NCT02607046

Exercise Rehabilitation in Veterans With PAD

Post-revascularization Rehabilitation to Improve Function in Veterans With PAD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

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

• Peripheral Arterial Disease
• Intermittent Claudication

Interventions

Type	Name	Description
OTHER	Exercise training	The exercise program includes supervised and home-based walking and strength exercise.
OTHER	NMES	This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-12-31
• Completion: 2023-12-20
• First posted: 2015-11-17
• Last updated: 2024-01-18
• Results posted: 2021-02-15

Locations

1 site across 1 country: United States