Status:
COMPLETED
Feet First: Promoting Physical Activity Among People With Diabetes Mellitus and Insensate Feet
Lead Sponsor:
University of Missouri-Columbia
Collaborating Sponsors:
Robert Wood Johnson Foundation
Conditions:
Diabetes Mellitus
Peripheral Neuropathies
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
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 ) r...
Detailed Description
Physical activity is a vital component of self-management for patients with diabetes mellitus, yet there are special problems in patients whose disease is complicated by insensate feet (i.e. loss of p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00286598
Start Date
January 1 2005
End Date
June 1 2008
Last Update
October 5 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Missouri
Columbia, Missouri, United States, 65212