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CompletedNCT03871075INTERCEDEUpdated Sep 29, 2026

Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease

An interventional study of intermittent pneumatic compression and exercise in Peripheral Artery Disease, sponsored by Northwestern University. Completed at 4 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

Updated Sep 29, 2026Now CompletedPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
211
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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). 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).

02

Conditions studied

  • Peripheral Artery Disease

Keywords

  • peripheral arterial disease
  • Peripheral Artery Disease
  • PAD
  • exercise
  • Intermittent claudication
03

In context

Peripheral Arterial Disease

1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.

This study's enrollment of 211 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.

Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.

Browse Northwestern University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  1. Above- or below-knee amputation.
  2. 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.
  3. Wheelchair-bound.
  4. Current foot ulcer on bottom of foot.
  5. Walking is primarily limited by a symptom other than PAD.
  6. Failure to successfully complete the study run-in.
  7. Major surgery, revascularization, or orthopedic surgery in the past 3 months or planned in the next 12 months.
  8. 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 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.]
  9. Already exercising at a level consistent with exercise intervention. Current or recent participation in exercise rehabilitation (within the past three months).
  10. Recently diagnosed (within the past three months) with acute lower extremity deep venous thrombosis, pulmonary embolism, or severe heart failure (i.e. (NYHA) Class III or IV).
  11. Mini-Mental Status Examination () score \<23 or dementia.
  12. Participation in or completion of a clinical trial in the previous three months.
  13. Non-English speaking.
  14. 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.
  15. Ongoing infection of the toes, foot, or lower extremity.
  16. 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.
  17. Significant peripheral edema, defined as 3+ or greater edema severity, as determined by the principal investigator.
  18. >45 kg/M2
  19. Significant visual impairment that interferes with walking.
  20. 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
211 participants (actual)

Study arms

  • Experimental
    IPC + exercise

    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.

    Device: intermittent pneumatic compression · Behavioral: exercise

  • Experimental
    IPC + "no exercise" control

    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

    Device: intermittent pneumatic compression · Behavioral: Health Education

  • Active comparator
    sham control + exercise

    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.

    Behavioral: exercise · Device: Sham device

  • Active comparator
    sham control + "no exercise" control

    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.

    Device: Sham device · Behavioral: Health Education

Interventions

  • Deviceintermittent pneumatic compression

    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.

    Also known as: IPC

  • Behavioralexercise

    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.

  • DeviceSham device

    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.

  • BehavioralHealth Education

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 6-month follow-up

  2. 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).

    Time frame: Baseline to 6-month follow-up

Secondary outcomes

  1. 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.

    Time frame: Baseline to 12-month follow-up

  2. 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.

    Time frame: Baseline to 12-month follow-up

  3. 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.

    Time frame: Baseline to 6-month follow-up

  4. 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.

    Time frame: Baseline to 6-month follow-up

  5. 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.

    Time frame: Baseline to 6-month follow-up

  6. 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.

    Time frame: Baseline to 12-month follow-up

  7. 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.

    Time frame: Baseline to 12-month follow-up

  8. 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.

    Time frame: Baseline to 12-month follow-up

  9. 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.

    Time frame: Baseline to 6-month follow-up

  10. 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.

    Time frame: Baseline to 6-month follow-up

  11. 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.

    Time frame: Baseline to 6-month follow-up

  12. 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.

    Time frame: Baseline to 12-month follow-up

  13. 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.

    Time frame: Baseline to 12-month follow-up

  14. 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.

    Time frame: Baseline to 12-month follow-up

Other outcomes

  1. Mitochondrial biogenesis (intermittent pneumatic compression therapy + exercise v. exercise only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves mitochondrial biogenesis (PGC-1α) at 6-month follow- up, compared to exercise alone.

    Time frame: Baseline to 6-month follow-up

  2. Mitochondrial activity (intermittent pneumatic compression therapy + exercise v. exercise only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves mitochondrial activity (Cytochrome C oxidase) at 6-month follow- up, compared to exercise alone.

    Time frame: Baseline to 6-month follow-up

  3. Vascular endothelial growth factor abundance (intermittent pneumatic compression therapy + exercise v. exercise only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves vascular endothelial growth factor abundance at 6-month follow- up, compared to exercise alone.

