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Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease
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. To be eligible for this study, those with PAD must be between the ages of 50-85 years, women must be postmenopausal, must have a history of exercise-limiting claudication, have an ankle brachial index (ABI) 0.9. 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. There will be no follow-up.
Conditions:
🦠 Peripheral Arterial Disease 🦠 Peripheral Vascular Disease 🦠 Peripheral Artery Occlusive Disease 🦠 Peripheral Artery Disease
🗓️ Study Start (Actual) August 2024
🗓️ Primary Completion (Estimated) August 2025
✅ Study Completion (Estimated) August 2025
👥 Enrollment (Estimated) 24
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Omaha, Nebraska, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • At entry into the study, PAD subjects must:
    • 1. be able to provide written informed consent
    • 2. be between the ages of 50-85
    • 3. be diagnosed as Fontaine stage II-III
    • 4. women must be postmenopausal (cessation of menses for \> 24 mo)
    • 5. demonstrate a history of exercise-induced claudication
    • 6. must not have ulcers, gangrene, or necrosis of the foot (Fontaine stage IV PAD)
    • 7. not have kidney disease or type II diabetes mellitus
    • At entry into the study, age-matched control subjects must:
    • 1. be able to provide written informed consent
    • 2. be between the ages of 50-85
    • 3. have no evidence of peripheral occlusive disease (ankle-brachial index \> 0.90)
    • 4. women must be postmenopausal (cessation of menses for \> 24 mo)
    • 5. not have kidney disease or type II diabetes mellitus

    Exclusion Criteria:

    • Potential subjects with PAD will be deemed ineligible if they:
    • 1. have pain at rest and/or tissue loss due to PAD (Fontaine stage IV PAD)
    • 2. have an acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
    • 3. have limited walking capacity due to conditions other than PAD
    • 4. have not had a physical exam to assess exercise limitations in the past year.
    • 5. are currently pregnant or nursing
    • 6. currently have kidney disease or type II diabetes mellitus
    • Potential age-matched control subjects will be deemed ineligible if they:
    • 1. have a positive diagnosis of PAD
    • 2. have any exercise limitations as determined by a doctor at their last physical exam (at or before 1 year prior to the study)
    • 3. have not had a physical exam to assess exercise limitations in the past year.
    • 4. have limited walking capacity from musculoskeletal injury
    • 5. are currently pregnant or nursing
    • 6. currently have kidney disease or type II diabetes mellitus
Ages Eligible for Study: 55 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 24 April 2024
  • First Submitted that Met QC Criteria 24 April 2024
  • First Posted 29 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 31 May 2024
  • Last Update Posted 3 June 2024
  • Last Verified May 2024