Effects of foot muscle strengthening on physical activity of daily living and ankle and foot functionality in people with diabetic polyneuropathy: a randomized controlled clinical trial

Author(s)

Renan Lima Monteiro

• Document type: Doctoral Thesis
• Press: São Paulo.
• Institution: Universidade de São Paulo (USP). Faculdade de Medicina (FM/SBD)
• Defense date: 2021-12-08

Examining board members

Isabel de Camargo Neves Sacco; Sharon Nina Admoni; Leonardo Oliveira Pena Costa; Renan Alves Resende

• Advisor: Isabel de Camargo Neves Sacco

Abstract

The increase in the number of cases of people with diabetes is contributing to a rapid increase in the number of cases of associated complications, such as diabetic peripheral neuropathy (DPN), which leads these people to live with disabilities and reduced functionality for a long period of their lives due to sensory and musculoskeletal impairment. According to the Global Burden of Diseases, Injuries, and Risk Factors Study (2019), the need for rehabilitation may be necessary for anyone with health conditions that lead to mobility, sensory or cognitive deficits, with musculoskeletal deficits being the most prevalent. However, currently there is little and weak evidence of therapeutic strategies to mitigate and rehabilitate musculoskeletal deficits arising from DPN, which contributes to the neglect of rehabilitation services in the treatment and prevention of these functional complications. Thus, this thesis sought to propose, test the feasibility and effectiveness through a randomized and controlled clinical trial of a 12-week therapeutic foot exercise program on the levels of physical activity and gait speed of people with DPN, as well as its effects on DPN-related clinical and functional outcomes, such as ankle range of motion, tactile and vibratory sensitivity, DPN symptoms (outcomes that are risk factors for plantar ulcers), quality of life, foot health, muscle strength and incidence of ulcers. In addition to the baseline assessment, reassessments were performed after 6, 12, 24 weeks and 1 year. 78 participants were allocated into groups: intervention group (n=39, 61.6 ± 11.6 years) and control group (n=39, 60.0 ± 9.0 years). The first step in the construction of this thesis was the elaboration of a physical therapy exercise protocol that focused on DPN-related musculoskeletal deficits. Initially, the cascade of complications arising from DPN, as well as the definition of the main outcomes of the study, was discussed with specialists in the field of DPN and physiotherapists specialized in foot rehabilitation. Physical activity levels, measured by the number of steps, and gait speed were defined as the main outcomes as they directly reflect the physical functional capacity of the person with diabetes. Then, rehabilitation strategies were discussed focusing on physical functional deficits, such as loss of intrinsic and extrinsic muscle strength of the feet, joint stiffness and decreased mobility, and from these deficits, the rehabilitation protocol was developed through exercises for strengthening and mobility, as well as functional exercises. Performing the exercises in groups of up to 8 people and progressing the exercises individually were strategies adopted to increase adherence and enhance the effects of the exercises. After the development and publication of the study protocol, the second step of this thesis was to assess the feasibility of the clinical trial and the exercise protocol, as the scarcity of studies in the area and the innovative exercise protocol led us to question its feasibility, as well as the satisfaction and adherence of the participants to the protocol. The exercise program was feasible, based on a moderate recruitment rate and an adherent (80%) and satisfied population (mean satisfaction 4.6 out of 5), and the intervention showed positive preliminary effects over time compared with the group control. The third and final step for the construction of this thesis was the development of the clinical trial itself. The results of this clinical trial showed that xii 12 weeks of foot-specific exercises focusing on the musculoskeletal deficits of people with DPN were able to increase fast gait speed and ankle range of motion, improve vibratory sensitivity and quality of life in comparison with the control group after 12 weeks. After 24 weeks, the proposed intervention resulted in a better quality of life compared to the control group. And after 1 year of follow-up, fast gait speed and vibratory sensitivity improved in the intervention group compared to the control group. Thus, we can conclude that the rehabilitation protocol is viable, resulted in positive outcomes for people with diabetes and DPN, and it is possible to suggest the inclusion of this approach as an alternative treatment and prevention of musculoskeletal complications related to DPN, although there is still no evidence in reducing the incidence of plantar ulcers (AU)

• FAPESP's process: 17/17848-3 - Effects of foot muscle strengthening in daily activity and functionality of foot and ankle in diabetic polyneuropathy patients: a randomized controlled trial
• Grantee: Renan Lima Monteiro
• Support Opportunities: Scholarships in Brazil - Doctorate