    Time frame: Baseline to 6-month follow-up

  4. Anti-oxidant enzyme activity (intermittent pneumatic compression therapy + exercise v. exercise only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves anti-oxidant enzyme activity (MnSOD) at 6-month follow- up, compared to exercise alone.

    Time frame: Baseline to 6-month follow-up

  5. Immunohistochemistry-measured mitochondrial activity (intermittent pneumatic compression therapy + exercise v. exercise only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves immunohistochemistry-measured mitochondrial activity (COX and SDH) at 6-month follow- up, compared to exercise alone.

    Time frame: Baseline to 6-month follow-up

  6. Autophagy (intermittent pneumatic compression therapy + exercise v. exercise only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves autophagy (LC3, LAMP2, PARKIN) at 6-month follow- up, compared to exercise alone.

    Time frame: Baseline to 6-month follow-up

  7. Capillary density (intermittent pneumatic compression therapy + exercise v. exercise only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves capillary density (CD31) at 6-month follow- up, compared to exercise alone.

    Time frame: Baseline to 6-month follow-up

  8. Satellite cell content (intermittent pneumatic compression therapy + exercise v. exercise only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves satellite cell content (Pax7) at 6-month follow- up, compared to exercise alone.

    Time frame: Baseline to 6-month follow-up

  9. Mitochondrial biogenesis (intermittent pneumatic compression therapy only v. sham only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves mitochondrial biogenesis (PGC-1α) at 6-month follow- up, compared to the sham control.

    Time frame: Baseline to 6-month follow-up

  10. Mitochondrial activity (intermittent pneumatic compression therapy only v. sham only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves mitochondrial activity (Cytochrome C oxidase) at 6-month follow- up, compared to the sham control.

    Time frame: Baseline to 6-month follow-up

  11. Vascular endothelial growth factor abundance (intermittent pneumatic compression therapy only v. sham only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves vascular endothelial growth factor abundance at 6-month follow- up, compared to the sham control.

    Time frame: Baseline to 6-month follow-up

  12. Anti-oxidant enzyme activity (intermittent pneumatic compression therapy only v. sham only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves anti-oxidant enzyme activity (MnSOD) at 6-month follow- up, compared to the sham control.

    Time frame: Baseline to 6-month follow-up

  13. Immunohistochemistry-measured mitochondrial activity (intermittent pneumatic compression therapy only v. sham only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves immunohistochemistry-measured mitochondrial activity (COX and SDH) at 6-month follow- up, compared to the sham control.

    Time frame: Baseline to 6-month follow-up

  14. Autophagy (intermittent pneumatic compression therapy only v. sham only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves autophagy (LC3, LAMP2, PARKIN) at 6-month follow- up, compared to the sham control.

    Time frame: Baseline to 6-month follow-up

  15. Capillary density (intermittent pneumatic compression therapy only v. sham only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves capillary density (CD31) at 6-month follow- up, compared to the sham control.

    Time frame: Baseline to 6-month follow-up

  16. Satellite cell content (intermittent pneumatic compression therapy only v. sham only)

    Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves satellite cell content (Pax7) at 6-month follow- up, compared to the sham control

    Time frame: Baseline to 6-month follow-up

07

Study locations

4 sites
  • Northwestern University
    Chicago, Illinois 60611, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Henry Ford Health
    Detroit, Michigan 48202, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

References and documents

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 ↗
09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Sep 29, 2026
Primary completion
Sep 2026→Aug 28, 2026 (actual)
Sep 29, 2026
Study completion
Apr 2027→Sep 17, 2026 (actual)
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Active, not recruiting→Completed
    Primary completion Sep 2026→Aug 28, 2026 (now actual)
    Study completion Apr 2027→Sep 17, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03871075
Lead sponsor
Northwestern University
Collaborators
National Institute on Aging (NIA)
Responsible party
Mary McDermott (Professor of Medicine, Northwestern University) — Principal investigator
First posted
Mar 12, 2019
Start date
Jan 2, 2019
Primary completion
Aug 28, 2026
Completion
Sep 17, 2026
Last update
Sep 29, 2026

Study contacts

Mary McDermott, MD
principal investigator · Northwestern Universtiy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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