Improving Walking in Peripheral Artery Disease

NCT ID: NCT05103280

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-09-30

Brief Summary

Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis that blocks the leg arteries and results in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgical service of the Omaha Veterans Affairs Medical Center. PAD also accounts for one-third of the operations performed in the VA Medical Centers nationwide. The risk of mortality of Veterans with PAD is substantial; nearly 30% of Veterans with PAD died within 3.8 years of diagnosis. This project aims to establish the feasibility and acceptability of specially designed assistive shoes in patients with PAD and to determine if there are any potential benefits of using these shoes over standard shoes. These assistive shoes may enable patients to carry out desired activities of daily living with less pain and more physical activity. Increasing physical activity will decrease morbidity and mortality. If proven beneficial, the findings will lead to a novel and conservative rehabilitation protocol that directly benefits Veterans nationwide.

Detailed Description

The long-term goal of this project is to improve mobility, functional independence, and quality of life in patients with peripheral artery disease (PAD) by using specially designed assistive shoes. PAD is a manifestation of systemic atherosclerosis, producing blockages in the leg arteries, resulting in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgical service of the Omaha Veterans Affairs Medical Center. PAD also accounts for one-third of the operations performed nationwide in the VA. Walking-induced muscle pain, known as intermittent claudication, is the most common PAD symptom. Claudicating patients with PAD walk slower, have reduced quality of life and lose independence in performing activities of daily living. The investigators have identified consistent deficits of the ankle plantarflexors to effectively push-off during walking. Currently, there is a critical treatment gap for patients whose disease presentation does not warrant an operative approach, but who desire to restore their functional independence and walking ability. Specially designed assistive shoes (carbon fiber: CF; spring-loaded: SL) with specific mechanical properties to absorb and release energy, have been shown to promote push-off efficiency in walkers and runners. These shoes may lead to improved push-off in populations with reduced ankle push-off capacity, but this has not been tested yet. This work proposes to evaluate patient preferences in terms of using assistive shoes and whether these shoes improve walking performance in claudicating patients with PAD. The investigators hypothesize that using assistive shoes (either CF or SL, based on their preference) for three months will lead to improved walking performance in patients with PAD. The investigators also hypothesize that the subject-reported preference of assistive shoes (CF versus SL) will be positive based on comfort, fatigue, ease of walking, and feasibility at the baseline session. Two hypotheses will be tested by the following three specific aims:

Aim 1: Determine the subject-reported preference of assistive shoes at the Baseline visit.

Aim 2: Determine the progressive improvements in physical activity, quality of life, and walking distance after a three-month assistive shoe intervention.

Twenty patients with PAD will be recruited. Aim 1 will primarily focus on qualitative measurements of subjects' reported preferences to identify which assistive shoes are feasible for patients with PAD to use during the three months of intervention. Visual-analog scales, rate of perceived exertion, and interviews will be used to assess comfort, fatigue, intensity, and feasibility after each shoe condition of Aim 1. Patients will wear the preferred assistive shoes of their choice for regular daily use for three months as a conservative intervention. Physical activity, quality of life, and walking distances will be assessed prior to the start of the intervention and after three months of intervention. Overall, the aims will demonstrate the feasibility and acceptability of assistive shoes in patients with PAD. Results will support a full clinical trial and guide necessary intervention length and potential rehabilitation recommendations.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Progressive improvement in walking performance

A total of ten patients with peripheral artery disease will be enrolled for this arm and wear the assistive tennis shoes for three-months as an intervention.

Group Type: EXPERIMENTAL

Assistive tennis shoes

Intervention Type: OTHER

Assistive shoes include carbon-fiber and spring loaded shoes.

Interventions

Assistive tennis shoes

Assistive shoes include carbon-fiber and spring loaded shoes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

At entry into the study, all patients must:

• be able to give written, informed consent
• demonstrate positive history of chronic claudication
• have an ankle brachial index < 0.90 at rest
• have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks

Exclusion Criteria

Any potential subjects will be excluded if they have:

• rest pain or tissue loss due to peripheral artery disease (Fontaine stage III and IV)
• acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
• walking capacity significantly limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara A. Myers, PhD

Role: PRINCIPAL_INVESTIGATOR

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Locations

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

I21RX003877

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F3877-P

Identifier Type: -

Identifier Source: org_study_id