Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease
NCT ID: NCT06389149
Last Updated: 2025-10-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-08-16
Study Completion Date
2026-08-31
Brief Summary
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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.
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.
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Detailed Description
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Epidemiological studies suggest that over 200 million adults worldwide currently have peripheral artery disease (PAD), which is the buildup of atherosclerotic plaques in the arteries of the legs and is associated with high rates of morbidity and mortality. The population most suspectable to PAD is older adults, with the incidence of PAD increasing exponentially after the age of 50. This sharp age demarcation makes PAD particularly concerning for Western societies, where the proportion of older adults is steadily rising, thereby making PAD a large potential future burden to healthcare systems and economies alike. Therefore, the discovery and development of interventions to prevent and treat PAD is a top biomedical concern that has a high future return on investments.
Exercise and physical activity are known to improve functional capacity in those with PAD. In fact, exercise therapies have been reported to be as effective as revascularization surgeries at restoring functional walking capacity. However, despite the major benefits of exercise, adherence to supervised exercise therapies is low, and those with PAD report being highly sedentary, which is likely attributed to the muscle pain they experience during exercise. Elevated sedentarism among those with PAD is concerning, since the investigators and others have demonstrated that sedentarism in the form of prolonged sitting (i.e., sitting for \>1 hour) can 1) increase arterial stiffness, 2) reduce the vasodilatory capacities of the macro- and micro-vasculatures, 3) reduce skeletal muscle metabolism, and 4) reduce shear stress in the large conduit arteries, all of which are known to promote atherosclerosis. Importantly, since those with PAD already demonstrate impaired vascular function, they may be more suspectable to the negative effects of prolonged sitting on vascular health. Remarkably, the investigators have shown that passive movement of the legs (i.e., limb movement without active muscle contractions) can prevent vascular decline during prolonged sitting. Therefore, passive limb movement (PLM) therapies may be an effective strategy to provide light physical activity to those with PAD and protect them against the deleterious effects of sedentarism. Importantly, since PLM does not require active skeletal muscle work, it is likely that PLM will be well-tolerated by those with PAD, and adherence to PLM therapies may be enhanced compared to traditional exercise. Therefore, developing methods that mimic exercise with PLM may be an effective front-line strategy to improve functional capacity, vascular function, and quality of life in those with PAD.
Unfortunately, there are currently no available methods that provide PLM therapy for those with PAD, and it is not known whether PLM therapies can protect the vasculature of those with PAD during PS. Therefore, the investigators have developed the Leg Exercise Assistive Paddling (LEAP) protocol to provide PLM therapy during PS. LEAP therapy is a standardized protocol for those with PAD that provides PLM by rotating the lower leg about the knee from 90-180° at a cadence of 1Hz for 1 minute every 10 minutes. These parameters have been chosen for LEAP therapy because of the robust increases in leg blood flow elicited by these parameters. The investigators hypothesize that LEAP therapy prevents vascular and functional decline in those with PAD during PS. Therefore, the development and validation of LEAP therapy is expected to promote PLM therapies as a new interventional strategy to improve vascular and functional capacities in those with PAD.
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.
Exercise and physical activity are known to improve functional capacity in those with PAD. In fact, exercise therapies have been reported to be as effective as revascularization surgeries at restoring functional walking capacity. However, despite the major benefits of exercise, adherence to supervised exercise therapies is low, and those with PAD report being highly sedentary, which is likely attributed to the muscle pain they experience during exercise. Elevated sedentarism among those with PAD is concerning, since the investigators and others have demonstrated that sedentarism in the form of prolonged sitting (i.e., sitting for \>1 hour) can 1) increase arterial stiffness, 2) reduce the vasodilatory capacities of the macro- and micro-vasculatures, 3) reduce skeletal muscle metabolism, and 4) reduce shear stress in the large conduit arteries, all of which are known to promote atherosclerosis. Importantly, since those with PAD already demonstrate impaired vascular function, they may be more suspectable to the negative effects of prolonged sitting on vascular health. Remarkably, the investigators have shown that passive movement of the legs (i.e., limb movement without active muscle contractions) can prevent vascular decline during prolonged sitting. Therefore, passive limb movement (PLM) therapies may be an effective strategy to provide light physical activity to those with PAD and protect them against the deleterious effects of sedentarism. Importantly, since PLM does not require active skeletal muscle work, it is likely that PLM will be well-tolerated by those with PAD, and adherence to PLM therapies may be enhanced compared to traditional exercise. Therefore, developing methods that mimic exercise with PLM may be an effective front-line strategy to improve functional capacity, vascular function, and quality of life in those with PAD.
