Peripheral Artery DiseaseINTERCEDENCT03871075
Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease
A study testing intermittent pneumatic compression, exercise and Health Education in people with Peripheral Artery Disease, run by Northwestern University at 4 sites in United States.
Trial summary
The INTERCEDE randomized trial will establish whether six-months of intermittent pneumatic compression combined with walking exercise improves walking endurance at six-month follow-up, compared to walking exercise + sham compression therapy, in people with lower extremity peripheral artery disease (PAD). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- intermittent pneumatic compression, exercise and Health Education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Jan 2019to 17 Sep 2026
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants will have PAD. PAD will be defined as follows: first, an ankle-brachial index (ABI) < or = 0.90 at the baseline study visit is an inclusion criterion for PAD. Second, potential participants with an ABI >0.90 who have vascular laboratory evidence of PAD. Vascular laboratory evidence consists of objective evidence of PAD, including toe brachial index (TBI) < or = 0.70, Duplex measure showing 70% stenosis or greater, or ABI values < 0.90. Abnormal waveforms or pulse volume recordings alone from a non-invasive vascular laboratory test will not be sufficient for enrollment. Third, potential participants with an ABI >0.90 who have angiographic evidence of PAD consisting of a stenosis of 70% or greater in a lower extremity artery.
Who cannot join
- Above- or below-knee amputation.
- Critical limb ischemia or ABI < 0.30 in the setting of ischemic symptoms at rest or physical examination findings consistent with critical limb ischemia. Some potential participants with symptoms or signs of critical limb ischemia may be excluded at the principal investigator's discretion if the ABI is 0.30 or higher.
- Wheelchair-bound.
- Current foot ulcer on bottom of foot.
- Walking is primarily limited by a symptom other than PAD.
- Failure to successfully complete the study run-in.
Show all 20Show fewer
- Major surgery, revascularization, or orthopedic surgery in the past 3 months or planned in the next 12 months.
- Major medical illness including Parkinson's Disease, lung disease requiring oxygen, cancer requiring treatment in the previous two years, or life-threatening illness with a life expectancy of less than six months. Participants who only use oxygen at night will be potentially eligible. [NOTE: potential participants treated for cancer in the past two years may still qualify if they have had treatment for early stage cancer in the past two years and the prognosis is excellent. Potential participants treated for basal cell or squamous cell skin cancer will not be excluded.]
- Already exercising at a level consistent with exercise intervention. Current or recent participation in exercise rehabilitation (within the past three months).
- Recently diagnosed (within the past three months) with acute lower extremity deep venous thrombosis, pulmonary embolism, or severe heart failure (i.e. New York Heart Association (NYHA) Class III or IV).
- Mini-Mental Status Examination (MMSE) score <23 or dementia.
- Participation in or completion of a clinical trial in the previous three months.
- Non-English speaking.
- Increase in angina in the past month, angina at rest, or abnormal baseline treadmill stress test. Potential participants may become eligible after an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing (such as a stress test with imaging or a coronary angiogram) from a test performed with their own physician and if they do not have symptoms of unstable angina. The evidence of absent coronary ischemia, based on an imaging stress test or coronary angiogram, must have been performed within the previous year.
- Ongoing infection of the toes, foot, or lower extremity.
- Potential participants who started on cilostazol within the last three months. They may be evaluated for eligibility once three months have passed since beginning cilostazol.
- Significant peripheral edema, defined as 3+ or greater edema severity, as determined by the principal investigator.
- BMI >45 kg/M2
- Significant visual impairment that interferes with walking.
- In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Henry Ford Health
Detroit, Michigan, 48202
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease: The INTERCEDE TRIAL
The INTERCEDE randomized trial will establish whether six-months of intermittent pneumatic compression combined with walking exercise improves walking endurance at six-month follow-up, compared to walking exercise + sham compression therapy, in people with lower extremity peripheral artery disease (PAD). The INTERCEDE trial will also determine whether intermittent pneumatic compression therapy improves walking endurance at 6-month follow-up, compared to a sham compression therapy. The trial will also determine whether benefits of intermittent pneumatic compression persist after intermittent pneumatic compression treatment is completed.
