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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

55 Years - 85 Years

Healthy Volunteers

Accepted

Interventions

• LEAP therapy — OTHER
  Knee bending from 90°-180° at 1Hz for 1 minute every 10 minutes during 2.5 hours of prolonged sitting
• no LEAP therapy — OTHER
  2.5 hours of uninterrupted prolonged sitting (no movement)

Study Details

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 Dates

Start date

Aug 16, 2024

Status verified

Mar 2025

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Control: LEAP therapy, then no LEAP therapy
  Participants will perform a bout of 2.5 hours of prolonged sitting with LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting without LEAP therapy.
• Experimental: Control: No LEAP therapy, then LEAP therapy
  Participants will perform a bout of 2.5 hours of prolonged sitting without LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting with LEAP therapy.
• Experimental: PAD: LEAP therapy, then no LEAP therapy
  Participants with peripheral artery disease will perform a bout of 2.5 hours of prolonged sitting with LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting without LEAP therapy.
• Experimental: PAD: No LEAP therapy, then LEAP therapy
  Participants with peripheral artery disease will perform a bout of 2.5 hours of prolonged sitting without LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting with LEAP therapy.

Primary Outcome Measure

Macrovascular Endothelial Function [ Time Frame: Day 1: before and after condition. Day 7: before and after condition. ]

Central Contacts

• Song-Young Park, PhD
  402-554-3374
  [email protected]

Locations (1)

Find similar trials in Omaha, NE

Related Studies

• Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
  PHASE4 · Recruiting · University of Nebraska · Omaha, Nebraska
• Oxygen-guided Supervised Exercise Therapy
  Recruiting · VA Office of Research and Development · Omaha, Nebraska
• Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease
  EARLY_PHASE1 · Recruiting · University of Nebraska · Omaha, Nebraska
• MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology
  Recruiting · University of Nebraska · Omaha, Nebraska