Unfortunately, there are currently no available methods that provide PLM therapy for those with PAD, and it is not known whether PLM therapies can protect the vasculature of those with PAD during PS. Therefore, the investigators have developed the Leg Exercise Assistive Paddling (LEAP) protocol to provide PLM therapy during PS. LEAP therapy is a standardized protocol for those with PAD that provides PLM by rotating the lower leg about the knee from 90-180° at a cadence of 1Hz for 1 minute every 10 minutes. These parameters have been chosen for LEAP therapy because of the robust increases in leg blood flow elicited by these parameters. The investigators hypothesize that LEAP therapy prevents vascular and functional decline in those with PAD during PS. Therefore, the development and validation of LEAP therapy is expected to promote PLM therapies as a new interventional strategy to improve vascular and functional capacities in those with PAD.
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
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Peripheral Arterial Disease
Peripheral Vascular Disease
Peripheral Artery Occlusive Disease
Peripheral Artery Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
There will be a peripheral artery disease (PAD) group and an age-matched healthy control group. Within each of these groups will be a 1:1 randomized, crossover study design.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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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.
Group Type
EXPERIMENTAL
LEAP therapy
Intervention Type
OTHER
Knee bending from 90°-180° at 1Hz for 1 minute every 10 minutes during 2.5 hours of prolonged sitting
no LEAP therapy
Intervention Type
OTHER
2.5 hours of uninterrupted prolonged sitting (no movement)
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.
Group Type
EXPERIMENTAL
LEAP therapy
Intervention Type
OTHER
Knee bending from 90°-180° at 1Hz for 1 minute every 10 minutes during 2.5 hours of prolonged sitting
no LEAP therapy
Intervention Type
OTHER
2.5 hours of uninterrupted prolonged sitting (no movement)
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.
Group Type
EXPERIMENTAL
LEAP therapy
Intervention Type
OTHER
Knee bending from 90°-180° at 1Hz for 1 minute every 10 minutes during 2.5 hours of prolonged sitting
no LEAP therapy
Intervention Type
OTHER
2.5 hours of uninterrupted prolonged sitting (no movement)
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.
Group Type
EXPERIMENTAL
LEAP therapy
Intervention Type
OTHER
Knee bending from 90°-180° at 1Hz for 1 minute every 10 minutes during 2.5 hours of prolonged sitting
no LEAP therapy
Intervention Type
OTHER
2.5 hours of uninterrupted prolonged sitting (no movement)
Interventions
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LEAP therapy
Knee bending from 90°-180° at 1Hz for 1 minute every 10 minutes during 2.5 hours of prolonged sitting
Intervention Type
OTHER
no LEAP therapy
2.5 hours of uninterrupted prolonged sitting (no movement)
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
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)
* 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)
Exclusion Criteria
PAD subjects:
* Pain at rest and/or tissue loss from Peripheral Arterial Disease (PAD), Fontaine stage IV PAD
* Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
* Limited walking capacity from conditions other than PAD
* Have not had a physical exam to assess exercise limitations in the past year
* Pregnant or nursing
* Kidney disease or type II diabetes mellitus
Age-matched control subjects:
* Positive diagnosis of Peripheral Arterial Disease (PAD)
* Any exercise limitations as determined at last physical exam, at least 1 year prior to study
* Have not had a physical exam to assess exercise limitations in the past year
* Limited walking capacity from musculoskeletal injury
* Pregnant or nursing
* Kidney disease or type II diabetes mellitus
* Pain at rest and/or tissue loss from Peripheral Arterial Disease (PAD), Fontaine stage IV PAD
* Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
* Limited walking capacity from conditions other than PAD
* Have not had a physical exam to assess exercise limitations in the past year
* Pregnant or nursing
* Kidney disease or type II diabetes mellitus
Age-matched control subjects:
* Positive diagnosis of Peripheral Arterial Disease (PAD)
* Any exercise limitations as determined at last physical exam, at least 1 year prior to study
* Have not had a physical exam to assess exercise limitations in the past year
* Limited walking capacity from musculoskeletal injury
* Pregnant or nursing
* Kidney disease or type II diabetes mellitus
Minimum Eligible Age
55 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Nebraska
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Song-Young Park, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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University of Nebraska - Omaha
Omaha, Nebraska, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0165-24-FB
Identifier Type: -
Identifier Source: org_study_id
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