An observational study in Peripheral Artery Disease, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by University of Minnesota · Observational
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.
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 19 is below the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
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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).
Exclusion Criteria:
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
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).
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 12 weeks
Change in Ankle-Brachial Index (ABI) Assessment
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.
Time frame: 12 weeks
Change in Six-Minute Walk Test (6-MWT) Maximal Distance
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.
Time frame: 12 weeks
Change in Six-Minute Walk Test (6-MWT) Claudication Onset Time
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.
Time frame: 12 weeks
Change in Six-Minute Walk Test (6-MWT) Claudication Onset Distance
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.
Time frame: 12 weeks
Short Physical Performance Battery (SPPB)
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.
Time frame: 12 weeks
Plan to share: No
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