Activity To Improve Outcomes in Peripheral Arterial Disease (ACTION)

Baltimore VA Medical Center

Status: Completed

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Other: Neuromuscular electrical stimulation; Other: Ad lib activity at home; Other: Active Exercise; Other: Weight loss and active exercise

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02189018

HP-00059151

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 4 patient groups

Control

Active Comparator group

Description:

Ad lib activity at home

Treatment:

Other: Ad lib activity at home

Active Exercise

Experimental group

Description:

Active exercise on treadmill

Treatment:

Other: Active Exercise

Neuromuscular electrical stimulation

Experimental group

Description:

Neuromuscular electrical stimulation

Treatment:

Other: Neuromuscular electrical stimulation

Weight loss and active exercise

Experimental group

Description:

Weight loss plus active exercise on treadmill

Treatment:

Other: Weight loss and active exercise