- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04124315
Using Smartphone Sensor Technology to Characterize Ambulatory Patterns of Participants With Peripheral Artery Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ryan Mays, PhD, MPH, MS
- Phone Number: 612-524-0430
- Email: rjmays@umn.edu
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
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Contact:
- Ryan Mays, PhD, MPH, MS
- Phone Number: 612-625-0430
- Email: rjmays@umn.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in The Walking Impairment Questionnaire (WIQ) Distance Subcategory
Time Frame: 12 weeks
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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).
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12 weeks
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Change in The Walking Impairment Questionnaire (WIQ) Speed Subcategory
Time Frame: 12 weeks
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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).
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12 weeks
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Change in The Walking Impairment Questionnaire (WIQ) Stair-Climbing Subcategory
Time Frame: 12 weeks
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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).
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12 weeks
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Change in SF-36 Physical Component Summary
Time Frame: 12 weeks
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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.
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12 weeks
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Change in SF-36 Mental Component Summary
Time Frame: 12 weeks
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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.
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12 weeks
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Peripheral Artery Disease Quality of Life (PADQOL) questionnaire
Time Frame: 12 weeks
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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).
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Ankle-Brachial Index (ABI) Assessment
Time Frame: 12 weeks
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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.
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12 weeks
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Change in Six-Minute Walk Test (6-MWT) Maximal Distance
Time Frame: 12 weeks
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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.
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12 weeks
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Change in Six-Minute Walk Test (6-MWT) Claudication Onset Time
Time Frame: 12 weeks
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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.
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12 weeks
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Change in Six-Minute Walk Test (6-MWT) Claudication Onset Distance
Time Frame: 12 weeks
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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.
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12 weeks
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Short Physical Performance Battery (SPPB)
Time Frame: 12 weeks
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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. |
12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ryan Mays, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SON-2019-28208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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