Peripheral Artery DiseaseNCT04124315
Using Smartphone Sensor Technology to Characterize Ambulatory Patterns of Participants With Peripheral Artery Disease
An observational study of Peripheral Artery Disease, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Accelerometry and Daynamica app
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Accelerometry, Daynamica app
- Keywords
- peripheral artery disease, accelerometer, smartphone, supervised exercise therapy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometryOther
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).
Daynamica appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Accelerometry; Other: Daynamica app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Nov 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Mays, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124315
- Sponsor's protocol ID
- SON-2019-28208
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2019
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Smartphone Sensor Technology to Characterize Ambulatory Patterns of Participants With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT04124315
- Acronym / sponsor ID
- SON-2019-28208
- Conditions
- Peripheral Artery Disease
- Keywords
- peripheral artery disease, accelerometer, smartphone, supervised exercise therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAD Patients Completing SET | – | Other: Accelerometry, Other: Daynamica appThis single-group study includes patients with peripheral artery disease (PAD) who are completing a physician-prescribed supervised exercise training (SET) program. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelerometryPatients 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 | PAD Patients Completing SET |
| Daynamica appParticipants 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. | Other | PAD Patients Completing SET |
Primary outcome
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).
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).
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).
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.
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.
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).
5 secondary outcomes
Change in Ankle-Brachial Index (ABI) Assessment
Time frame: 12 weeks
Change in Six-Minute Walk Test (6-MWT) Maximal Distance
Time frame: 12 weeks
Change in Six-Minute Walk Test (6-MWT) Claudication Onset Time
Time frame: 12 weeks
Change in Six-Minute Walk Test (6-MWT) Claudication Onset Distance
Time frame: 12 weeks
Short Physical Performance Battery (SPPB)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Mays principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Walking Impairment Questionnaire (WIQ) Distance Subcategory (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.