The impact of Diabetic Neuropathy on physical performance in elderly endividuals with Type 2 Diabetes: a double-blind clinical trial on Combined Training Program
Not Applicable
Recruiting
- Conditions
- Diabetic FootC18.452.394.750.149
- Registration Number
- RBR-6d43xbb
- Lead Sponsor
- niversidade São Judas Tadeu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
Inability to undergo assessments and reassessments; having more than three absences during the training period
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Results of the glycemic profile include glycated hemoglobin, fructosamine, glucose, insulin, and advanced glycation end products (AGEs).