Smartstep Smartphone PAD (SMARTSTEP)
Peripheral Arterial Disease
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Smartphone, Exercise, Functional capacity
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
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
Sites / Locations
- Grady Health System (non-CRN)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Smartphone-enabled structured exercise therapy (SE-SET)
Standard exercise therapy
This arm involves a smartphone app Movn - rehabilitation platform based on MULTIFIT, a case-management system for secondary prevention and patient surveillance after acute MI. The key features of the smartphone app include daily reminders to exercise, virtual diary for patients to enter data on exercise sessions, two-way secure messaging with the health coach, and educational videos on heart and vascular health.
Self-directed, unsupervised exercise as prescribed by the patient's physician.