreatment
University of Nebraska
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:LEAP therapyno LEAP therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Macrovascular Endothelial Function
Measured over Day 1: before and after condition. Day 7: before and after condition.
+8 more outcomes measured

Conditions

Peripheral Arterial Disease
Peripheral Vascular Disease
Peripheral Artery Occlusive Disease
Peripheral Artery Disease

Explore related trials

Peripheral Artery Disease

Where it's being run

1 sites across 1 states
Nebraska1

Study leadership

  • Song-Young Park, PhD · PRINCIPAL_INVESTIGATOR · University of Nebraska

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Able to provide written informed consent
50-85 years of age
Diagnosed with Peripheral Arterial Disease (PAD) Fontaine stage II-III
Women must be postmenopausal (cessation of menses for \> 24 months)
History of exercise-induced claudication
Free of ulcers, gangrene, or necrosis of the foot, Fontaine stage IV PAD
Able to provide written informed consent
50-85 years of age
No evidence of peripheral occlusive disease, ankle-brachial index \> 0.90
Women must be postmenopausal (cessation of menses for \> 24 months)

Exclusion

Pain at rest and/or tissue loss from Peripheral Arterial Disease (PAD), Fontaine stage IV PAD
Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
Limited walking capacity from conditions other than PAD
Have not had a physical exam to assess exercise limitations in the past year
Pregnant or nursing
Kidney disease or type II diabetes mellitus
Positive diagnosis of Peripheral Arterial Disease (PAD)
Any exercise limitations as determined at last physical exam, at least 1 year prior to study
Have not had a physical exam to assess exercise limitations in the past year
Limited walking capacity from musculoskeletal injury
Pregnant or nursing
Kidney disease or type II diabetes mellitus

What this trial measures

  • Macrovascular Endothelial FunctionDay 1: before and after condition. Day 7: before and after condition.

    Macrovascular endothelial function will be measured non-invasively using the flow-mediated dilation (FMD) technique in the brachial and popliteal arteries using a Doppler ultrasound. These measures will be performed before and after 2.5 hours of prolonged sitting with LEAP therapy, and before and after 2.5 hours of prolonged sitting without LEAP therapy.

  • Microvascular Vasodilatory CapacityDay 1: before and after condition. Day 7: before and after condition.

    Microvascular vasodilatory capacity will be measured as the near-infrared spectroscopy (NIRS) reoxygenation rate in the medial gastrocnemius after an arterial occlusion. These measures will be performed before and after 2.5 hours of prolonged sitting with LEAP therapy, and before and after 2.5 hours of prolonged sitting without LEAP therapy.

  • Femoral and Popliteal Artery Blood FlowDay 1: before and after condition. Day 7: before and after condition.

    Femoral and popliteal artery blood flow will be measured in both legs using Doppler ultrasound. These measures will be performed before and after 2.5 hours of prolonged sitting with LEAP therapy, and before and after 2.5 hours of prolonged sitting without LEAP therapy.

  • Walking capacityDay 1: before and after condition. Day 7: before and after condition.

    Physical walking capacity will be measured during the Gardner treadmill protocol. Participants will walk on a treadmill at 2.0 miles per hour (mph). Grade will began at zero and will be increased by two percent every two minutes. Participants unable to walk at least 2.0 mph begin walking at 0.5 mph and their speed is increased by 0.50 mph every two minutes until the participant reaches 2.0 mph. After reaching 2.0 mph, treadmill grade is increased by two percent every two minutes. Participants are asked to continue walking without stopping until they cannot continue because of leg symptoms, exhaustion, or other symptoms. These measures will be performed before and after 2.5 hours of prolonged sitting with LEAP therapy, and before and after 2.5 hours of prolonged sitting without LEAP therapy.

  • Autonomic FunctionDay 1: before and after condition. Day 7: before and after condition.

    Autonomic nervous system function will be measured non-invasively using heart rate variability via the head-up tilt test. Raw R-R interval data will be converted to time frequency domain with the wavelet transform across the frequency intervals 0.04-0.15 Hz (low-frequency, (LF)) and 0.15-0.4 Hz (high-frequency, HF). Units for both will be expressed as ms\^2. Final outcome measure will be the ratio of LF/HF, which is a unitless ratio to indicate sympathetic-to-parasympathetic nervous system function. These measures will be performed before and after 2.5 hours of prolonged sitting with LEAP therapy, and before and after 2.5 hours of prolonged sitting without LEAP therapy.

  • Autonomic ActivityDay 1: during the condition. Day 7: during the condition

    Autonomic activity will be measured with a 3-lead ECG system (7700 Series, IvyBiomedical Systems Inc., Branford, CT) and will be used to continuously collect heart electrical activity during prolonged sitting with LEAP therapy, and prolonged sitting without LEAP therapy. Raw R-R interval data will be converted to time frequency domain with the wavelet transform across the frequency intervals 0.04-0.15 Hz (low-frequency, (LF)) and 0.15-0.4 Hz (high-frequency, HF). Units for both will be expressed as ms\^2. Final outcome measure will be the ratio of LF/HF, which is a unitless ratio to indicate sympathetic-to-parasympathetic nervous system function.

  • Arterial StiffnessDay 1: before and after condition. Day 7: before and after condition.

    Peripheral and central arterial stiffness will be assessed non-invasively using pulse-wave velocity via the applanation tonometry technique. These measures will be performed before and after 2.5 hours of prolonged sitting with LEAP therapy, and before and after 2.5 hours of prolonged sitting without LEAP therapy.

  • Muscle OxygenationDay 1: during the condition. Day 7: during the condition

    A near-infrared spectroscopy (NIRS) sensor will be adhered on the skin above the belly of the medial gastrocnemius muscle to non-invasively assess muscle oxygenation during the entire prolonged sitting bout with LEAP therapy, and the entire prolonged sitting bout without LEAP therapy.

  • Peripheral blood mononuclear cell mitochondrial functionDay 1: before and after condition. Day 7: before and after condition.

    Participants will have blood drawn from an antecubital vein, which will be used to isolate peripheral blood mononuclear cells (PBMCs) and assess their mitochondrial function. These measures will be performed before and after 2.5 hours of prolonged sitting with LEAP therapy, and before and after 2.5 hours of prolonged sitting without LEAP therapy.