Status:
COMPLETED
Smartstep Smartphone PAD
Lead Sponsor:
Emory University
Collaborating Sponsors:
Woodruff Health Sciences Center Foundation
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).
Detailed Description
Structured exercise therapy is a first line treatment for symptomatic peripheral artery disease, but compliance is poor. Coaching programs may help but requires significant resources. Smartphone progr...
Eligibility Criteria
Inclusion
- Clinically stable intermittent claudication
- Able to give informed consent
- Age 18-89 years
- And one of the following:
- ABI \< 0.9 after 10 minutes of rest OR
- For subjects with an ABI of \>1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of \< 0.70 must be obtained for subject qualification. If ABI is \> 0.9 to 1.0, a reduction of 20% in ABI must be measured within 1 minute of treadmill testing.
Exclusion
- Life-threatening process including:
- Sepsis
- Critical limb ischemia (Rutherford class 4-6)
- Unstable angina
- Active malignancy with life expectancy \< 6 months
- Severe NYHA Class IV heart failure
- Condition other than PAD that limits walking before claudication onset
- This includes, but is not limited to:
- Severe angina or dyspnea
- Arthritis
- Muscle weakness/pain
- Active behavioral conditions such as uncontrolled schizophrenia or illicit drug addiction that, in the opinion of the study team, will interfere with active participation
- Inability to attend study visits
Key Trial Info
Start Date :
August 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03479255
Start Date
August 24 2018
End Date
February 20 2025
Last Update
March 13 2025
Active Locations (1)
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1
Grady Health System (non-CRN)
Atlanta, Georgia, United States, 30303