Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease: The INTERCEDE TRIAL
Northwestern University
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.
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 e…
Eligibility
- Age range
- 55+ years
- Sex
- All
- Healthy volunteers
- No
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 sufficien…
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.
- 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.
Locations (4)
- Northwestern UniversityChicago, Illinois
- University of ChicagoChicago, Illinois
- Henry Ford HealthDetroit, Michigan
- University of MinnesotaMinneapolis, Minnesota