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

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.

Conditions

• Peripheral Artery Disease

Interventions

DEVICE

intermittent 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.

BEHAVIORAL

exercise

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.

DEVICE

Sham 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.

BEHAVIORAL

Health 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.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Northwestern University

  lead OTHER

Principal Investigators

• Mary McDermott, MD · Northwestern Universtiy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-02

Primary Completion

2026-07-31

Completion

2026-11-30

FDA Device

Yes

Countries

• United States

Study Locations