Peripheral Artery DiseaseNCT04252950
Community-based Exercise Following Revascularization for PAD
A study testing CB-SET and Revascularization in people with Peripheral Artery Disease, run by University of Minnesota at 1 site in United States.
Trial summary
The primary goal of this clinical trial is to evaluate whether a community-based structured exercise therapy (CB-SET) intervention, which could be accessible and easily disseminated, adds benefit to peripheral artery disease (PAD) patients undergoing revascularization (REVASC) to improve their function and… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- CB-SET and Revascularization
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving Revascularization for aorto-iliac and/or femoral-popliteal disease in at least one limb
- Patients with focal and/or diffuse peripheral artery disease
- Bilateral Revascularization patients will also be included
- Ability to participate in an exercise program
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).
- 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
Show all 13Show fewer
- 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
- Treatment with pentoxifylline or cilostazol for the treatment of claudication 4 weeks prior to screening. Patients can be reconsidered for study inclusion following a 1-month washout period
- Poorly controlled diabetes defined as glycated hemoglobin >12%
- Abnormal results of blood work not conducive to safely participate 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Ryan Mays, PhD, MPH, MS, 612-625-0430, rjmays@umn.edu
About this study
Official title: Community-based Exercise to Improve Physical Functioning and Cardiovascular Health Following Revascularization for Peripheral Artery Disease
The primary goal of this clinical trial is to evaluate whether a community-based structured exercise therapy (CB-SET) intervention, which could be accessible and easily disseminated, adds benefit to peripheral artery disease (PAD) patients undergoing revascularization (REVASC) to improve their function and cardiovascular health.
Read the detailed description
Training (T): Patients assigned to the control group will receive verbal advice to exercise but will receive no other training following their revascularization and outcome assessments. Patients in the intervention group will receive supervised SET in the exercise physiology laboratory for one week (3 sessions) following their REVASC and outcome assessments. Patients will then receive 11 weeks of community-based structured exercise therapy (CB-SET) with training, monitoring, and coaching (TMC) and public health elements at home or in the place of their choosing. Patients will be visited by study staff where walking exercise will take place (1 visit per month, 3 total community visits). The purpose of the initial supervised SET is to educate patients about how to exercise and to address any questions they may have (part of the training component of TMC).
Monitoring (M): Participants will be monitored with a piezoelectric accelerometer over the duration of the 12 total weeks to determine total volume of activity. Participants in both groups will be asked to wear the monitors continuously for 7 days per week over a 10 hour period for each day. This amount of activity monitoring has been successfully used in previous studies (minimal user burden, low profile devices). Additionally, participants in both groups will be reminded to wear the monitor during any walking sessions they perform with intent of exercise. The investigators will determine exercise compliance separately for both groups, and participants in the intervention group will be asked to record details about the CB-SET sessions in a provided exercise log (as conducted in a pilot studies). Data from the piezoelectric accelerometers, which are capable of collecting and storing data for ~6 weeks, will be downloaded and reset at the community visits (1 per month). Control participants will be mailed a new device every 4 weeks (with pre-paid mailers given to control participants for return and subsequent download by staff) or will exchange the device during optional once per month visits to the exercise laboratory. At these visits, control pariticipants will have resting heart rate and blood pressure assessed but no CB-SET program will be applied to ensure these participants receive the standard of care regarding home exercise (upfront advice to walk). Participants in the intervention group will also be given commercially available piezoelectric hip pedometers (Omron), which have an interface to track steps, to monitor their own activity. Weekly phone calls (telehealth) will be conducted by study staff with specific prompting to gain a better evaluation of how much and how often intervention group participants are walking (a feasible process evaluation used in the preliminary studies). Questions included to assist in determining treatment fidelity (ensuring the intervention is delivered as intended) during phone calls and from the exercise log: 1) date and start/end times of walking exercise for each session, 2) number of rest stops needed while walking (and reasons for stopping), 3) questions regarding usage of the piezoelectric accelerometer (instructions for use given to participants), 4) number of steps measured from the hip pedometer, 5) what route the participant chose to use for walking as initially defined by the environmental audit (see section below for more details), and 6) what barriers or facilitators the participant encountered during the session ("Any problems while walking around your neighborhood?"). Additionally, participants will be strongly encouraged to walk with family, friends, and pets to increase walking activity. Participants in both groups will receive a smartphone with an application called Daynamica, which will allow users to indicate and store the location where they complete their community-based activities and to annotate specific exercise sessions or other physical activity episodes. Participants in the control group will receive monthly phone calls only to assess the occurrence of any adverse events and to schedule the optional in-hospital visit.
