Actively Recruiting

Phase Not Applicable
Age: 55Years - 85Years
All Genders
Healthy Volunteers
NCT06389149

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

Led by University of Nebraska · Updated on 2025-10-01

24

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 55Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide written informed consent
  • Age between 50 and 85 years
  • Diagnosed with Peripheral Arterial Disease (PAD) Fontaine stage II-III (for PAD subjects)
  • Women must be postmenopausal (no menstrual periods for over 24 months)
  • History of exercise-induced claudication (for PAD subjects)
  • No ulcers, gangrene, or necrosis of the foot (no Fontaine stage IV PAD)
  • No evidence of peripheral occlusive disease with ankle-brachial index > 0.90 (for control subjects)
Not Eligible

You will not qualify if you...

  • Pain at rest or tissue loss from PAD (Fontaine stage IV) (for PAD subjects)
  • Acute lower extremity ischemic event due to thromboembolic disease or trauma (for PAD subjects)
  • Limited walking capacity from causes other than PAD (for PAD subjects)
  • No physical exam to assess exercise limitations in the past year
  • Pregnant or nursing
  • Kidney disease or type II diabetes mellitus
  • Positive diagnosis of PAD (for control subjects)
  • Exercise limitations at last physical exam at least 1 year ago (for control subjects)
  • Limited walking capacity from musculoskeletal injury (for control subjects)

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Nebraska - Omaha

Omaha, Nebraska, United States, 68182

Actively Recruiting

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Research Team

S

Song-Young Park, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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