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Behavioural Intervention

LEAP Therapy for Peripheral Artery Disease

N/A

Recruiting

Led By Song-Young Park, PhD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PAD subjects must be postmenopausal women (cessation of menses for > 24 mo)

PAD subjects must not have ulcers, gangrene, or necrosis of the foot (Fontaine stage IV PAD)

Must not have

PAD subjects with pain at rest and/or tissue loss due to PAD (Fontaine stage IV PAD)

PAD subjects with limited walking capacity due to conditions other than PAD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1: during the condition. day 7: during the condition

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the effects of a new leg exercise therapy called LEAP on blood flow and function in individuals with peripheral artery disease (PAD) and age-matched controls. Participants will undergo passive

Who is the study for?

This trial is for individuals aged 50-85 with peripheral artery disease (PAD), specifically those who experience exercise-limiting claudication and have an ankle brachial index (ABI) ≤0.9. Women must be postmenopausal to participate. The study aims to include both PAD patients and age-matched controls.

What is being tested?

The LEAP therapy, which involves passive leg movements to boost blood flow without muscle contractions, is being tested against no therapy during prolonged sitting sessions of 2.5 hours. Participants will undergo two sessions in a randomized order: one with LEAP therapy and one without.

What are the potential side effects?

Since the intervention involves non-strenuous passive movement, significant side effects are not anticipated; however, discomfort or fatigue from sitting may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a postmenopausal woman (no periods for over 24 months).

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I do not have ulcers or dead tissue on my foot due to poor blood flow.

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I do not have kidney disease or type II diabetes.

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I do not have kidney disease or type II diabetes.

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I am between 50 and 85 years old.

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My PAD is at Fontaine stage II-III, meaning I have moderate to severe leg pain.

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I do not have blocked arteries in my legs (ankle-brachial index above 0.90).

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I am a postmenopausal woman (no menstrual periods for over 24 months).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe leg pain or tissue loss due to poor blood flow.

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My walking is limited due to reasons other than PAD.

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I have kidney disease or type II diabetes along with PAD.

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I am currently pregnant or nursing.

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I have PAD and recently had a leg issue due to a clot or injury.

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I have kidney disease or type II diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1: during the condition. day 7: during the condition

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1: during the condition. day 7: during the condition

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: during the condition. day 7: during the condition for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Arterial Stiffness

Autonomic Activity

Autonomic Function

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: PAD: No LEAP therapy, then LEAP therapyExperimental Treatment2 Interventions

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 II: PAD: LEAP therapy, then no LEAP therapyExperimental Treatment2 Interventions

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 III: Control: No LEAP therapy, then LEAP therapyExperimental Treatment2 Interventions

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 IV: Control: LEAP therapy, then no LEAP therapyExperimental Treatment2 Interventions

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.

0 / 14Eligibility criteria met