Effects of two water-based exercise programs on health parameters in adults with Type 2 Diabetes

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: This is a randomized clinical trial, single‐blind, that aims to evaluate the effects of two programs of water‐based combined training on health parameters of adults with type 2 diabetes. The sample will be composed of 52 individuals with type 2 diabetes, of both sexes, aged between 40 and 65 years, who will be randomized between two groups: water‐based combined training performed in two weekly sessions (n=26) and water‐based combined training performed in three weekly sessions (n=26). The training will be performed in parallel. The sample will be distributed in the two intervention groups by randomization process with a 1:1 ratio, with stratification by se X(female and male) and insulin users (users and non‐users), through a random list generated by computer (RAND function, Microsoft Excel). This procedure will be performed by a blinded researcher after completing the pre‐training assessments. The training will last 16 weeks with a weekly frequency of two and three sessions, respectively (approximately 50 minutes each). Biochemical, cardiorespiratory fitness, muscle strength and functional mobility assessments will be performed before and after the 16 weeks of training. CONDITION: C18.452.394.750 Diabetes Mellitus, Type 2 PRIMARY OUTCOME: It is expected to find improvements in the blood levels of glycated hemoglobin (HbA1c). The collection of blood samples will be performed after a 12‐hour fast. Blood concentration analyses will be evaluated by the colorimetric enzymatic method using a biochemical analyzer (Cobas C111 – Roche). The mean differences of the groups between pre‐ and post‐training periods and between the two training groups will be analyzed. In addition, the 1% change will be used to assess clinically significant changes in individual responsiveness to training. SECONDARY OUTCOME: It is expected to find a reduction in resting heart rate values. A POLAR FT1TM heart rate monitor will be used after a 15‐minute rest. The mean differences of the groups between pre‐ and post‐training periods and between the two training groups will be analyzed. It is expected to find an improvement in functional mobility. For this, the timed up‐and‐go test will be performed, and the lowest time of three attempts will be recorded. The average differences of the groups between the pre and post‐training periods and between the two training groups will be analyzed. It is expected to find an increase in handgrip strength. A handgrip strength test will be performed using a portable dynamometer (SAEHAN). The average differences of the groups between the pre and post‐training periods and between the two training groups will be analyzed. It is expected to find an increase in lower limb muscle strength through the five times sit‐to‐stand test. The time for performing the five repetitions will be recorded, from the initial sitting position to the final position with the body extended at the end of the fifth repetition. The mean differences of the groups between the pre and post‐training periods and between the two training groups will be analyzed. It is expected to find an increase in the maximum strength of lower limbs through the 1‐repetition maximum test (1RM) of knee extension. The average differences of the groups between the pre and post‐training periods and between the two training groups will be analyzed. It is expected to find an increase in the maximum strength of upper limbs through the 1‐repetition maximum test (1RM) of elbow flexion. The average differences of the groups between the pre and post‐training periods and between the two training groups will be analyzed. It is expected to find an increase in the muscular resistance of lower limbs. To determine the muscular resistance strength, the maximum number of repetitions performed with 60% of 1RM of knee extension will be considered. The average differences of the groups between the pre and post‐training periods and between the two training groups will be analyzed. It is expected to find an increase in the muscular resistance of upper limbs. To determine the muscular resistance strength, the maximum number of repetitions performed with 60% of 1RM of elbow flexion will be considered. The average differences of the groups between the pre and post‐training periods and between the two training groups will be analyzed. It is expected to find improvement in insulin resistance. The assessment of insulin resistance homeostasis (HOMA‐IR) will be performed using the following formula: HOMA‐IR: [fasting glucose (mmol/l) * fasting insulin (mmol/l)]/22.5. The mean differences of the groups between the pre and post‐training periods and between the two training groups will be analyzed. It is expected to find improvements in the blood levels of C‐reactive protein. The collection of blood samples will be performed after a 12‐hour fast. Blood concentration analyses will be evaluated by the colorimetric enzymatic method using a biochemical analyzer (Cobas C111 – Roche). The mean differences of the groups between pre‐ and post‐training periods and between the two training groups will be analyzed. It is expected to find improvements in the blood levels of fasting glucose. The collection of blood samples will be performed after a 12‐hour fast. Blood concentration analyses will be evaluated by the colorimetric enzymatic method using a biochemical analyzer (Cobas C111 – Roche). The mean differences of the groups between pre‐ and post‐training periods and between the two training groups will be analyzed. It is expected to find improvements in the blood levels of fasting insulin. The collection of blood samples will be performed after a 12‐hour fast. Blood concentration analyses will be evaluated by the ELISA method. The mean differences of the groups between pre‐ and post‐training periods and between the two training groups will be analyzed. It is expected to find improvements in the blood levels of high‐density lipoprotein (HDL). The collection of blood samples will be performed after a 12‐hour fast. Blood concentration analyses will be evaluated by the colorimetric enzymatic method using a biochemical analyzer (Cobas C111 – Roche). The mean differences of the groups between pre‐ and post‐training periods and between the two training groups will be analyzed. It is expected to find improvements in the blood levels of low‐density lipoprotein levels (LDL). LDL concentrations will be estimated by the Friedewald formula (1972). The mean differences of the groups between pre‐ and post‐training periods and between the two training groups will be analyzed. It is expected to find improvements in the blood levels of total cholesterol. The collection of blood samples will be performed after a 12‐hour fast. Blood concentration analyses will be evaluated by the colorimetric enzymatic method using a biochemical analyzer (Cobas C111 – Roche). The mean differences of the groups between pre‐ and post‐training periods and between the two training groups will be analyzed. It is expected to find improvements in the blood levels of triglycerides. The collection of blood samples will be performed after a 12‐hour fast. Blood concentration analyses will be evaluated by the colorimetric enzymatic method using a biochemical analyzer (Cobas C111 – Roche). The mean differences of the groups between pre‐ and post‐training periods and between the two training groups will be analyzed. It is expected to find improvements in the diastolic blood pressure levels (DBP). A MAPA oscillometric blood pressure monitor (MEDITECH) will be used after a 15‐minute rest. The mean differences of the groups between pre‐ and post‐training periods and between the two training groups will be analyzed. It is expected to find improvements in the systolic blood pressure levels (SBP). A MAPA oscillometric blood pressure monitor (MEDITECH) will be used after a 15‐minute rest. The mean differences of the groups between pre‐ and post‐training periods and between the two training groups will be analyzed. INCLUSION CRITERIA: Men and women with type 2 diabetes mellitus; aged between 40 and 65 years; who are undergoing medical treatment using oral hypoglycemic agents and/or insulin; who are not practicing systematic physical exercise in the three months prior to the study
Epistemonikos ID: 0c491da978b77fc298808b01096360a003bb50dd
First added on: Aug 26, 2024