Activity To Improve Outcomes in Peripheral Arterial Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Activity To Improve Outcomes in Peripheral Arterial Disease

Conditions
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Peripheral Arterial Occlusive Disease

Intervention / Treatment
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* Other: Active Exercise
* Other: Neuromuscular electrical stimulation
* Other: Weight loss and active exercise
* Other: Ad lib activity at home


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Ad lib activity at home | Other: Ad lib activity at home<br>* Ad lib activity at home<br>|
| Experimental: Active Exercise<br>Active exercise on treadmill | Other: Active Exercise<br>* Active exercise on a treadmill<br>|
| Experimental: Neuromuscular electrical stimulation<br>Neuromuscular electrical stimulation | Other: Neuromuscular electrical stimulation<br>* Neuromuscular electrical stimulation<br>|
| Experimental: Weight loss and active exercise<br>Weight loss plus active exercise on treadmill | Other: Weight loss and active exercise<br>* Weight loss and active exercise on a treadmill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower extremity perfusion | Ankle brachial index and ultrasound quantification of muscle perfusion | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity | Treadmill exercise testing | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral arterial disease, Endovascular, Exercise, Perfusion, Functional capacity