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Exercise Rehabilitation in Veterans With PAD

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ClinicalTrials.gov Identifier: NCT02607046
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
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 and neuromuscular stimulation on leg blood flow, physical function, quality of life and general health.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Intermittent Claudication Other: Exercise training Other: NMES Not Applicable

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. Together, these two therapies may work in a complementary manner 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; b) Treadmill tests to assess ambulatory capacity, and calf muscle perfusion; and c) A gastrocnemius needle biopsy to measure capillary density and angiogenic growth factor expression. Participants will undergo baseline testing prior to revascularization and will repeat research testing 2-3 weeks after revascularization to determine the effect of only revascularization on functional outcomes. After post-revascularization testing, 52 patients will be randomized to one of four groups (Exercise-only, NMES-only, Exercise+NMES, or Standard Care; n=13/group). After completion of the 3-month intervention, participants will repeat all tests to determine the effects of the interventions compared to standard care.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-revascularization Rehabilitation to Improve Function in Veterans With PAD
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Standard Medical Care
Experimental: Exercise
Exercise Training
Other: Exercise training
The exercise program includes supervised treadmill walking and home-based walking 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.

Experimental: Exercise + NMES
Combined Exercise Training and Neuromuscular Electrical Stimulation
Other: Exercise training
The exercise program includes supervised treadmill walking and home-based walking exercise.

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




Primary Outcome Measures :
  1. Modified Physical Performance Test [ Time Frame: 3 months ]
    Test of Mobility Function

  2. Six-minute walk distance [ Time Frame: 3 months ]
    Test of ambulatory capacity


Secondary Outcome Measures :
  1. Muscle perfusion measured by ultrasound scan [ Time Frame: 3 months ]
    Calf muscle perfusion



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607046


Contacts
Contact: Eric Christensen, MS (410) 605-7000 ext 5431 echristensen@medicine.umaryland.edu
Contact: Coutrney Eberhardt, MS (410) 605-7000 ext 55444 Courtney.Eberhardt@va.gov

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Eric Christensen, MS    410-605-7000 ext 5431    echristensen@medicine.umaryland.edu   
Principal Investigator: Steven J. Prior, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Steven J. Prior, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02607046     History of Changes
Other Study ID Numbers: F1927-P
I21RX001927 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by VA Office of Research and Development:
rehabilitation
exercise training

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms