Using Smartphone Sensor Technology to Characterize Ambulatory Patterns of Participants With Peripheral Artery Disease

NCT04124315 | Completed

• 1 other identifier: SON-2019-28208
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

peripheral artery disease; accelerometer; smartphone; supervised exercise therapy

Outcome Measures

Primary Outcomes (6)

• Change in The Walking Impairment Questionnaire (WIQ) Distance Subcategory

  In the Walking Impairment Questionnaire distance subcategory, participants are asked to rate the degree of difficulty walking specific distances on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).

  12 weeks

• Change in The Walking Impairment Questionnaire (WIQ) Speed Subcategory

  In the Walking Impairment Questionnaire speed subcategory, participants are asked to rate the degree of difficulty walking one block at specific speeds, ranging from walking slowly to jogging, on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).

  12 weeks

• Change in The Walking Impairment Questionnaire (WIQ) Stair-Climbing Subcategory

  In the Walking Impairment Questionnaire stair-climbing subcategory, participants are asked to rate the degree of difficulty climbing a specified number of stair flights, ranging from 1 to 3 stair flights, on a graded scale of 0 to 4. A score of 0 indicates the inability to climb the flights specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).

  12 weeks

• Change in SF-36 Physical Component Summary

  The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.

  12 weeks

• Change in SF-36 Mental Component Summary

  The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.

  12 weeks

• Peripheral Artery Disease Quality of Life (PADQOL) questionnaire

  PADQOL is a 38-item survey assessing the quality of life of PAD patients. Items are scored on a scale of 1 (strongly agree) to 6 (strongly disagree). Total scores are sums of all 38 items with a range of 38 (normal quality of life) to 228 (quality of life is severely impaired).

  12 weeks

Secondary Outcomes (5)

• Change in Ankle-Brachial Index (ABI) Assessment

  12 weeks

• Change in Six-Minute Walk Test (6-MWT) Maximal Distance

  12 weeks

• Change in Six-Minute Walk Test (6-MWT) Claudication Onset Time

  12 weeks

• Change in Six-Minute Walk Test (6-MWT) Claudication Onset Distance

  12 weeks

• Short Physical Performance Battery (SPPB)

  12 weeks

Study Arms (1)

PAD Patients Completing SET

This single-group study includes patients with peripheral artery disease (PAD) who are completing a physician-prescribed supervised exercise training (SET) program.

Other: Accelerometry; Other: Daynamica app

Interventions

Accelerometry OTHER

Patients will be given accelerometers at this visit and informed on how to use them (e.g., wear on the ankle during waking hours, upright, etc).

PAD Patients Completing SET

Daynamica app OTHER

Participants will be asked to record location/activity on the app in order to characterize activity patterns both inside and outside of the hospital SET setting.

PAD Patients Completing SET

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Accelerometry

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Ryan Mays

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: November 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)