NCT05639478

FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care

Implementing a Contextually Appropriate Intervention Strategy in Primary Care for the Foot-ankle of People With Diabetes to Improve Clinical and Functional Status and Quality of Life

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 356 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira/SP, through the training of Primary Care workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.

Detailed description

The study is a type 2 hybrid implementation effectiveness trial, whose objective is to simultaneously test the clinical intervention and the implementation strategy. The study will take place in 4 phases, the first being pre-implementation, whose objective is to gather information about local characteristics, barriers and facilitators, and constitute the implementation team. During the second phase, the implementation team will be responsible for structuring the actions for the implementation of the intervention, adapting it to the context defined in phase 1, developing strategies for the training of primary care workers. In phase 3, we will implement the intervention either using a software or a booklet for people with diabetes and we will monitor the participants' diabetes-related, functional and quality of life outcomes after the 12 weeks of intervention. Reach, adoption and implementation will be evaluated using the RE-AIM tool. In phase 4 - \_maintenance - \_the municipality will be responsible for maintaining, expanding and improving the changes achieved, promoting the sharing of experience with other public and private institutions, facilitating the diffusion of similar programs. Specifically in the phase 3, a randomized controlled trial will be performed with 356 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform face to face exercises, supervised by physiotherapists for 12-weeks. The subjects will be evaluated in 2 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) range of motion of the ankle and first metatarsophalangeal joint, (3) fuzzy score of the neuropathy severity, (4) Time up and go, (5) hallux and toes strength (by a pressure plate measurement , (6) hallux strength (by the enhanced paper grip test),(7) ulcers and pre-ulcerative lesions and (8) quality of life (EQ-5D). The hypothesis of this study is that the intervention will reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, as well increase range of motion, functionality and quality of life.

Conditions

• Diabetes; Neuropathy, Polyneuropathy (Manifestation)

Interventions

Type	Name	Description
OTHER	Foot-related exercises	Face to face foot-related exercises, supervised by physiotherapist and based in the specific software (Sistema de Orientação do Pé diabético, SOPED) and or booklet, in addition to self-care recommendations and foot care by international consensus. The maximum duration of a session is 40 min and should be be performed 1-2 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the physiotherapist. The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression.

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-06-30
• Completion: 2026-08-31
• First posted: 2022-12-06
• Last updated: 2026-02-24

Locations

1 site across 1 country: Brazil