Diabetic Foot
Conditions
Interventions
This is a double-blind, non-randomized clinical trial. It will evaluate 46 participants divided into two groups: the group without diabetic neuropathy (n=23) and the group with diabetic neuropathy (n=
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Sponsors
Universidade São Judas Tadeu
Instituto de Ortopedia e Traumatologia do Hospital das Clínica da Faculdade de Medicina da Universidade São Paulo (IOT-HC/FMUSP)
Eligibility
Age
60 Years to 79 Years
Inclusion criteria
Inclusion criteria: Elderly patients aged 60 to 79 years; both genders; diagnosed with type 2 diabetes mellitus for more than two years; on a stable dose of medication (oral antidiabetics, insulin, or a combination of both) for over a year; glycated hemoglobin between 6 and 9.0%; Montreal Cognitive Assessment (MoCA) score above 26; without musculoskeletal system impairment; pain; any type of disabling disease or previous surgeries that could hinder physical training; without inadequately treated and decompensated chronic non-communicable disease
Exclusion criteria
Exclusion criteria: Inability to undergo assessments and reassessments; having more than three absences during the training period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is related to physical performance, including measurements of grip strength in kg/f and the Short Physical Performance Battery (SPPB) test, which consists of the sum of scores (1 to 12 points) from balance test, gait speed test (s), and chair stand test, Timed Up and Go (TUG) test with and without a cognitive task (measured in time), and finally the Senior Fitness tests, which include: upper and lower body flexibility measured in centimeters, upper and lower body strength test measured in number of repetitions, mobility test measured in time, seconds (s), and the 6-minute walk test, measured in meters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Results of the glycemic profile include glycated hemoglobin, fructosamine, glucose, insulin, and advanced glycation end products (AGEs). | — |
Countries
Brazil
Contacts
Public ContactMatheus Lino
Universidade São Judas Tadeu
Outcome results
None listed