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Completed

NCT Number: NCT02607046

Exercise Rehabilitation 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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training

Other

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

NMES

Other

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

Primary outcomes

  1. Modified Physical Performance Test

    Time frame: 3 months

    Test of Mobility Function (minimum score = 0; maximum score = 36; higher score associated with better outcome)

  2. Six-minute Walk Distance

    Time frame: 3 months

    Test of ambulatory capacity

Secondary outcomes

  1. Muscle Perfusion Measured by Ultrasound Scan

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Post-revascularization Rehabilitation to Improve Function in Veterans With PAD

Important dates

Study start
2015
Primary completion
2019
Study completion
2023
First posted
Nov 17, 2015
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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