Coaching (C): The investigators will employ an operational coaching model that will provide training guidance and help addressing local barriers to exercise training in the community setting as well as promoting or reinforcing facilitators for each individual participant in the CB-SET intervention group. This will include: 1) educational print materials and 2) environmental auditing. Educational materials developed by Vascular Cures will include informational outreach activities that have been cited as strategies to promote walking by the Task Force Community Preventive Services. Additionally, in providing control participants with the accelerometers, the investigators are in essence providing them "attention", in addition to the monthly phone calls and optional in-hospital "check-ups" with controls. This attention-control design is meant to provide definitive findings that the substantive aspects of the CB-SET program are efficacious and not the result of simply increased contact time with intervention group participants.
- Conditions
- Peripheral Artery Disease
- Being tested
- CB-SET, Revascularization
- Keywords
- PAD, peripheral artery disease, claudication, revascularization, community-based exercise
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-SETBehavioural
Community-based structured exercise therapy (CB-SET) programs for PAD have potential merit as an alternative to hospital-based SET, as they may provide similar benefit to hospital-based programs but in a convenient location for the exercise to be completed
RevascularizationProcedure or surgery
Endovascular revascularization is a primary treatment option for patients with PAD
| Study group | Role | What they receive |
|---|---|---|
| CB-SET Treatment | Experimental | Participants randomized to this group will receive a community-based structured exercise therapy (CB-SET) along with the standard of care (revascularization) Receives: Behavioral: CB-SET; Procedure: Revascularization |
| Control | Active comparator | Participants randomized to this group will receive standard of care (revascularization) Receives: Procedure: Revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Walking Time (PWT)
Participants will perform graded exercise tests conducted on a treadmill with continuous electrocardiogram monitoring. Participants will run at a constant speed of 2.0 miles/hour, starting at 0% grade. Every 2 min the grade is increased 2% until maximal claudication limits exercise.
PWT (reported in minutes) will be recorded as the maximal time a participant can walk on the treadmill before having to stop due to severe claudication (assessed using the Claudication Symptom Rating Scale which ranges from 1-5 with 1=no pain, 2=onset claudication, 3=mild, 4=moderate, and 5=severe).
Measured: Baseline, 12 weeks
Secondary outcomes (17)
Change in Claudication Onset Time (COT)
Participants will perform graded exercise tests conducted on a treadmill with continuous electrocardiogram monitoring. Participants will run at a constant speed of 2.0 miles/hour, starting at 0% grade. Every 2 min the grade is increased 2% until maximal claudication limits exercise.
COT (reported in minutes) will be obtained with the patient pointing to the pain scale at the initial presentation of leg pain (assessed using the Claudication Symptom Rating Scale which ranges from 1-5 with 1=no pain, 2=onset claudication, 3=mild, 4=moderate, and 5=severe).
Measured: Baseline, 12 weeks
Change in VO2max
VO2 max is the maximum rate of oxygen consumption measured during incremental exercise. Participants will perform graded exercise tests conducted on a treadmill while oxygen consumption is measured and recorded. Maximum rate of oxygen consumption during exercise will be reported in mL/kg*min-1.
Measured: Baseline, 12 weeks
Total Volume of Exercise
Patients will be monitored with a piezoelectric accelerometer over the duration of the 12 total weeks to determine total volume of activity. The average minutes of activity per day will be reported.
Measured: 12 weeks
Adherence to Exercise
Participants will be given a StepWatch accelerometer. Exercise compliance will be calculated for PAD participants as the total number of completed sessions divided by 36 (3 sessions/week for 12 weeks).
Measured: 12 weeks
Change in 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: Baseline, 12 weeks
Change in 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: Baseline, 12 weeks
Change in 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: Baseline, 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: Baseline, 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: Baseline, 12 weeks
Change in PADQOL Factor 1: Social Relationships and Interactions
The Peripheral Artery Disease Quality of Life (PADQOL) is a 38-item survey assessing 5 quality of life factors of PAD patients: Social relationships and interactions; Self-concept and feelings; Symptoms and limitations in physical functioning; Fear and uncertainty; and Positive adaptation. Items are scored on a scale of 1 (strongly agree) to 6 (strongly disagree). 5 factor scores are calculated by summing all items in that factor. These factor scores are labeled F1- F5. The factor totals are then transformed into percentiles using the formula: [(sum of scores on factor items - # of factor items) / (5 * # of factor items)]*100 = factor percentile. Total factor scores range from 0 to 100 with higher scores indicating greater quality of life.
