Activity To Improve Outcomes in Peripheral Arterial Disease

Not Applicable

Completed

• Conditions: Peripheral Arterial Occlusive Disease
• Interventions: Other: Ad lib activity at home; Other: Neuromuscular electrical stimulation; Other: Active Exercise; Other: Weight loss and active exercise

• Registration Number: NCT02189018
• Lead Sponsor: Baltimore VA Medical Center

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.

Study Timeline

• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-14
• Study Start: 2014-08
• Status Verified: 2023-07
• Primary Completion: 2023-07-04
• Study Completion: 2023-07-04
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Ad lib activity at home	Ad lib activity at home
Neuromuscular electrical stimulation	Neuromuscular electrical stimulation	Neuromuscular electrical stimulation
Active Exercise	Active Exercise	Active exercise on treadmill
Weight loss and active exercise	Weight loss and active exercise	Weight loss plus active exercise on treadmill

Primary Outcome Measures

Name	Time	Method
Lower extremity perfusion	6 months	Ankle brachial index and ultrasound quantification of muscle perfusion

Secondary Outcome Measures

Name	Time	Method
Functional capacity	6 months	Treadmill exercise testing

Trial Locations

Locations (1)

Baltimore VAMC; 🇺🇸 Baltimore, Maryland, United States