RESUMO
Background: People with diabetes and diabetic peripheral neuropathy (DPN) often develop calluses due to toe misalignment and increased plantar pressure. Untreated, these issues can progress into ulcers, making early intervention crucial. This trial protocol aims to evaluate the efficacy and safety of customized silicone digital orthoses in preventing ulcers, pre-ulcerative lesions, and peak pressure during gait in people with DPN. Methods: In this superiority randomized controlled parallel trial with single-blind assessment, 60 participants will be allocated to the control group (CG) or the intervention group (IG). The CG will receive specialized nurse-administered foot care, including callus removal, nail care guidance, and self-care education. The IG will receive the same care plus a customized silicone orthosis for toe realignment for 6 months. Assessments will occur at baseline and 3 and 6 months for the primary outcomes (pre-ulcerative lesions and ulcer incidence) and secondary outcomes (pressure distribution, foot function and health, quality of life, safety, and comfort). Two-way ANOVAs (p < .05) will assess group, time, and group by time effects following an intention-to-treat approach. Conclusion: Although recommended for foot ulcer prevention, custom silicone orthosis adoption remains limited due to the low certainty of evidence. This trial seeks to provide more consistent evidence for the use of toe orthoses in preventing callus and ulcer formation for individuals with DPN. Trial registry: ClinicalTrials.gov (NCT05683106) "Effects of Customized Silicone Digital Orthoses in People with Diabetic Neuropathy" (registered on December 20, 2022).
RESUMO
Introdução: O volume em uma sessão de treinamento de força (TF) pode alterar a flexibilidade. Objetivo: Verificar o efeito agudo de uma sessão de TF com diferentes volumes na flexibilidade, imediatamente após o término da sessão e 24 e 48 horas após. Métodos: Sessenta e um voluntários (24,31±0,81anos) do sexo masculino distribuídos aleatoriamente em três grupos: grupo controle (GC), duas série (G2S) e três séries (G3S). Todos os grupos foram avaliados pré e pós-treinamento no teste de sentar e alcançar, Goniometria (ombro, cotovelo, quadril, joelho e coluna) e teste de 10 Repetições Máximas (RM). O treinamento foi composto por nove exercícios que envolviam todas as articulações avaliadas e executado 10 repetições. Resultados: Houve aumento dos níveis de flexibilidade para maioria dos movimentos do ombro; quadril (extensão) e tronco (flexão e extensão) quando comparadas as situações pré e pós-treinamento para todos os grupos submetidos ao treinamento (p < 0,05). Conclusão: Uma sessão de ER com diferentes volumes é capaz de modificar a flexibilidade de articulações triaxiais.
Introduction: The volume in a resistance exercise (RE) session can change flexibility. Objective: The aim of the study was to investigate the acute effect of a training session with different volumes flexibility, immediately after the session and 24 and 48 hours after the training session. Methods: Study participants were 61 volunteers (24.31 ± 0,81 year) males randomly assigned to three groups: control group (CG), two series (G2S) and three series (G3S). All groups were assessed before and after training in the sit and reach test, Goniometry (shoulder, elbow, hip, knee and spine) and test 10 Maximum Repetitions (RM). The training was composed of nine exercises that involved all tested joints and was run 10 repetitions of each exercise with moderate intensity. Results: There was an increase of the flexibility levels for most shoulder movements; hip (extension) and trunk (flexion and extension) when comparing before and after training for all undergoing training groups (p <0.05). Conclusion: A RE session with different volumes is able to modify the flexibility of triaxial joints.
