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NCT06389149 · ClinicalTrials.gov registry record · NA
Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease
A NA study of Peripheral Arterial Disease and Peripheral Artery Disease, sponsored by University of Nebraska.
- Recruiting
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06389149: Recruiting NA study of Peripheral Arterial Disease and Peripheral Artery Disease, sponsored by University of Nebraska.
NCT06389149 is a NA study of Peripheral Arterial Disease and Peripheral Artery Disease that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 24 participants, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06389149, a NA study of Peripheral Arterial Disease and Peripheral Artery Disease, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER LEAP therapy
- OTHER no LEAP therapy
Study Locations (1)
Nebraska
- University of Nebraska - Omaha - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-08-16 |
| Est. Completion | 2026-08 |
| Phase | NA |
What NCT06389149 shows while recruiting
NCT06389149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which LEAP therapy is the first listed.
NCT06389149 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT06389149 about?
NCT06389149 is a clinical study titled "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...
What is the current status of trial NCT06389149?
This trial is currently recruiting. It is a NA study. The enrollment target is 24 participants. The study started on 2024-08-16. Estimated completion is 2026-08.
What conditions does trial NCT06389149 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Peripheral Artery Disease, Peripheral Vascular Disease, Peripheral Artery Occlusive Disease.
What interventions are being tested in trial NCT06389149?
The interventions under investigation include: LEAP therapy (OTHER), no LEAP therapy (OTHER).
Who is sponsoring clinical trial NCT06389149?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06389149 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06389149's enrollment target sits among peer trials
24 62nd of 79 higher than 17 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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