Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial.

Renan L Monteiro,Érica Q Silva,Asha Donini,Isabel C.N Sacco,Sicco A Bus,Jady L Verissímo,Ronaldo H Cruvinel-Júnior,Jane S.S.P Ferreira

doi:10.3390/s20185129

Abstract

Foot-ankle strengthening and mobility exercises are part of international guideline recommendations for people at risk of diabetic foot disease. We examined the feasibility and preliminary efficacy of a 12-week foot-ankle exercise program on clinical, functional and biomechanical outcomes in people with diabetic neuropathy (DPN). We randomly allocated 30 people with DPN to usual care (control) or usual care plus a supervised exercise program (intervention). For feasibility, we assessed recruitment rate and participant adherence and satisfaction. For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests (p < 0.05). In 52 weeks, we recruited 45 eligible participants (0.90/week). Program adherence was 80% and participants’ satisfaction had a mean (SD) of 4.57 (0.70) out of 5. The intervention group significantly improved on toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures increased over time; controls showed significantly increased heel peak pressures and force. The exercise program was feasible, based on a moderate recruitment rate and an adherent and satisfied population, and the intervention showed several positive preliminary effects over time compared to usual care.

Highlights

Diabetic neuropathy (DPN) is a symmetrical disorder, either clinically evident or subclinical, that occurs in people with diabetes; DPN is attributable to metabolic and microvascular alterations resulting from chronic hyperglycemia exposure as well as to cardiovascular risk covariates [1]
Researchers have recognized that research on the efficacy of interventions can be accelerated if careful feasibility and pilot studies assessing the preliminary efficacy of certain interventions are conducted prior to conducting large randomized controlled trials (RCTs) [50]
The increased forefoot pressures may have been due to the changing role of the forefoot in gait propulsion given that the intervention focused on improving the intrinsic foot muscle strength and function. These findings suggest that while attention must be devoted in keeping plantar pressures below the risk threshold for ulceration in people with DPN [60], this should not be the sole aim of physiotherapeutic interventions, as the results showed that the foot-ankle exercise programs demonstrated several beneficial effects in the investigated population

Summary

Introduction

Diabetic neuropathy (DPN) is a symmetrical disorder, either clinically evident or subclinical, that occurs in people with diabetes; DPN is attributable to metabolic and microvascular alterations resulting from chronic hyperglycemia exposure as well as to cardiovascular risk covariates [1]. Supervised foot-related exercises combined with a health-promoting program were shown to effectively reduce DPN symptoms [10,11], improve vibration perception [12], recover foot and ankle joint mobility [12,13,14,15,16], redistribute pressure during walking [12,13,15,17,18,19,20] and increase foot strength and function [10,21,22] All of these benefits mitigate the risk factors for foot ulceration in diabetes. It is still unclear how the compliance with this type of preventive programs would be in this population and whether the recruitment for a trial that tests the efficacy of these physiotherapy programs would be feasible

Objectives

Discussion

Conclusion