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Completed

NCT Number: NCT02189018

Activity To Improve Outcomes in Peripheral Arterial Disease

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.

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Key information

Conditions

Peripheral Arterial Occlusive Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Motor Activity Peripheral Arterial Disease Peripheral Arterial Occlusive Disease 1 Peripheral Vascular Diseases Vascular Diseases

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VAMC

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Active Exercise

Other

Active exercise on a treadmill

Neuromuscular electrical stimulation

Other

Neuromuscular electrical stimulation

Weight loss and active exercise

Other

Weight loss and active exercise on a treadmill

Ad lib activity at home

Other

Ad lib activity at home

Primary outcomes

  1. Lower extremity perfusion

    Time frame: 6 months

    Ankle brachial index and ultrasound quantification of muscle perfusion

Secondary outcomes

  1. Functional capacity

    Time frame: 6 months

    Treadmill exercise testing

Sponsors and collaborators

Lead sponsor

Baltimore VA Medical Center

Fed

Registry information

Acronym: ACTION

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2014
Registry last updated
Jul 28, 2023

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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