Exercise Rehabilitation in Veterans With PAD

NCT02607046 | Completed Results

• 2 other identifiers: F1927-PI21RX001927
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Keywords

rehabilitation; exercise training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Muscle Perfusion Measured by Ultrasound Scan

  3 months

Study Arms (2)

Exercise

EXPERIMENTAL

Exercise Training

Other: Exercise training

NMES

EXPERIMENTAL

Neuromuscular Electrical Stimulation

Other: NMES

Interventions

Exercise training OTHER

The exercise program includes supervised and home-based walking and strength exercise.

Exercise

NMES OTHER

This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.

NMES

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cancer under active treatment
• Planned for lower extremity bypass surgery
• Body mass index \> 45 kg/m2
• Critical limb ischemia or lower extremity gangrene

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (4)

• 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.

  PMID: 28691118 RESULT

• 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.

  PMID: 29138051 RESULT

• 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.

  PMID: 28835180 RESULT

• 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. 2024 Feb;79(2):397-404. doi: 10.1016/j.jvs.2023.10.005. Epub 2023 Oct 14.

  PMID: 37844848 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Interventions

Exercise

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Steven Prior
• Organization: Department of Veterans Affairs

steven.prior@va.gov

410-605-7000

Study Officials

• Steven J. Prior, PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 17, 2015
• Study Start: October 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 20, 2023
• Last Updated: January 18, 2024
• Results First Posted: February 15, 2021

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)