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Intermittent Pneumatic Compression with and without Exercise to Improve Functioning in Peripheral Artery Disease: The INTERCEDE TRIAL
Recruiting
The purpose of this study is to establish whether the device, intermittent pneumatic compression (IPC), both with and without walking exercise, can improve the ability to walk and prevent decline in the ability to walk for people with PAD. Intermittent pneumatic compression consists of blood pressure cuffs that are wrapped around the lower legs (below the knees) that inflate three times per minute. These cuffs may improve blood flow to the lower legs and feet.
Male or Female
18 years and over
Inclusion Criteria:
• diagnosis of Peripheral Artery Disease (PAD) based on specific criteria that study staff will review
Exclusion Criteria:
• above or below-knee amputation
• wheelchair-bound
• currently have a foot ulcer on bottom of foot or ongoing infection of the toes, foot, or lower extremity
• walking is limited by a symptom other than PAD
• major surgery, revascularization, or orthopedic surgery in the past 3 months or planned in the next 12 months
• already exercising at a level consistent with exercise intervention. Current or recent participation in exercise rehabilitation (within the past three months)
• non English speaking
• BMI greater than 45kg/M2
• major medical illness including Parkinson's Disease, lung disease requiring oxygen, cancer requiring treatment in the previous two years, or life-threatening illness (study staff will review)
Behavioral: Health Education, Device: Sham device, Behavioral: exercise, Device: intermittent pneumatic compression
Heart & Vascular
peripheral arterial disease, cocoa, intercede, pad, peripheral artery disease, prove
Mattie Leavens - leave039@umn.edu
Diane Treat-Jacobson
N/A
STUDY00013094
See this study on ClinicalTrials.gov