Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
52

Summary

Conditions
  • Intermittent Claudication
  • Peripheral Arterial Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 50 years and 80 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT02607046
Collaborators
Not Provided
Investigators
Principal Investigator: Steven J. Prior, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD