Feet First: Promoting Physical Activity Among People With Diabetes Mellitus and Insensate Feet

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Peripheral Neuropathies

In brief

The role of weight-bearing physical activity in the development of diabetic foot ulcers remains poorly understood. Regular participation in moderately intense physical activity (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus by over 30%. The American Diabetes Association (ADA) recommends at least 30 minutes of daily moderate intensity activity for people with diabetes. However, the ADA recommends that people with diabetes and insensate feet, which affects up to 40% of those with diabetes, should limit their walking because of concerns that walking could increase the risk of foot ulcers and amputation. Firm evidence is lacking to support these concerns; in fact, while a research fellow I conducted an observational study that showed daily weight-bearing activity may reduce the risk of foot ulceration among people with diabetic foot problems. A controlled clinical trial is needed to study these issues further. The present study is a randomized controlled trial in 100 older adults with diabetes and insensate feet, 50 of whom will participate in an individually-tailored behavior-change intervention called "Feet First", and 50 of whom will be controls. The intervention is based on the extensively-tested CHAMPS model used by the Robert Wood Johnson Foundation's Active for Life Program. Feet First extends the target population beyond older adults generally to people with insensate feet due to diabetic peripheral neuropathy. The specific aims of the study are: * To determine whether Feet First intervention subjects achieve a greater increase in weight-bearing activity than control subjects, and * To obtain preliminary evidence on intervention subjects' foot outcomes (foot function, foot-related self-care, and risk of foot ulcers), compared to control subjects.

Key facts

Study ID

NCT00286598

Run by

University of Missouri-Columbia

People needed

79

Starts

2005-01-01

Expected to finish

2008-06-01

Last updated by the study team

2016-10-05

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed type 1 or 2 diabetes mellitus
• Age 50 years or older
• Absent 5.07 Semmes Weinstein monofilament sensation to > 1 point on both feet
• Residence within 50 miles of Columbia, MO
• Functioning telephone service
• Not currently participating in 20 or more minutes of moderately intense activity more than twice a week

You may not qualify if…

• Hospitalization in the last year for any of the following reasons:
• Proliferative diabetic retinopathy
• Accelerated hypertension (systolic BP >200 or diastolic BP > 120)
• Myocardial infarction or unstable angina
• New hemodynamically significant arrhythmia
• Acute congestive heart failure
• Failure to attend 3 of the last 5 scheduled clinic visits
• Foot deformities requiring a custom shoe
• "Timed Up and Go" test 3 > 15 seconds Subjects unable to ambulate without assistance
• Severe cardiac autonomic neuropathy
• Lower extremity amputation > one digit
• Heart, kidney or other transplant
• Currently unhealed foot ulcer (or healed for less than 1 month

Where it is running

• University of Missouri — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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