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

NARecruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

January 2, 2019

Primary Completion Date

July 31, 2026

Study Completion Date

November 30, 2026

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.

Trial Locations (4)

48202

RECRUITING

Henry Ford Health, Detroit

55455

RECRUITING

University of Minnesota, Minneapolis

60611

RECRUITING

Northwestern University, Chicago

60637

RECRUITING

University of Chicago, Chicago

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

Northwestern University

OTHER