Diabetes Mellitus, Type 2
Conditions
Interventions
This is a comparative randomized clinical trial with two parallel, single-blinded arms in which the outcome assessors will be blinded. It will not be possible to blind the participants in the interven
G11.427.410.698.277
Sponsors
Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
Eligibility
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: The sample will consist of adults and elderly people with type 2 diabetes (T2D), of both sexes, aged between 45 and 80 years. Individuals diagnosed with T2D, through laboratory tests and/or use of hypoglycemic medications, will participate in the sample, following the eligibility criteria: HbA1c levels between 6,5 - 10%, not using exogenous insulin, exempt from regular physical exercise (regular practice of exercise will be defined as performing any type of physical training for at least 20 minutes on two or more days of the week) for at least three months, absence of uncontrolled hypertension, absence of autonomic neuropathy, absence of severe peripheral neuropathy, absence of retinopathy proliferative and severe non-proliferative, absence of uncompensated heart failure, absence of peripheral amputation, absence of chronic renal failure and absence of joint or muscular impairments that prevent physical exercise and body mass index (BMI) = 40 kg/m².
Exclusion criteria
Exclusion criteria: Individuals without confirmed type 2 diabetes, under 45 years of age or over 80 years of age, using exogenous insulin, who are regularly practicing physical exercise, with chronic complications that limit the performance of exercises safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in HbA1c levels in the aquatic training group of 0.4% compared to the land training group after 24 weeks, with the outcome being evaluated from a whole blood sample using the Liquid Chromatography methodology. High Performance. | — |
Secondary
| Measure | Time frame |
|---|---|
| We expected to find similar improvements in both combined training groups (aquatic and terrestrial) of at least 1 point in mental health variables verified by the self-administered PHQ-9 questionnaire, in sleep quality verified by the Pittsburgh scale, in cognitive status verified by the MoCA, Digit Span Test and Stroop Color Test instruments, in the perception of the impact of diabetes and treatment verified by the Problems Areas in Diabetes Scale (PAID) questionnaire and in quality of life verified by the WHOQOL-8 questionnaire after 12 and 24 weeks of intervention.;For the measures of characteristics, levels of physical activity, sedentary behavior, sleep and diet will be assessed. Levels of physical activity, sedentary behavior and sleep will be measured using an accelerometer, while eating behavior will be measured using a self-administered questionnaire. The measurements will be used to characterize the sample and will be collected before and after the 24-week intervention. It is expected that the patterns found initially will be maintained in both training groups (aquatic and dry-land).;Changes in capillary blood glucose and systolic and diastolic blood pressure will be checked immediately, 15 and 30 minutes after the first and last sessions of each mesocycle.;As an exploratory result, 24-hour ambulatory blood pressure measurements using ABPM (Dyna-MAPA, Cardios, Brazil) will be collected after the aquatic and land exercise sessions in the 11th and 12th weeks of the training program.;It is expected to find greater reductions in the aquatic training group in the levels of blood markers of the renin-angiotensin system, fasting blood glucose and insulin and in the calculated values of HOMA-IR after 12 and 24 weeks and for creatinine and BDNF after 24 weeks, compared to the terrestrial training group, with the outcomes being assessed through blood sampling. ;We expected to find similar reductions in both combined training groups (aquatic and terrestrial) in blood | — |
Countries
Brazil
Contacts
Public ContactRodrigo Delevatti
Universidade Federal de Santa Catarina
Outcome results
None listed