Acute Whole Body Vibration Change the Glycemic and Lactate Levels

Study Overview
=================
Brief Summary
-----------------
The type II diabetes is characterized by high levels of blood glucose followed by excessive insulin release so that the target cells become less sensitive and develop insulin resistance, maintaining hyperglycemic levels. The Whole body vibration session may improve the glucose metabolism in diabetic patients by reducing the peripheral blood sugar. Ten healthy elderly women and eight diabetic elderly women were allocated into two groups, and have made an acute whole body session.

Official Title
-----------------
Acute Whole Body Vibration Decrease the Glucose Levels in Elderly Diabetic Women

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: whole body vibration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elderly between 60 to 74 years, sedentary according the International Physical Activity Questionnaire (IPAQ- short form) For diabetic group, were considered who those medical diagnoses of type II diabetes for at least 02 complete years, who had used only oral hypoglycemic agents of biguanides class (Metformin extended release - XR) in dosage between 500 to 850 mg. For healthy elderly group were considered elderly women without self-reported diseases Exclusion Criteria: diabetic volunteers who have ingested the breakfast less than 02 hours or more than 03 hours and those who have taken Metformin less than 02 hours before the intervention. For all volunteers, the complementary exclusion criteria were: the current or past smoking or alcoholic habits; the cardiovascular, liver or neuromuscular diseases; subjects with prior labyrinthitis or embolic events; who have had any surgery in last year; volunteers with metallic prosthesis as pacemaker, pins or plates; volunteers with advanced osteoporosis; which had difficulties during the evaluation or acute protocol.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: healthy elderly<br>healthy elderly were use the Whole body vibration intervention during 10 minutes | Device: whole body vibration<br>* whole body vibration training on a vibrating platform with healthy elderly and diabetic elderly<br>|
| Experimental: diabetic elderly<br>diabetic elderly were use the Whole body vibration intervention during 10 minutes | Device: whole body vibration<br>* whole body vibration training on a vibrating platform with healthy elderly and diabetic elderly<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glucose levels | A digital puncture with disposable lancets was collected a peripheral blood drop in the specific strip for the home glucose monitoring AccuChek Active® (Roche Diagnostics GmbH, Mannheim, Germany) according to International Organization for Standardization (ISO) recommendations in 2013 (11). | before and immediately after the 10 minute intervention | 
| Changes in lactate levels | Another peripheral blood drop was collected from the same digital puncture with disposable lancets and put in the specific strip for to check the seric blood lactate, which was analyzed by a portable lactimeter Accutrend Plus ® (Roche Accutrend Plus, New York, USA). | before and immediately after the 10 minute intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peripheral oxygen saturation (SpO2) | measured with a digital oximeter Onyx (Nonim, model 9500, USA) | before and immediately after the 10 minute intervention | 
| heart rate (HR) | measured with a digital oximeter Onyx (Nonim, model 9500, USA) | before and immediately after the 10 minute intervention | 
| Borg's Rating of Perceived Exertion Scale (RPE) or Modified Borg Scale | visual scale that measure the perceived exertion in muscle or dyspnoea, measuring values between 0 at 10 | before and immediately after the 10 minute intervention |