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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: t
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⁃ PAD subjects:

• 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

⁃ Age-matched control subjects:

• 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)

Locations
United States
Nebraska
University of Nebraska - Omaha
RECRUITING
Omaha
Contact Information
Primary
Song-Young Park, PhD
song-youngpark@unomaha.edu
402-554-3374
Time Frame
Start Date: 2024-08-16
Estimated Completion Date: 2026-08
Participants
Target number of participants: 24
Treatments
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.
Sponsors
Leads: University of Nebraska

This content was sourced from clinicaltrials.gov

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