Read the detailed description
Walking exercise is first-line therapy for PAD. However, many PAD patients are unable or unwilling to exercise. Therefore, in people with PAD, the investigators will determine whether intermittent pneumatic compression augments the benefits of exercise and whether intermittent pneumatic compression alone improves walking performance compared to sham control. The investigators will conduct a randomized trial (2 x 2 factorial design) of 230 PAD participants randomized to one of four groups: Group A: intermittent pneumatic compression + exercise; Group B: intermittent pneumatic compression+ "no exercise" control; Group C: sham control + exercise; and Group D: sham control + "no exercise" control. The intermittent pneumatic compression and sham interventions will be delivered for six months. The primary outcome is change in six-minute walk distance at 6-month follow-up. In secondary aims, the investigators will determine whether the benefits of intermittent pneumatic compression persist even after intermittent pneumatic compression is discontinued and delineate mechanisms by which intermittent pneumatic compression affects walking performance, by measuring changes in MRI-measured calf muscle perfusion and physical activity. The investigators will determine whether intermittent pneumatic compression improves systemic endothelial function, by measuring changes in brachial artery flow-mediated dilation (FMD).
- Conditions
- Peripheral Artery Disease
- Being tested
- intermittent pneumatic compression, exercise, Sham device, Health Education
- Keywords
- peripheral arterial disease, Peripheral Artery Disease, PAD, exercise, Intermittent claudication
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent pneumatic compressionDevice
Also called IPC
Intermittent pneumatic compression is a non-invasive intervention, consisting of an air pump inside inflatable cuffs that are wrapped around the feet, ankles, and calves. The cuffs rapidly inflate to a pressure of 120 mm Hg, which is sustained for three seconds, followed by rapid deflation. Participants will be asked to wear the device for two hours daily. The device will inflate 180 times/hour.
exerciseBehavioural
Participants will be asked to walk for exercise five days/week, working up to 50 minutes of exercise per day. The intervention includes a) group meetings at the medical center with the coach and other PAD participants; b) regularly scheduled individual telephone check-in by the coach c) weekly remote monitoring by the coach; d) use of the activity monitor to monitor exercise intensity and duration.
Sham deviceDevice
The sham control device is a non-invasive intervention, consisting of an air pump inside inflatable cuffs that are wrapped around the feet, ankles, and calves. The cuffs rapidly inflate to a pressure of 25 mm Hg, which is sustained for three seconds, followed by rapid deflation. Participants will be asked to wear the device for two hours daily. The device will inflate 180 times/hour.
Health EducationBehavioural
Participants attend health-education lectures and receive telephone calls at the same frequency as the exercise group. On-site lectures are delivered by faculty and staff at the medical center. Telephone calls review health-related handouts from the NIA website that are mailed in advance of the telephone call. Content does not include exercise information.
| Study group | Role | What they receive |
|---|---|---|
| IPC + exercise | Experimental | Participants will be asked to wear the intermittent pneumatic compression device for up to three hours daily. They will be helped to engage in home-based walking exercise therapy. Receives: Device: intermittent pneumatic compression; Behavioral: exercise |
| IPC + "no exercise" control | Experimental | Participants will be asked to wear the intermittent pneumatic compression device for up to three hours daily. They will be asked to participate in an educational/informational intervention consisting of an attention control intervention Receives: Device: intermittent pneumatic compression; Behavioral: Health Education |
| sham control + exercise | Active comparator | Participants will be asked to wear a sham intermittent pneumatic compression device for up to three hours daily. The sham device inflates at the same frequency, but to a much lower systolic pressure, compared to the therapeutic pneumatic compression device. Participants in this group will be helped to engage in home-based walking exercise therapy. Receives: Behavioral: exercise; Device: Sham device |
| sham control + "no exercise" control | Active comparator | Participants will be asked to wear a sham intermittent pneumatic compression device for up to three hours daily. The sham device inflates at the same frequency, but to a much lower systolic pressure, compared to the therapeutic pneumatic compression device. Participants will be asked to participate in an educational/informational intervention, designed as an attention control group. Receives: Device: Sham device; Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk distance (intermittent pneumatic compression therapy + exercise v. exercise only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression combined with exercise improves the 6-minute walk at 6-month follow-up compared to exercise alone.
Measured: Baseline to 6-month follow-up
Six-minute walk distance (intermittent pneumatic compression therapy alone (without exercise) vs. sham alone (without exercise)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone (without exercise) improves the 6-minute walk at 6-month follow-up, compared to the sham control alone (without exercise).
