NCT06389149 Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease
| NCT ID | NCT06389149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nebraska |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-08-16 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-08-16 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: PAD subjects: * 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 Age-matched control subjects: * 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 Criteria: PAD subjects: * 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 Age-matched control subjects: * 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
Contact & Investigator
Song-Young Park, PhD
PRINCIPAL INVESTIGATOR
University of Nebraska
Frequently Asked Questions
Who can join the NCT06389149 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 85 Years, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06389149 currently recruiting?
Yes, NCT06389149 is actively recruiting participants. Contact the research team at song-youngpark@unomaha.edu for enrollment information.
Where is the NCT06389149 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT06389149 clinical trial?
NCT06389149 is sponsored by University of Nebraska. The principal investigator is Song-Young Park, PhD at University of Nebraska. The trial plans to enroll 24 participants.