Fall and balance outcomes after an intervention to promote leg strength, balance, and walking in people with diabetic peripheral neuropathy: "feet first" randomized controlled trial

Abstract

Background: Weight-bearing exercise has been discouraged for people with diabetes mellitus and peripheral neuropathy (DM+PN). However, people with diabetes mellitus and insensate feet have an increased risk of falling. Lower-extremity exercise and balance training reduce fall risk in some older adults. It is unknown whether those with neuropathy experience similar benefits.

Objective: As part of a study of the effects of weight-bearing exercise on foot ulceration in people with DM+PN, the effects of a lower-extremity exercise and walking intervention on balance, lower-extremity strength (force-generating capacity), and fall incidence were determined. Design The study was an observer-masked, 12-month randomized controlled trial.

Setting: Part 1 of the intervention took place in physical therapy offices, and part 2 took place in the community.

Patients: The participants were 79 people who were mostly sedentary, who had DM+PN, and who were randomly assigned to either a control group (n=38) or an intervention group (n=41). Intervention Part 1 included leg strengthening and balance exercises and a graduated, self-monitored walking program; part 2 included motivational telephone calls. Both groups received regular foot care, foot care education, and 8 sessions with a physical therapist.

Measurements: The measurements collected were strength, balance, and participant-reported falls for the year after enrollment.

Results: There were no statistically significant differences between the groups for falls during follow-up. At 12 months, there was a small increase in the amount of time that participants in the intervention group could stand on 1 leg with their eyes closed. No other strength or balance measurements differed between the groups.

Limitations: The study was designed to detect differences in physical activity, not falls. The intensity of the intervention was insufficient to improve strength and balance in this population.

Conclusions: The training program had a minimal effect on participants' balance and lower-extremity strength. Increasing weight-bearing activity did not alter the rate of falling for participants in the intervention group relative to that for participants in the control group. People who are sedentary and who have DM+PN appear to be able to increase activity without increasing their rate of falling.

Trial registration: ClinicalTrials.gov NCT00286598.