Exercise Rehabilitation in Veterans With PAD

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease; Intermittent Claudication
• Interventions: Other: Exercise training; Other: NMES

• Registration Number: NCT02607046
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-17
• Primary Completion: 2019-12-31
• Results First Submitted: 2020-12-23
• Results First Submitted QC: 2021-01-26
• Results First Posted: 2021-02-15
• Status Verified: 2023-12
• Study Completion: 2023-12-20
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise training	Exercise Training
NMES	NMES	Neuromuscular Electrical Stimulation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Muscle Perfusion Measured by Ultrasound Scan	3 months	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.

Trial Locations

Locations (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD; 🇺🇸 Baltimore, Maryland, United States