Status:
TERMINATED
Home-based Walking Program With Smart Devices
Lead Sponsor:
Dallas VA Medical Center
Conditions:
PAD - Peripheral Arterial Disease
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Intermittent claudication (IC), the most common manifestation of peripheral artery disease (PAD), represents not only a significant detriment in quality of life, but also an increased risk for atheros...
Detailed Description
The study design is that of a prospective randomized study of patients presenting to the vascular surgery and cardiology clinics with symptoms of IC and enrolled in 12-week supervised exercise program...
Eligibility Criteria
Inclusion
- Presence of documented PAD by ABI \<0.90 at rest or ≥20% drop in claudication limited exercise ABI in either limb and one of the following criteria in the corresponding limb:
- i. Prior lower extremity revascularization ii. Known presence of flow-limiting stenosis (≥70%) by clinically indicated angiography, computed tomographic (CT) or magnetic resonance imaging (MRI), or Duplex ultrasonography (DUS)
- Documented diagnosis of intermittent claudication
- Enrollment in supervised exercise therapy through the institutional cardiac rehab program
Exclusion
- Severe cardiac or pulmonary disease that precludes participation in an exercise-based study.
- Severe psychiatric or behavioral illness that precludes study participation
- Inability to provide informed consent
Key Trial Info
Start Date :
August 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04113057
Start Date
August 9 2019
End Date
May 31 2021
Last Update
November 18 2021
Active Locations (1)
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1
Dallas VAMC
Dallas, Texas, United States, 75216