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

Description

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Peripheral Arterial Disease
Intervention / Treatment

-

Contacts and Locations

Omaha

University of Nebraska - Omaha, Omaha, Nebraska, United States, 68182

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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

Ages Eligible for Study

55 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Nebraska,

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

Study Record Dates

2025-08