RecruitingNot ApplicableNCT05639478

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


Sponsor

University of Sao Paulo General Hospital

Enrollment

356 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Adults of both sexes;
  • Diabetes mellitus type 1 or 2;
  • Residence within the catchment area of the Family Health Units.
  • Availability to participate in the intervention at the established group time.
  • Clinical diagnosis of dementia;
  • Inability to provide reliable and consistent information;
  • Perform physiotherapy intervention throughout the intervention period;
  • Active foot ulcer or major vascular complications.

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Interventions

OTHERFoot-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.


Locations(1)

Equipe Multidisciplinar E-Multi

Limeira, São Paulo, Brazil

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NCT05639478