Measured: Baseline, 12 weeks
Change in PADQOL Factor 2: Self-concept and Feelings
The Peripheral Artery Disease Quality of Life (PADQOL) is a 38-item survey assessing 5 quality of life factors of PAD patients: Social relationships and interactions; Self-concept and feelings; Symptoms and limitations in physical functioning; Fear and uncertainty; and Positive adaptation. Items are scored on a scale of 1 (strongly agree) to 6 (strongly disagree). 5 factor scores are calculated by summing all items in that factor. These factor scores are labeled F1- F5. The factor totals are then transformed into percentiles using the formula: [(sum of scores on factor items - # of factor items) / (5 * # of factor items)]*100 = factor percentile. Total factor scores range from 0 to 100 with higher scores indicating greater quality of life.
Measured: Baseline, 12 weeks
Change in PADQOL Factor 3: Symptoms and Limitations in Physical Functioning
The Peripheral Artery Disease Quality of Life (PADQOL) is a 38-item survey assessing 5 quality of life factors of PAD patients: Social relationships and interactions; Self-concept and feelings; Symptoms and limitations in physical functioning; Fear and uncertainty; and Positive adaptation. Items are scored on a scale of 1 (strongly agree) to 6 (strongly disagree). 5 factor scores are calculated by summing all items in that factor. These factor scores are labeled F1- F5. The factor totals are then transformed into percentiles using the formula: [(sum of scores on factor items - # of factor items) / (5 * # of factor items)]*100 = factor percentile. Total factor scores range from 0 to 100 with higher scores indicating greater quality of life.
Measured: Baseline, 12 weeks
Change in PADQOL Factor 4: Fear and Uncertainty
The Peripheral Artery Disease Quality of Life (PADQOL) is a 38-item survey assessing 5 quality of life factors of PAD patients: Social relationships and interactions; Self-concept and feelings; Symptoms and limitations in physical functioning; Fear and uncertainty; and Positive adaptation. Items are scored on a scale of 1 (strongly agree) to 6 (strongly disagree). 5 factor scores are calculated by summing all items in that factor. These factor scores are labeled F1- F5. The factor totals are then transformed into percentiles using the formula: [(sum of scores on factor items - # of factor items) / (5 * # of factor items)]*100 = factor percentile. Total factor scores range from 0 to 100 with higher scores indicating greater quality of life.
Measured: Baseline, 12 weeks
Change in PADQOL Factor 5: Positive Adaptation
The Peripheral Artery Disease Quality of Life (PADQOL) is a 38-item survey assessing 5 quality of life factors of PAD patients: Social relationships and interactions; Self-concept and feelings; Symptoms and limitations in physical functioning; Fear and uncertainty; and Positive adaptation. Items are scored on a scale of 1 (strongly agree) to 6 (strongly disagree). 5 factor scores are calculated by summing all items in that factor. These factor scores are labeled F1- F5. The factor totals are then transformed into percentiles using the formula: [(sum of scores on factor items - # of factor items) / (5 * # of factor items)]*100 = factor percentile. Total factor scores range from 0 to 100 with higher scores indicating greater quality of life.
Measured: Baseline, 12 weeks
Change in PADQOL Question 21: Job/Work
The Peripheral Artery Disease Quality of Life (PADQOL) is a 38-item survey assessing 5 quality of life factors of PAD patients: Social relationships and interactions; Self-concept and feelings; Symptoms and limitations in physical functioning; Fear and uncertainty; and Positive adaptation. Items are scored on a scale of 1 (strongly agree) to 6 (strongly disagree). 5 factor scores are calculated. 3 items (Q21, Q23, and Q24) are not included in any of the factors but are instead reported individually. The raw score of question 21 is transformed using the following formula: [(Q21 - 1) / 5] * 100 = JOB percentile. Final scores range from 0 to 100 with higher scores indicating better quality of life.
Measured: Baseline, 12 weeks
Change in PADQOL Question 23: Sex
The Peripheral Artery Disease Quality of Life (PADQOL) is a 38-item survey assessing 5 quality of life factors of PAD patients: Social relationships and interactions; Self-concept and feelings; Symptoms and limitations in physical functioning; Fear and uncertainty; and Positive adaptation. Items are scored on a scale of 1 (strongly agree) to 6 (strongly disagree). 5 factor scores are calculated. 3 items (Q21, Q23, and Q24) are not included in any of the factors but are instead reported individually. The raw score of question 23 is reserve scored and then transformed using the following formula: [(RQ23 - 1) / 5] * 100 = SEX percentile. Final scores range from 0 to 100 with higher scores indicating better quality of life.
