Exercise Rehabilitation in Veterans With PAD

VA Office of Research and Development

Status: Completed

Conditions: Intermittent Claudication; Peripheral Arterial Disease

Treatments: Other: Exercise training; Other: NMES

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02607046

F1927-P

I21RX001927 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 56 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Exercise

Experimental group

Description:

Exercise Training

Treatment:

Other: Exercise training

NMES

Experimental group

Description:

Neuromuscular Electrical Stimulation

Treatment:

Other: NMES