Whole Body Vibration and Diabetes Type 2

Study Overview
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Brief Summary
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Diabetes generates a great impact on society, as well as a concern for health professionals due to its high and increasing prevalence; there are more and more studies that demonstrate the effectiveness of vibration platforms and their benefits at a physiological level. The objective is to analyze the decrease in glycosylated hemoglobin and glycemia levels after the use of whole body vibration platforms and the possible inclusion of this therapeutic option within the usual treatments.The sample will be composed of people diagnosed with Type 2 Diabetes Mellitus in the Plasencia area (Cáceres, Extremadura). Participants will be randomly assigned to the intervention or control group using a randomization list and will follow the inclusion criteria: healthy type 2 diabetics between 50 and 60 years of age and not taking diabetes medication. All participants will undergo a determination of glycosylated hemoglobin, blood pressure, lipid profile, weight and height, and different functional tests such as TUG, 10MMT, 5STS. The experimental group will perform a full body vibration intervention on an oscillating platform for 12 weeks with a weekly frequency of 3 non-consecutive days and a duration of 12 minutes. The exercises will consist of 60 seconds of work and 60 seconds with rest. The control group will carry out their normal life insisting on the importance of glycemic controls before and after their daily physical exercise.

Official Title
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Whole Body Vibration Exercise Intervention for Glycemic Control in Type 2 Diabetes Patients

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Vibration exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not taking medication for diabetes. Exclusion Criteria: Suffer a pathology (such as diabetic retinopathy, diabetic nephropathy), mobility disability and/or comorbidities incompatible with physical exercise and the use of vibration platforms, previous hip or knee surgeries, cognitive impairment and neurological pathology

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Participants in the control group will undergo a determination of glycosylated hemoglobin, blood pressure, lipid profile, weight and height, as well as functional tests such as TUG, 10MWT, 5STS. Subsequently, they will be encouraged to continue their normal life insisting on the importance of glycemic controls before and after their daily physical exercise. In addition to continuing with the dietary measures recommended by their specialist. | |
| Experimental: Experimental group<br>Participants in the intervention group will be subjected to the following tests: At the beginning of the intervention, a determination of glycosylated hemoglobin, blood pressure, lipid profile, weight, height and TUG, 10MWT, 5STS, which will be repeated after 12 weeks of intervention. Before each training session, participants will undergo a basal blood glucose and blood pressure measurement, which will be repeated after the end of the session. Each training session on the vibrating platform is composed of 6 exercises with a duration of 60 seconds with 60-second pauses between exercises and a warm-up exercise. | Other: Vibration exercise<br>* Each training session on the vibrating platform is composed of 6 exercises with a duration of 60 seconds with 60-second pauses between exercises and a warm-up exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c. | HbA1c is a blood test to determine the average level of glucose or sugar in the blood during the last two or three months | baseline and 12 weeks post | 
| Timed Up and Go 3 meters (TUG 3 m) | The subject, seated with his back resting on the back of the chair (without armrests and height 43 cm), at the acoustic command following a five-second countdown, stands up, walks the expected distance, turns around a cone, goes back, turns 360° and sits down again. The test time stops when the subject returns to the starting position and is completely immobile. | baseline and 12 weeks post | 
| 10 Meters Walking Test (10 m) | On command the subject covers the distance walking as fast as possible, without running. | baseline and 12 weeks post | 
| Five times Sit To Stand (5STS) | The subject, seated with his back supported on the chair (without armrests and height 43 cm), on command stands up and sits down five consecutive times, as fast as possible and without using the push of the hands on the quadriceps. | baseline and 12 weeks post | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whole Body Vibration