Measured: Baseline to 6-month follow-up
Secondary outcomes (14)
Six-minute walk distance (intermittent pneumatic compression therapy + exercise v. exercise only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves the six-minute walk at 12-month follow-up, 6 months after the intermittent pneumatic compression therapy intervention is completed, compared to exercise alone.
Measured: Baseline to 12-month follow-up
Six-minute walk distance (IPC only v. sham only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves the six-minute walk distance at 12-month follow-up, 6 months after the intermittent pneumatic compression therapy intervention is completed, compared to the sham control.
Measured: Baseline to 12-month follow-up
Calf muscle perfusion (intermittent pneumatic compression therapy + exercise v. exercise only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves calf muscle perfusion at 6-month follow-up, compared to exercise alone.
Measured: Baseline to 6-month follow-up
Brachial artery FMD (intermittent pneumatic compression therapy + exercise v. exercise only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves brachial artery FMD at 6-month follow-up, compared to exercise alone.
Measured: Baseline to 6-month follow-up
Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy + exercise v. exercise only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves physical activity measured by Actigraph activity monitor at 6-month follow-up, compared to exercise alone.
Measured: Baseline to 6-month follow-up
Calf muscle perfusion (intermittent pneumatic compression therapy + exercise v. exercise only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves calf muscle perfusion at 12-month follow-up, compared to exercise alone.
Measured: Baseline to 12-month follow-up
Brachial artery FMD (intermittent pneumatic compression therapy + exercise v. exercise only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves brachial artery FMD at 12-month follow-up, compared to exercise alone.
Measured: Baseline to 12-month follow-up
Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy + exercise v. exercise only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves physical activity measured by Actigraph activity monitor at 12-month follow-up, compared to exercise alone.
Measured: Baseline to 12-month follow-up
Calf muscle perfusion (intermittent pneumatic compression therapy only v. sham only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves calf muscle perfusion at 6-month follow-up, compared to the sham control.
Measured: Baseline to 6-month follow-up
Brachial artery FMD (intermittent pneumatic compression therapy only v. sham only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves brachial artery FMD at 6-month follow-up, compared to the sham control.
Measured: Baseline to 6-month follow-up
Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy only v. sham only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves physical activity measured by Actigraph activity monitor at 6-month follow-up, compared to the sham control.
Measured: Baseline to 6-month follow-up
Calf muscle perfusion (intermittent pneumatic compression therapy only v. sham only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves calf muscle perfusion at 12-month follow-up, compared to the sham control.
Measured: Baseline to 12-month follow-up
Brachial artery FMD (intermittent pneumatic compression therapy only v. sham only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves brachial artery FMD at 12-month follow-up, compared to the sham control.
Measured: Baseline to 12-month follow-up
Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy only v. sham only)
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves physical activity measured by Actigraph activity monitor at 12-month follow-up, compared to the sham control.
Measured: Baseline to 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start2 Jan 2019
- Primary completion28 Aug 2026
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mary McDermott, Northwestern University
- Investigators
- Mary McDermott, MD, Principal investigator, Northwestern Universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871075
- Sponsor's protocol ID
- STU00208245
- Other IDs
- 1R01AG057693-01A1
- Acronym
- INTERCEDE
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2019
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Nayak P, Polonsky T, Tian L, Greenland P, Xu S, Zhang D, Zhao L, Criqui MH, Kibbe MR, Gladders B, Goodney P, Ho K, Guralnik JM, McDermott MM. Medical therapies, comorbid conditions, and functional performance in people with peripheral artery disease enrolled in clinical trials between 2004 and 2021. Vasc Med. 2023 Apr;28(2):144-146. doi: 10.1177/1358863X221145533. Epub 2023 Jan 1.
PubMed 36588397
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease: The INTERCEDE TRIAL
- ClinicalTrials.gov ID
- NCT03871075
- Acronym / sponsor ID
- INTERCEDE / STU00208245
- Conditions
- Peripheral Artery Disease
- Keywords
- peripheral arterial disease, Peripheral Artery Disease, PAD, exercise, Intermittent claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 12 Mar 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 INTERCEDE randomized trial will establish whether six-months of intermittent pneumatic compression combined with walking exercise improves walking endurance at six-month follow-up, compared to walking exercise + sham compression therapy, in people with lower extremity peripheral artery disease (PAD). The INTERCEDE trial will also determine whether intermittent pneumatic compression therapy improves walking endurance at 6-month follow-up, compared to a sham compression therapy. The trial will also determine whether benefits of intermittent pneumatic compression persist after intermittent pneumatic compression treatment is completed.
