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Activity To Improve Outcomes in Peripheral Arterial Disease

Activity To Improve Outcomes in Peripheral Arterial Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02189018
Acronym
ACTION
Enrollment
208
Registered
2014-07-14
Start date
2014-08-31
Completion date
2023-07-04
Last updated
2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Occlusive Disease

Keywords

Peripheral arterial disease, Endovascular, Exercise, Perfusion, Functional capacity

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.

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.

Interventions

Active exercise on a treadmill

OTHERNeuromuscular electrical stimulation

Neuromuscular electrical stimulation

OTHERWeight loss and active exercise

Weight loss and active exercise on a treadmill

OTHERAd lib activity at home

Ad lib activity at home

Sponsors

Baltimore VA Medical Center
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lower extremity perfusion6 monthsAnkle brachial index and ultrasound quantification of muscle perfusion

Secondary

MeasureTime frameDescription
Functional capacity6 monthsTreadmill exercise testing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026