Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease
INTERCEDE
2 other identifiers
interventional
230
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2019
CompletedFirst Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
August 29, 2025
August 1, 2025
7.5 years
February 19, 2019
August 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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).
Baseline to 6-month follow-up
Secondary Outcomes (14)
Six-minute walk distance (intermittent pneumatic compression therapy + exercise v. exercise only)
Baseline to 12-month follow-up
Six-minute walk distance (IPC only v. sham only)
Baseline to 12-month follow-up
Calf muscle perfusion (intermittent pneumatic compression therapy + exercise v. exercise only)
Baseline to 6-month follow-up
Brachial artery FMD (intermittent pneumatic compression therapy + exercise v. exercise only)
Baseline to 6-month follow-up
Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy + exercise v. exercise only)
Baseline to 6-month follow-up
- +9 more secondary outcomes
Other Outcomes (16)
Mitochondrial biogenesis (intermittent pneumatic compression therapy + exercise v. exercise only)
Baseline to 6-month follow-up
Mitochondrial activity (intermittent pneumatic compression therapy + exercise v. exercise only)
Baseline to 6-month follow-up
Vascular endothelial growth factor abundance (intermittent pneumatic compression therapy + exercise v. exercise only)
Baseline to 6-month follow-up
- +13 more other outcomes
Study Arms (4)
IPC + exercise
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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 COMPARATORParticipants 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 COMPARATORParticipants 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may not qualify if:
- 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.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (4)
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
Related Publications (1)
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.
PMID: 36588397DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary McDermott, MD
Northwestern Universtiy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Group assignment regarding the intermittent pneumatic compression device is double-blinded and neither investigators nor participants in the study will know which intermittent pneumatic compression device each participant has (therapeutic intervention vs. sham). Participants will be aware of their exercise group assignment after randomization, but the study coordinators collecting follow-up data will be unaware of each participant's group assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
February 19, 2019
First Posted
March 12, 2019
Study Start
January 2, 2019
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
August 29, 2025
Record last verified: 2025-08