Leg exercise therapy for improving blood flow in patients with peripheral artery disease
Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease
This study is testing a new leg exercise therapy to see if it can help improve blood flow for people with peripheral artery disease when they are sitting for a long time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT06389149 on ClinicalTrials.gov |
What this trial studies
This study tests the effects of leg exercise assistive paddling (LEAP) therapy on vascular and functional performance in individuals with peripheral artery disease (PAD) and age-matched controls. LEAP therapy involves passive movement of the lower leg to enhance blood flow without muscular contractions, specifically rotating the leg from 90 to 180 degrees at a cadence of 1Hz. Participants will undergo a randomized cross-over design with two visits, one involving LEAP therapy and the other without. The goal is to determine if this novel approach can improve blood flow during prolonged sitting, a common issue for those with PAD.
Who should consider this trial
Good fit: Ideal candidates include adults aged 50-85 diagnosed with Fontaine stage II-III peripheral artery disease.
Not a fit: Patients with advanced PAD (Fontaine stage IV), experiencing pain at rest, or with other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve blood flow and functional capacity in patients with peripheral artery disease.
How similar studies have performed: While exercise therapies have shown effectiveness in improving outcomes for PAD, the specific application of LEAP therapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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) 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
Where this trial is running
Omaha, Nebraska
- University of Nebraska - Omaha — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Song-Young Park, PhD — University of Nebraska
- Study coordinator: Song-Young Park, PhD
- Email: song-youngpark@unomaha.edu
- Phone: 402-554-3374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.