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Activity To Improve Outcomes in Peripheral Arterial Disease (ACTION)

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ClinicalTrials.gov Identifier: NCT02189018
Recruitment Status : Enrolling by invitation
First Posted : July 14, 2014
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Brajesh K Lal, Baltimore VA Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Occlusive Disease Other: Active Exercise Other: Neuromuscular electrical stimulation Other: Weight loss and active exercise Other: Ad lib activity at home Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Activity To Improve Outcomes in Peripheral Arterial Disease
Actual Study Start Date : August 2014
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

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Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  1. Lower extremity perfusion [ Time Frame: 6 months ]
    Ankle brachial index and ultrasound quantification of muscle perfusion


Secondary Outcome Measures :
  1. Functional capacity [ Time Frame: 6 months ]
    Treadmill exercise testing


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02189018


Locations
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United States, Maryland
Baltimore VAMC
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Baltimore VA Medical Center
Investigators
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Principal Investigator: Brajesh K Lal, MD Baltimore VAMC, University of Maryland School of Medicine
More Information
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Responsible Party: Brajesh K Lal, Professor, Baltimore VA Medical Center
ClinicalTrials.gov Identifier: NCT02189018    
Other Study ID Numbers: HP-00059151
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Keywords provided by Brajesh K Lal, Baltimore VA Medical Center:
Peripheral arterial disease
Endovascular
Exercise
Perfusion
Functional capacity
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Atherosclerosis
 Arteriosclerosis
Vascular Diseases
Cardiovascular Diseases