Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Intervention Project for Diabetic Foot Prevention Through the Development of a Vibratory Therapy Program at the National Rehabilitation Institute LGII
In order to determine the effect of whole body vibration on TcPO2 levels in patients with type 2 diabetes, 40 subjects will undertake whole body vibration exercise three times a week for 12 weeks. TcPO2 will be measured before and after the intervention. A second control group with type 2 diabetes will also have TcPO2 levels measured before and after the 12 weeks of the study.
Objective: To determine the effect of whole body vibration exercise on levels of TcPO2
measured in the feet of patients with type 2 diabetes, in order to create recommendations for
prevention of diabetic foot.
Material and Methods: controlled open clinical trial consisting in 2 arms, as follows: 1)
control group under care for type 2 diabetes, and 2) intervention group, who, in addition to
the standard care, will undergo an exercise program of whole body vibration three times a
week, with progressive intensity, for a period of 12 weeks. Partial pressure of
transcutaneous oxygen (TcPO2) will be measured in the feet of the participants at baseline
and after 12 weeks, with 40 patients per group.
Statistical analysis: demographic information of the subjects will be described as arithmetic
means, standard deviation, percentages, frequencies. Comparison between groups will be done
with Student t for independent data or Mann-Whitney U when convenient. Baseline and final
measurements will be compared. inter and intra group comparisons will be made by repeated
measurements. For qualitative values, chi square will be used. Multivariate analysis will be
performed to control for confounding variables. The level of significance will be a value of
0.05.
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