Exercise Rehabilitation in Veterans With PAD

Post-revascularization Rehabilitation to Improve Function in Veterans With PAD

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Intermittent Claudication
• Intervention / Treatment: Other: Exercise training; Other: NMES

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Steven J. Prior, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Publications and helpful links

General Publications

• Kundi R, Prior SJ, Addison O, Lu M, Ryan AS, Lal BK. Contrast-Enhanced Ultrasound Reveals Exercise-Induced Perfusion Deficits in Claudicants. J Vasc Endovasc Surg. 2017;2(1):9. doi: 10.21767/2573-4482.100041. Epub 2017 Mar 6.
• Addison O, Prior SJ, Kundi R, Serra MC, Katzel LI, Gardner AW, Ryan AS. Sarcopenia in Peripheral Arterial Disease: Prevalence and Effect on Functional Status. Arch Phys Med Rehabil. 2018 Apr;99(4):623-628. doi: 10.1016/j.apmr.2017.10.017. Epub 2017 Nov 11.
• Addison O, Kundi R, Ryan AS, Goldberg AP, Patel R, Lal BK, Prior SJ. Clinical relevance of the modified physical performance test versus the short physical performance battery for detecting mobility impairments in older men with peripheral arterial disease. Disabil Rehabil. 2018 Dec;40(25):3081-3085. doi: 10.1080/09638288.2017.1367966. Epub 2017 Aug 23.
• Prior SJ, Chrencik MT, Christensen E, Kundi R, Ryan AS, Addison O, Lal BK. An exercise stress test for contrast-enhanced duplex ultrasound assessment of lower limb muscle perfusion in patients with peripheral arterial disease. J Vasc Surg. 2023 Oct 14:S0741-5214(23)02091-8. doi: 10.1016/j.jvs.2023.10.005. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimated): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; exercise training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: F1927-P; I21RX001927 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No