RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-16
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06389149

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.

Ages Eligible for Study:55 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide written informed consent
  2. * 50-85 years of age
  3. * Diagnosed with Peripheral Arterial Disease (PAD) Fontaine stage II-III
  4. * Women must be postmenopausal (cessation of menses for \> 24 months)
  5. * History of exercise-induced claudication
  6. * Free of ulcers, gangrene, or necrosis of the foot, Fontaine stage IV PAD
  7. * Able to provide written informed consent
  8. * 50-85 years of age
  9. * No evidence of peripheral occlusive disease, ankle-brachial index \> 0.90
  10. * Women must be postmenopausal (cessation of menses for \> 24 months)
  1. * Pain at rest and/or tissue loss from Peripheral Arterial Disease (PAD), Fontaine stage IV PAD
  2. * Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
  3. * Limited walking capacity from conditions other than PAD
  4. * Have not had a physical exam to assess exercise limitations in the past year
  5. * Pregnant or nursing
  6. * Kidney disease or type II diabetes mellitus
  7. * Positive diagnosis of Peripheral Arterial Disease (PAD)
  8. * Any exercise limitations as determined at last physical exam, at least 1 year prior to study
  9. * Have not had a physical exam to assess exercise limitations in the past year
  10. * Limited walking capacity from musculoskeletal injury
  11. * Pregnant or nursing
  12. * Kidney disease or type II diabetes mellitus

Contacts and Locations

Study Contact

Song-Young Park, PhD
CONTACT
402-554-3374
song-youngpark@unomaha.edu

Principal Investigator

Song-Young Park, PhD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Nebraska

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-16
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-08-16
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

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