Exercise Rehabilitation in Veterans With PAD

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2023-12-20

Brief Summary

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Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project will be conducted patients with PAD that require revascularization. The goal is to examine the effects of 3 months of exercise rehabilitation or neuromuscular stimulation on leg blood flow, physical function, quality of life and general health.

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Detailed Description

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Peripheral artery disease (PAD) and its associated declines in physical function impair quality of life (QOL) in nearly 20% of older Veterans and result in substantial VA health care costs. Revascularization addresses the anatomical pathology, but does not restore mobility function and QOL. Optimal therapy may require post-revascularization rehabilitation to address lingering defects in skeletal muscle that limit function; however, the current standard of care after revascularization does not include rehabilitation. Exercise training and neuromuscular electrical stimulation (NMES) may enhance function by increasing muscle perfusion to improve outcomes in older Veterans with PAD after revascularization.

The investigators will enroll Veterans (50-80 years of age) with PAD who are planned for percutaneous revascularization. Participants will complete research testing consisting of: a) Assessment of mobility function and QOL; and b) Treadmill tests to assess ambulatory capacity, and calf muscle perfusion. Participants will undergo screening prior to revascularization and will have baseline testing 2-3 weeks after revascularization. After post-revascularization testing, patients will be randomized to Exercise-only or NMES-only. After completion of the 3-month intervention, participants will repeat all tests to determine the effects of the interventions.

Conditions

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Peripheral Arterial Disease Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

Exercise Training

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

The exercise program includes supervised and home-based walking and strength exercise.

NMES

Neuromuscular Electrical Stimulation

Group Type EXPERIMENTAL

NMES

Intervention Type OTHER

This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.

Interventions

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Exercise training

The exercise program includes supervised and home-based walking and strength exercise.

Intervention Type OTHER

NMES

This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of peripheral arterial disease; or ankle-brachial index \<0.9.
* Planned to undergo endovascular revascularization within 6 months.

Exclusion Criteria

* Cancer under active treatment
* Planned for lower extremity bypass surgery
* Body mass index \> 45 kg/m2
* Critical limb ischemia or lower extremity gangrene

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes