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Behavioural Intervention

Control: No LEAP therapy, then LEAP therapy for Peripheral Arterial Disease

N/A

Waitlist Available

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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Arterial Stiffness

Autonomic Activity

Autonomic Function

+6 more

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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

540 Previous Clinical Trials

1,144,711 Total Patients Enrolled

12 Trials studying Peripheral Arterial Disease

504 Patients Enrolled for Peripheral Arterial Disease

Song-Young Park, PhDPrincipal InvestigatorUniversity of Nebraska

3 Previous Clinical Trials

38 Total Patients Enrolled

1 Trials studying Peripheral Arterial Disease

20 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants older than 80 years of age eligible for enrollment in this study?

"The eligible participants for this investigation must fall within the age range of 55 to 85 years. Notably, there are a total of 12 studies focusing on individuals under 18 and an additional 262 trials involving those above 65 years old."

Answered by AI

Are there any ongoing opportunities for individuals to participate in this research study?

"The information available on clinicaltrials.gov states that this particular trial is no longer seeking participants. Initially shared on August 1st, 2024, the last update occurred on April 24th of the same year. Despite its closure to new candidates, there are currently 277 alternative trials ready to accept participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06389149.

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