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

Launched by UNIVERSITY OF NEBRASKA · Apr 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of therapy called Leg Exercise Assistive Paddling (LEAP) therapy to see if it can help improve blood flow and physical performance in people with Peripheral Artery Disease (PAD). LEAP therapy involves a method of moving the legs passively, which means the legs are moved without any muscle effort from the person. The researchers want to find out if this therapy can help those with PAD while they are sitting for extended periods, as many people with this condition experience pain when they exercise.

To participate in this study, individuals with PAD need to be between 50 and 85 years old, have a specific type of PAD that causes exercise-related leg pain, and must be postmenopausal if they are women. Participants will attend two visits where they will either receive the LEAP therapy or not during a 2.5-hour sitting session. They will undergo various tests to measure blood flow and walking ability before and after the sitting period. It’s important to note that participants will not need to return for follow-up visits after the study is completed. If you or someone you know might be eligible and interested in this study, it could be a great opportunity to help researchers learn more about improving care for individuals with PAD.

Gender

ALL

Eligibility 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