Exercise Rehabilitation in Veterans With PAD

Study Overview
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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.

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.

Official Title
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Post-revascularization Rehabilitation to Improve Function in Veterans With PAD

Conditions
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Peripheral Arterial Disease, Intermittent Claudication

Intervention / Treatment
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* Other: Exercise training
* Other: NMES


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Exercise Training | Other: Exercise training<br>* The exercise program includes supervised and home-based walking and strength exercise.<br>|
| Experimental: NMES<br>Neuromuscular Electrical Stimulation | Other: NMES<br>* This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Physical Performance Test | Test of Mobility Function (minimum score = 0; maximum score = 36; higher score associated with better outcome) | 3 months | 
| Six-minute Walk Distance | Test of ambulatory capacity | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Perfusion Measured by Ultrasound Scan | Calf Muscle Perfusion assessed as digital video intensity from recorded ultrasound scans. Units are scale data with a minimum = 0 and no predetermined maximum. Higher score = more perfusion. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, exercise training