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New treatment option for Peripheral Arterial Disease
Official title Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease
ClinicalTrials.gov ID: NCT06389149
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 85. Healthy volunteers may be eligible.
You may be able to join if
- PAD people:
- 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)
You likely can't join if
- PAD people:
- 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
See the full eligibility criteria
- PAD people:
- 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 people:
- 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)
- PAD people:
- 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 people:
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.