Detailed description
Walking exercise is first-line therapy for PAD. However, many PAD patients are unable or unwilling to exercise. Therefore, in people with PAD, the investigators will determine whether intermittent pneumatic compression augments the benefits of exercise and whether intermittent pneumatic compression alone improves walking performance compared to sham control. The investigators will conduct a randomized trial (2 x 2 factorial design) of 230 PAD participants randomized to one of four groups: Group A: intermittent pneumatic compression + exercise; Group B: intermittent pneumatic compression+ "no exercise" control; Group C: sham control + exercise; and Group D: sham control + "no exercise" control. The intermittent pneumatic compression and sham interventions will be delivered for six months. The primary outcome is change in six-minute walk distance at 6-month follow-up. In secondary aims, the investigators will determine whether the benefits of intermittent pneumatic compression persist even after intermittent pneumatic compression is discontinued and delineate mechanisms by which intermittent pneumatic compression affects walking performance, by measuring changes in MRI-measured calf muscle perfusion and physical activity. The investigators will determine whether intermittent pneumatic compression improves systemic endothelial function, by measuring changes in brachial artery flow-mediated dilation (FMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IPC + exercise | Experimental | Device: intermittent pneumatic compression, Behavioral: exerciseParticipants will be asked to wear the intermittent pneumatic compression device for up to three hours daily. They will be helped to engage in home-based walking exercise therapy. |
| IPC + "no exercise" control | Experimental | Device: intermittent pneumatic compression, Behavioral: Health EducationParticipants will be asked to wear the intermittent pneumatic compression device for up to three hours daily. They will be asked to participate in an educational/informational intervention consisting of an attention control intervention |
| sham control + exercise | Active comparator | Behavioral: exercise, Device: Sham deviceParticipants will be asked to wear a sham intermittent pneumatic compression device for up to three hours daily. The sham device inflates at the same frequency, but to a much lower systolic pressure, compared to the therapeutic pneumatic compression device. Participants in this group will be helped to engage in home-based walking exercise therapy. |
| sham control + "no exercise" control | Active comparator | Device: Sham device, Behavioral: Health EducationParticipants will be asked to wear a sham intermittent pneumatic compression device for up to three hours daily. The sham device inflates at the same frequency, but to a much lower systolic pressure, compared to the therapeutic pneumatic compression device. Participants will be asked to participate in an educational/informational intervention, designed as an attention control group. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants will have PAD. PAD will be defined as follows: first, an ankle-brachial index (ABI) < or = 0.90 at the baseline study visit is an inclusion criterion for PAD. Second, potential participants with an ABI >0.90 who have vascular laboratory evidence of PAD. Vascular laboratory evidence consists of objective evidence of PAD, including toe brachial index (TBI) < or = 0.70, Duplex measure showing 70% stenosis or greater, or ABI values < 0.90. Abnormal waveforms or pulse volume recordings alone from a non-invasive vascular laboratory test will not be sufficient for enrollment. Third, potential participants with an ABI >0.90 who have angiographic evidence of PAD consisting of a stenosis of 70% or greater in a lower extremity artery.
Key exclusion criteria (20 listed)
- Above- or below-knee amputation.
- Critical limb ischemia or ABI < 0.30 in the setting of ischemic symptoms at rest or physical examination findings consistent with critical limb ischemia. Some potential participants with symptoms or signs of critical limb ischemia may be excluded at the principal investigator's discretion if the ABI is 0.30 or higher.
- Wheelchair-bound.
- Current foot ulcer on bottom of foot.
- Walking is primarily limited by a symptom other than PAD.
