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

Recruiting now · Not applicable

Conditions studied: Peripheral Arterial Disease, Peripheral Vascular Disease, Peripheral Artery Occlusive Disease, Peripheral Artery Disease

In brief

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.

Key facts

Study ID: NCT06389149
Run by: University of Nebraska
People needed: 24
Starts: 2024-08-16
Expected to finish: 2026-08-01
Last updated by the study team: 2025-10-01

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

University of Nebraska - Omaha — Omaha, Nebraska, United States (enrolling)

Full record on ClinicalTrials.gov

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