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Exercise Rehabilitation in Veterans With PAD

Primary Purpose

Peripheral Arterial Disease, Intermittent Claudication

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
NMES
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring rehabilitation, exercise training

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise

NMES

Arm Description

Exercise Training

Neuromuscular Electrical Stimulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 13, 2015
Last Updated
January 18, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02607046
Brief Title
Exercise Rehabilitation in Veterans With PAD
Official Title
Post-revascularization Rehabilitation to Improve Function in Veterans With PAD
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Intermittent Claudication
Keywords
rehabilitation, exercise training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise Training
Arm Title
NMES
Arm Type
Experimental
Arm Description
Neuromuscular Electrical Stimulation
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
The exercise program includes supervised and home-based walking and strength exercise.
Intervention Type
Other
Intervention Name(s)
NMES
Intervention Description
This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.
Primary Outcome Measure Information:
Title
Modified Physical Performance Test
Description
Test of Mobility Function (minimum score = 0; maximum score = 36; higher score associated with better outcome)
Time Frame
3 months
Title
Six-minute Walk Distance
Description
Test of ambulatory capacity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Muscle Perfusion Measured by Ultrasound Scan
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J. Prior, PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise Rehabilitation in Veterans With PAD

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