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 : January 26, 2021

Sponsor:

Information provided by (Responsible Party):

Brajesh K Lal, Baltimore VA Medical Center

Study Description

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 2022
Estimated Study Completion Date :	August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Exercise and Physical Fitness Peripheral Arterial Disease Weight Control

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

Lower extremity perfusion [ Time Frame: 6 months ]
Ankle brachial index and ultrasound quantification of muscle perfusion

Secondary Outcome Measures :

Functional capacity [ Time Frame: 6 months ]
Treadmill exercise testing

Eligibility Criteria

Information from the National Library of Medicine

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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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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:	January 26, 2021
Last Verified:	January 2021

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

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