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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorUniversity of Nebraska

About 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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • LEAP therapy
  • no LEAP therapy

Treatment groups

24 Participants
are divided into 4 treatment groups

Sponsors and collaborators