Activity To Improve Outcomes in Peripheral Arterial Disease (ACTION)

July 26, 2023 updated by: Brajesh K Lal, Baltimore VA Medical Center
Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs 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 is being implemented in adults with PAD to examine the effects of exercise or weight loss programs on lower extremity blood flow, health, and physical function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pilot study seeks to gather data on different exercise interventions in PAD. Collectively, the proposed studies will gather data on the role of novel exercise interventions in those with PAD who are receiving conservative treatment as well as those who have undergone an endovascular intervention for lower extremity arterial disease.

We hypothesize that patients who undergo an exercise intervention will: A) show improved lower extremity perfusion and B) improve their functional ability, compared to a standard care control group over 6 months of follow-up. We further hypothesize that these improvements are mediated through angiogenesis and increased perfusion of the lower limb, as well as improvements in muscle strength, mass, and function.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 21-90 years
  • Ankle brachial index < 0.9

Exclusion Criteria:

  • Cancer under active treatment, except prostate, skin, and hematologic cancers
  • Planned for open lower extremity bypass surgery
  • Body mass index >45
  • Lower extremity gangrene

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Ad lib activity at home
Other: Ad lib activity at home
Ad lib activity at home
Experimental: Active Exercise
Active exercise on treadmill
Other: Active Exercise
Active exercise on a treadmill
Experimental: Neuromuscular electrical stimulation
Other: Neuromuscular electrical stimulation
Neuromuscular electrical stimulation
Experimental: Weight loss and active exercise
Weight loss plus active exercise on treadmill
Other: Weight loss and active exercise
Weight loss and active exercise on a treadmill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower extremity perfusion
Time Frame: 6 months
Ankle brachial index and ultrasound quantification of muscle perfusion
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity
Time Frame: 6 months
Treadmill exercise testing
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baltimore VA Medical Center

Investigators

  • Principal Investigator: Brajesh K Lal, MD, Baltimore VAMC, University of Maryland School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

July 4, 2023

Study Completion (Actual)

July 4, 2023

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimated)

July 14, 2014

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00059151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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