Clinical trial NCT04124315: Using Smartphone Sensor Technology to Characterize Ambulatory Patterns of Participants With Peripheral Artery Disease
Official title: Using Smartphone Sensor Technology to Characterize Ambulatory Patterns of Participants With Peripheral Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: peripheral artery disease
accelerometer
smartphone
supervised exercise therapy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: PAD patients completing exercise training in the cardiac rehab programs in the Fairview Health System. The five Fairview hospital-based sites are located at urban and rural sites within and outside of the Twin Cities metropolitan area: Riverside (Minneapolis/St. Paul, MN), Southdale (Edina, MN), Ridges (Burnsville, MN), Lakes (Wyoming, MN), and Northland (Princeton, MN).

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 supervised exercise training (SET) program, and incorporate the resulting data into a web-based dashboard for participants and study staff.

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 diagnosed before they are referred to the SET program). Rate limiting comorbidities not associated with vascular disease (e.g., severe chronic obstructive pulmonary disease) will be exclusionary (for example). Age, sex, race, ethnicity, educational status, and smoking status at baseline will be recorded from cardiac rehabilitation intake forms. Eligible participants will be identified by study staff reviewing electronic medical records of patients who are enrolling into the SET program. University of Minnesota staff will travel to the urban and rural clinical rehabilitation sites to obtain informed consent at the participants first SET visit. They will then provide participants instructions and training for how to use the smartphone and app.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in The Walking Impairment Questionnaire (WIQ) Distance Subcategory
timeFrame: 12 weeks
measure: Change in The Walking Impairment Questionnaire (WIQ) Speed Subcategory
timeFrame: 12 weeks
measure: Change in The Walking Impairment Questionnaire (WIQ) Stair-Climbing Subcategory
timeFrame: 12 weeks
measure: Change in SF-36 Physical Component Summary
timeFrame: 12 weeks
measure: Change in SF-36 Mental Component Summary
timeFrame: 12 weeks
measure: Peripheral Artery Disease Quality of Life (PADQOL) questionnaire
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Ankle-Brachial Index (ABI) Assessment
timeFrame: 12 weeks
measure: Change in Six-Minute Walk Test (6-MWT) Maximal Distance
timeFrame: 12 weeks
measure: Change in Six-Minute Walk Test (6-MWT) Claudication Onset Time
timeFrame: 12 weeks
measure: Change in Six-Minute Walk Test (6-MWT) Claudication Onset Distance
timeFrame: 12 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ryan Mays
role: PRINCIPAL_INVESTIGATOR
References: