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Clinical Trials/NCT02189018
NCT02189018
Completed
Not Applicable

Activity To Improve Outcomes in Peripheral Arterial Disease

Baltimore VA Medical Center1 site in 1 country208 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Occlusive Disease
Sponsor
Baltimore VA Medical Center
Enrollment
208
Locations
1
Primary Endpoint
Lower extremity perfusion
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
July 4, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brajesh K Lal

Professor

Baltimore VA Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Lower extremity perfusion

Time Frame: 6 months

Ankle brachial index and ultrasound quantification of muscle perfusion

Secondary Outcomes

  • Functional capacity(6 months)

Study Sites (1)

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