Avaliação dos desfechos funcionais pelo uso do programa de exercícios personalizados do software SOPeD por pessoas com doença do pé diabético e alto risco de ulcerações: um estudo de viabilidade para um ensaio clínico

Abstract

Introduction: Diabetic foot, a complication of diabetes mellitus, is one of the main causes of morbidity and mortality in people with diabetes, characterized by infection, ulceration or destruction of foot tissues. Diabetic peripheral neuropathy (DPN), commonly associated with diabetes, results in loss of sensation and biomechanical changes that increase the risk of foot ulcers, a significant complication associated with high morbidity, mortality and economic costs. Prevention strategies, such as therapeutic exercises, are essential to reduce costs and morbidity and mortality in this population. eHealth, including the "Diabetic Foot Guidance System" (SOPeD), presents itself as a promising tool for offering broad and accessible interventions. This study evaluated the feasibility and preliminary effects of 10 weeks of a specific exercise program for feet and ankles based on SOPeD, in people with moderate to severe DPN, at high risk of ulcers, compared to usual care recommended by multidisciplinary healthcare teams. Method: Prospective study, with blinded evaluators, involving 13 participants recruited pre-discharge at a Teaching Hospital in the city of Belo Horizonte. The sample was randomized into a Control Group (CG), which received usual care, and an Intervention Group (IG), which received usual care plus an exercise program based on SOPeD. The intervention took place three times a week over 10 weeks. To assess feasibility, recruitment and adherence rates were measured, and to assess preliminary clinical and functional effects, muscle strength, active range of motion, DPN symptoms, quality of life, health and functionality of the feet and ankles. Analysis of outcome variables between groups and between assessments was conducted using 2-way ANOVAs for repeated measures, followed by Newman-Keuls post hoc tests (p<0.05). Results: During a period of 16 weeks, among the 340 patients treated at the Vascular Surgery Service of Hospital Risoleta Tolentino Neves (HRTN), 165 were screened, 76 pre-eligible and 20 classified as eligible. The recruitment rate achieved was 1.25 participants per week, with a recruitment success rate of 65%. Adherence to the intervention program reached 54.3%. When we examined the clinical outcomes, the IG achieved an improvement in isometric muscle strength in plantar flexion after 10 weeks (p=0.017) and a reduction in the severity of DPN compared to the CG (p=0.021). Conclusion: The SOPeD-based program did not prove to be viable for the population with moderate to severe DPN in the HRTN, as there was a low recruitment rate, high dropout rate, due to deaths and readmissions; and moderate adherence to treatment. Despite its relative impracticality, the exercise program was effective in reducing the severity of DPN and improving the strength of the ankle muscles that perform plantar flexion in people with moderate to severe DPN. The occurrence of participant losses over the 10 weeks, the complexity of these participants' health and the restricted sample size made it difficult to find conclusive results.