Effect of Whole-body Vibration on TcPO2 (WBV)
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|ClinicalTrials.gov Identifier: NCT03957811|
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Other: Whole body Vibration exercise||Phase 3|
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, standrad 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||There will be two parallel groups. One will receive the standard treatment for diabetes, and the other will receive standard treatment plus sessions of vibration exercise therapy.|
|Masking:||None (Open Label)|
|Official Title:||Intervention Project for Diabetic Foot Prevention Through the Development of a Vibratory Therapy Program at the National Rehabilitation Institute LGII|
|Actual Study Start Date :||April 4, 2017|
|Estimated Primary Completion Date :||December 20, 2019|
|Estimated Study Completion Date :||June 2020|
No Intervention: Controls
Subjects under treatment for diabetes will receive the standard treatment for their condition.
Subjects under treatment for diabetes not diagnosed for diabetic foot will receive the standard treatment plus exercise on a vibrator platform for a period of 12 weeks.
Other: Whole body Vibration exercise
Intervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks.
- Effect of whole body vibration on TcPO2 levels [ Time Frame: 12 weeks ]To know the effect of whole body vibration on TcPO2 levels measured in the foot in patients with type 2 diabetes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957811
|Contact: Gerardo Rodríguez Reyes, MS||+525559991000 ext firstname.lastname@example.org|
|Instituto Nacional de Rehabilitacion||Recruiting|
|Mexico City, DF, Mexico, 14389|
|Contact: Gerardo Rodriguez Reyes, MS 5559991000 ext 13221 email@example.com|