Status:
COMPLETED
Using Smartphone Sensor Technology to Characterize Ambulatory Patterns of Participants With Peripheral Artery Disease
Lead Sponsor:
University of Minnesota
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
40+ years
Brief Summary
The investigators plan to use smartphone and wearable sensor technology to characterize the activity patterns of participants with peripheral artery disease (PAD) (n=24) participating in a 12-week sup...
Detailed Description
Participants in the proposed study will be current clinical participants in the SET program within Fairview. Participants will have a diagnosis of PAD and be ≥40 years of age (participants are diagnos...
Eligibility Criteria
Inclusion
- Diagnosis of atherosclerotic PAD and referred to hospital-based SET
- Ability to complete an evaluation of physical function and walk on a treadmill
- Resting ankle-brachial index (ABI) of ≤0.90 or stenosis ≥50% in a peripheral vessel or those with lifestyle limiting vascular-related claudication
- Those with a resting ABI of 0.91-0.99 (borderline) who have completed an exercise-ABI assessment with a \>20% drop compared to resting values
- Those with ABI \>1.40 who have had an abnormal toe-brachial index of ≤0.70
Exclusion
- Lower extremity amputation(s) which interfere(s) with walking on the treadmill.
- Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities
- PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis)
- Females who are pregnant
- Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening
- Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure
- Individuals who have had a myocardial infarction within 3 months prior to screening
- Individuals who have had a transient ischemic attack or stroke 3 months prior to screening
- Individuals with uncontrolled hypertension (≥180 systolic or ≥100 diastolic resting blood pressure) during screening
- Poorly controlled diabetes defined as glycated hemoglobin \>12%
- Abnormal results of blood work not conducive to safely participating in an exercise trial (e.g., anemic, electrolyte abnormalities)
- Inability to speak English
- Other clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study
Key Trial Info
Start Date :
November 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04124315
Start Date
November 1 2021
End Date
September 30 2024
Last Update
October 3 2024
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455