Measured: Baseline, 12 weeks
Change in PADQOL Question 24: Intimate Relationships
The Peripheral Artery Disease Quality of Life (PADQOL) is a 38-item survey assessing 5 quality of life factors of PAD patients: Social relationships and interactions; Self-concept and feelings; Symptoms and limitations in physical functioning; Fear and uncertainty; and Positive adaptation. Items are scored on a scale of 1 (strongly agree) to 6 (strongly disagree). 5 factor scores are calculated. 3 items (Q21, Q23, and Q24) are not included in any of the factors but are instead reported individually. The raw score of question 24 is reserve scored and then transformed using the following formula: [(RQ24 - 1) / 5] * 100 = IR percentile. Final scores range from 0 to 100 with higher scores indicating better quality of life.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start8 Apr 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Mays, PhD, MPH, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252950
- Sponsor's protocol ID
- SON-2020-28532
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2020
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Exercise to Improve Physical Functioning and Cardiovascular Health Following Revascularization for Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT04252950
- Acronym / sponsor ID
- SON-2020-28532
- Conditions
- Peripheral Artery Disease
- Keywords
- PAD, peripheral artery disease, claudication, revascularization, community-based exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Feb 2020 (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 primary goal of this clinical trial is to evaluate whether a community-based structured exercise therapy (CB-SET) intervention, which could be accessible and easily disseminated, adds benefit to peripheral artery disease (PAD) patients undergoing revascularization (REVASC) to improve their function and cardiovascular health.
Detailed description
Training (T): Patients assigned to the control group will receive verbal advice to exercise but will receive no other training following their revascularization and outcome assessments. Patients in the intervention group will receive supervised SET in the exercise physiology laboratory for one week (3 sessions) following their REVASC and outcome assessments. Patients will then receive 11 weeks of community-based structured exercise therapy (CB-SET) with training, monitoring, and coaching (TMC) and public health elements at home or in the place of their choosing. Patients will be visited by study staff where walking exercise will take place (1 visit per month, 3 total community visits). The purpose of the initial supervised SET is to educate patients about how to exercise and to address any questions they may have (part of the training component of TMC).
Monitoring (M): Participants will be monitored with a piezoelectric accelerometer over the duration of the 12 total weeks to determine total volume of activity. Participants in both groups will be asked to wear the monitors continuously for 7 days per week over a 10 hour period for each day. This amount of activity monitoring has been successfully used in previous studies (minimal user burden, low profile devices). Additionally, participants in both groups will be reminded to wear the monitor during any walking sessions they perform with intent of exercise. The investigators will determine exercise compliance separately for both groups, and participants in the intervention group will be asked to record details about the CB-SET sessions in a provided exercise log (as conducted in a pilot studies). Data from the piezoelectric accelerometers, which are capable of collecting and storing data for ~6 weeks, will be downloaded and reset at the community visits (1 per month). Control participants will be mailed a new device every 4 weeks (with pre-paid mailers given to control participants for return and subsequent download by staff) or will exchange the device during optional once per month visits to the exercise laboratory. At these visits, control pariticipants will have resting heart rate and blood pressure assessed but no CB-SET program will be applied to ensure these participants receive the standard of care regarding home exercise (upfront advice to walk). Participants in the intervention group will also be given commercially available piezoelectric hip pedometers (Omron), which have an interface to track steps, to monitor their own activity. Weekly phone calls (telehealth) will be conducted by study staff with specific prompting to gain a better evaluation of how much and how often intervention group participants are walking (a feasible process evaluation used in the preliminary studies). Questions included to assist in determining treatment fidelity (ensuring the intervention is delivered as intended) during phone calls and from the exercise log: 1) date and start/end times of walking exercise for each session, 2) number of rest stops needed while walking (and reasons for stopping), 3) questions regarding usage of the piezoelectric accelerometer (instructions for use given to participants), 4) number of steps measured from the hip pedometer, 5) what route the participant chose to use for walking as initially defined by the environmental audit (see section below for more details), and 6) what barriers or facilitators the participant encountered during the session ("Any problems while walking around your neighborhood?"). Additionally, participants will be strongly encouraged to walk with family, friends, and pets to increase walking activity. Participants in both groups will receive a smartphone with an application called Daynamica, which will allow users to indicate and store the location where they complete their community-based activities and to annotate specific exercise sessions or other physical activity episodes. Participants in the control group will receive monthly phone calls only to assess the occurrence of any adverse events and to schedule the optional in-hospital visit.
