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

• ClinicalTrials.gov Identifier: NCT04124315
• Recruitment Status: Recruiting
• First Posted: October 11, 2019
• Last Update Posted: February 28, 2022
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment
Peripheral Artery Disease	Other: Accelerometry; Other: Daynamica app

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 24 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Using Smartphone Sensor Technology to Characterize Ambulatory Patterns of Participants With Peripheral Artery Disease
• Actual Study Start Date: November 1, 2021
• Estimated Primary Completion Date: November 30, 2022
• Estimated Study Completion Date: November 30, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; 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).; Other: Daynamica app; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in The Walking Impairment Questionnaire (WIQ) Distance Subcategory [ Time Frame: 12 weeks ]
   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).
2. Change in The Walking Impairment Questionnaire (WIQ) Speed Subcategory [ Time Frame: 12 weeks ]
   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).
3. Change in The Walking Impairment Questionnaire (WIQ) Stair-Climbing Subcategory [ Time Frame: 12 weeks ]
   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).
4. Change in SF-36 Physical Component Summary [ Time Frame: 12 weeks ]
   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.
5. Change in SF-36 Mental Component Summary [ Time Frame: 12 weeks ]
   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.
6. Peripheral Artery Disease Quality of Life (PADQOL) questionnaire [ Time Frame: 12 weeks ]
   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).

Secondary Outcome Measures :

1. Change in Ankle-Brachial Index (ABI) Assessment [ Time Frame: 12 weeks ]
   The Ankle Brachial Index (ABI) calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure at the arm. Values between 1.0 and 1.4 are considered clinically normal while lower scores indicate greater progression of vascular disease with scores less than 0.5 indicating severe PAD.
2. Change in Six-Minute Walk Test (6-MWT) Maximal Distance [ Time Frame: 12 weeks ]
   Participants will walk in a 50-foot corridor at the hospital. Maximal walking distance achieved in 6 minutes is recorded in feet. Decreased walking distance indicates increased impairment due to PAD.
3. Change in Six-Minute Walk Test (6-MWT) Claudication Onset Time [ Time Frame: 12 weeks ]
   Participants will walk in a 50-foot corridor at the hospital. Claudication onset time is recorded in seconds. Decreased time for claudication onset indicates increased impairment due to PAD.
4. Change in Six-Minute Walk Test (6-MWT) Claudication Onset Distance [ Time Frame: 12 weeks ]
   Participants will walk in a 50-foot corridor at the hospital. Claudication onset distance is recorded in feet. Decreased walking distance before claudication onset indicates increased impairment due to PAD.
5. Short Physical Performance Battery (SPPB) [ Time Frame: 12 weeks ]

   The SPPB is a group of measures including balance, gait speed, and chair stand. In the balance sub test, patients are awarded points for holding a position for a longer period of time. The balance sub score is a summed value ranging from 0 to 4.

   In the gait speed sub test, patients are awarded points for walking a set distance in less time. The gait speed sub score ranges from 1 (time > 8.7 sec) to 4 (time < 4.82 sec) for a 4-meter distance and 1 (time > 6.52 sec) to 4 (time < 3.62 sec) for the 3-meter distance.

   In the chair stand sub test, patients are asked to stand from a sitting position. The chair stand sub score ranges from 0 (unable to complete 5 chair stands or completes stand in >60 sec) to 4 (chair stand time is 11.19 sec of less).

   The SPPB total score is an unweighted sum of the 3 sub scores, with possible total scores ranging from 1 to 12. Higher scores indicate better function.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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).

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

Contacts and Locations

Contacts

Contact: Ryan Mays, PhD, MPH, MS; 612-524-0430; rjmays@umn.edu

Locations

United States, Minnesota

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55455

Contact: Ryan Mays, PhD, MPH, MS 612-625-0430 rjmays@umn.edu

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Ryan Mays; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04124315
• Other Study ID Numbers: SON-2019-28208
• First Posted: October 11, 2019
• Last Update Posted: February 28, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota:

peripheral artery disease; accelerometer; smartphone; supervised exercise therapy

Additional relevant MeSH terms:

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