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 |
|---|---|---|
| intermittent pneumatic compressionAlso: IPCIntermittent pneumatic compression is a non-invasive intervention, consisting of an air pump inside inflatable cuffs that are wrapped around the feet, ankles, and calves. The cuffs rapidly inflate to a pressure of 120 mm Hg, which is sustained for three seconds, followed by rapid deflation. Participants will be asked to wear the device for two hours daily. The device will inflate 180 times/hour. | Device | IPC + "no exercise" control, IPC + exercise |
| exerciseParticipants will be asked to walk for exercise five days/week, working up to 50 minutes of exercise per day. The intervention includes a) group meetings at the medical center with the coach and other PAD participants; b) regularly scheduled individual telephone check-in by the coach c) weekly remote monitoring by the coach; d) use of the activity monitor to monitor exercise intensity and duration. | Behavioural | IPC + exercise, sham control + exercise |
| Sham deviceThe sham control device is a non-invasive intervention, consisting of an air pump inside inflatable cuffs that are wrapped around the feet, ankles, and calves. The cuffs rapidly inflate to a pressure of 25 mm Hg, which is sustained for three seconds, followed by rapid deflation. Participants will be asked to wear the device for two hours daily. The device will inflate 180 times/hour. | Device | sham control + "no exercise" control, sham control + exercise |
| Health EducationParticipants attend health-education lectures and receive telephone calls at the same frequency as the exercise group. On-site lectures are delivered by faculty and staff at the medical center. Telephone calls review health-related handouts from the NIA website that are mailed in advance of the telephone call. Content does not include exercise information. | Behavioural | IPC + "no exercise" control, sham control + "no exercise" control |
Primary outcome
Six-minute walk distance (intermittent pneumatic compression therapy + exercise v. exercise only)
Time frame: Baseline to 6-month follow-up
Among PAD participants, the investigators will determine whether intermittent pneumatic compression combined with exercise improves the 6-minute walk at 6-month follow-up compared to exercise alone.
Six-minute walk distance (intermittent pneumatic compression therapy alone (without exercise) vs. sham alone (without exercise)
Time frame: Baseline to 6-month follow-up
Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone (without exercise) improves the 6-minute walk at 6-month follow-up, compared to the sham control alone (without exercise).
14 secondary outcomes
Six-minute walk distance (intermittent pneumatic compression therapy + exercise v. exercise only)
Time frame: Baseline to 12-month follow-up
Six-minute walk distance (IPC only v. sham only)
Time frame: Baseline to 12-month follow-up
Calf muscle perfusion (intermittent pneumatic compression therapy + exercise v. exercise only)
Time frame: Baseline to 6-month follow-up
Brachial artery FMD (intermittent pneumatic compression therapy + exercise v. exercise only)
Time frame: Baseline to 6-month follow-up
Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy + exercise v. exercise only)
Time frame: Baseline to 6-month follow-up
Calf muscle perfusion (intermittent pneumatic compression therapy + exercise v. exercise only)
Time frame: Baseline to 12-month follow-up
Brachial artery FMD (intermittent pneumatic compression therapy + exercise v. exercise only)
Time frame: Baseline to 12-month follow-up
Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy + exercise v. exercise only)
Time frame: Baseline to 12-month follow-up
Calf muscle perfusion (intermittent pneumatic compression therapy only v. sham only)
Time frame: Baseline to 6-month follow-up
Brachial artery FMD (intermittent pneumatic compression therapy only v. sham only)
Time frame: Baseline to 6-month follow-up
Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy only v. sham only)
Time frame: Baseline to 6-month follow-up
Calf muscle perfusion (intermittent pneumatic compression therapy only v. sham only)
Time frame: Baseline to 12-month follow-up
Brachial artery FMD (intermittent pneumatic compression therapy only v. sham only)
Time frame: Baseline to 12-month follow-up
Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy only v. sham only)
Time frame: Baseline to 12-month follow-up
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 29 Sep 2026.
- Derived from this study: PubMed 36588397Nayak P, Polonsky T, Tian L, Greenland P, Xu S, Zhang D, Zhao L, Criqui MH, Kibbe MR, Gladders B, Goodney P, Ho K, Guralnik JM, McDermott MM. Medical therapies, comorbid conditions, and functional performance in people with peripheral artery disease enrolled in clinical trials between 2004 and 2021. Vasc Med. 2023 Apr;28(2):144-146. doi: 10.1177/1358863X221145533. Epub 2023 Jan 1.
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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.
Mary McDermott, MD principal investigator
Northwestern Universtiy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent pneumatic compression, exercise and Health Education in people with Peripheral Artery Disease, run by Northwestern University at 4 sites 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 1 inclusion and 20 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 29 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 4 sites 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?
Six-minute walk distance (intermittent pneumatic compression therapy + exercise v. exercise only) (time frame: Baseline to 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03871075, which also lists 1 linked publication.
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 29 Sep 2026.