Coaching (C): The investigators will employ an operational coaching model that will provide training guidance and help addressing local barriers to exercise training in the community setting as well as promoting or reinforcing facilitators for each individual participant in the CB-SET intervention group. This will include: 1) educational print materials and 2) environmental auditing. Educational materials developed by Vascular Cures will include informational outreach activities that have been cited as strategies to promote walking by the Task Force Community Preventive Services. Additionally, in providing control participants with the accelerometers, the investigators are in essence providing them "attention", in addition to the monthly phone calls and optional in-hospital "check-ups" with controls. This attention-control design is meant to provide definitive findings that the substantive aspects of the CB-SET program are efficacious and not the result of simply increased contact time with intervention group participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CB-SET Treatment | Experimental | Behavioral: CB-SET, Procedure: RevascularizationParticipants randomized to this group will receive a community-based structured exercise therapy (CB-SET) along with the standard of care (revascularization) |
| Control | Active comparator | Procedure: RevascularizationParticipants randomized to this group will receive standard of care (revascularization) |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients receiving Revascularization for aorto-iliac and/or femoral-popliteal disease in at least one limb
- Patients with focal and/or diffuse peripheral artery disease
- Bilateral Revascularization patients will also be included
- Ability to participate in an exercise program
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).
- 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
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 |
|---|---|---|
| CB-SETCommunity-based structured exercise therapy (CB-SET) programs for PAD have potential merit as an alternative to hospital-based SET, as they may provide similar benefit to hospital-based programs but in a convenient location for the exercise to be completed | Behavioural | CB-SET Treatment |
| RevascularizationEndovascular revascularization is a primary treatment option for patients with PAD | Procedure or surgery | CB-SET Treatment, Control |
Primary outcome
Change in Peak Walking Time (PWT)
Time frame: Baseline, 12 weeks
Participants will perform graded exercise tests conducted on a treadmill with continuous electrocardiogram monitoring. Participants will run at a constant speed of 2.0 miles/hour, starting at 0% grade. Every 2 min the grade is increased 2% until maximal claudication limits exercise. PWT (reported in minutes) will be recorded as the maximal time a participant can walk on the treadmill before having to stop due to severe claudication (assessed using the Claudication Symptom Rating Scale which ranges from 1-5 with 1=no pain, 2=onset claudication, 3=mild, 4=moderate, and 5=severe).
17 secondary outcomes
Change in Claudication Onset Time (COT)
Time frame: Baseline, 12 weeks
Change in VO2max
Time frame: Baseline, 12 weeks
Total Volume of Exercise
Time frame: 12 weeks
Adherence to Exercise
Time frame: 12 weeks
Change in Walking Impairment Questionnaire (WIQ) Distance Subcategory
Time frame: Baseline, 12 weeks
Change in Walking Impairment Questionnaire (WIQ) Speed Subcategory
Time frame: Baseline, 12 weeks
Change in Walking Impairment Questionnaire (WIQ) Stair-Climbing Subcategory
Time frame: Baseline, 12 weeks
Change in SF-36 Physical Component Summary
Time frame: Baseline, 12 weeks
Change in SF-36 Mental Component Summary
Time frame: Baseline, 12 weeks
Change in PADQOL Factor 1: Social Relationships and Interactions
Time frame: Baseline, 12 weeks
Change in PADQOL Factor 2: Self-concept and Feelings
Time frame: Baseline, 12 weeks
Change in PADQOL Factor 3: Symptoms and Limitations in Physical Functioning
Time frame: Baseline, 12 weeks
Change in PADQOL Factor 4: Fear and Uncertainty
Time frame: Baseline, 12 weeks
Change in PADQOL Factor 5: Positive Adaptation
Time frame: Baseline, 12 weeks
Change in PADQOL Question 21: Job/Work
Time frame: Baseline, 12 weeks
Change in PADQOL Question 23: Sex
Time frame: Baseline, 12 weeks
Change in PADQOL Question 24: Intimate Relationships
Time frame: Baseline, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
Ryan Mays, PhD, MPH, MS 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?
A study testing CB-SET and Revascularization in people with 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 4 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Mays, PhD, MPH, MS (612-625-0430, rjmays@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Walking Time (PWT) (time frame: Baseline, 12 weeks). 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 9 Sep 2026.