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

NCT00286598 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2016-10-05

No results posted yet for this study

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 ) 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.

Conditions

Interventions

BEHAVIORAL

Feet First

Phase 1: (enrollment to 3 months) 8 sessions with a physical therapist learning leg strengthening and balance exercises, and initiating a walking program Phase 2: Motivational enhancement calls from a nurse every 2 weeks.

Sponsors & Collaborators

  • Robert Wood Johnson Foundation

    collaborator OTHER

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Joseph W LeMaster, MD, MPH · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00286598 on ClinicalTrials.gov