Effect of Resistance Training Associated With Whole-Body Vibration in Diabetes

Study Overview
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Brief Summary
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Introduction: Diabetes Mellitus (DM) is an important health condition of the population and its prevalence continues to grow due to population aging, economic development and urbanization. The exercise is an important factor of prevention and control, thereby decreasing the risk of metabolic diseases, cardiovascular diseases and improving the functionality of the patient with diabetes. Objective: Evaluate the response of resistance training associated with whole-body vibration on peripheral circulation and functional performance of elderly with type 2 diabetes. Methods: This is a clinical trial study, controlled, randomized and blinded, which will follow the guidelines established by the Consolidated Standards of Reporting Trials (CONSORT). Patients will be recruited in the light of the eligibility criteria and randomly divided into 3 groups: resistance training associated with whole body vibration (G1), resistance training associated with vibration sham (G2) and control group-guidelines about foot care (GC), establishing 36 treatment sessions, three times a week for the G1 and G2.

Official Title
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Effect of Resistance Training Associated With Whole-Body Vibration Over the Peripheral Circulation and the Functional Performance of the Elderly With Type 2 Diabetes: Randomized Controlled Clinical Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Resistance training associated with vibration
* Other: Resistance training associated with vibration sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present overweight or obese class I, with BMI between 25.00 and 34.99 kg/m2 (WHO, 2009) Be functionally independent Having cognitive ability to respond and perform the exercisesevaluated by Mini-Mental State examination (MMSE), prepared by Folstein et al. (1975) and translation/modification proposed by Lawrence and van Heerden (2006), using as a bridge to cut to illiterate individuals = 19 points (BRAZIL, 2006) Inactive (0 to 5 points) or less active (6 to 11 points) according to the Questionnaire of Habitual Physical Activity (QAFH) Patients without severe foot deformities requiring therapeutic shoes Do not have orthopedic deficiencies No indications of deep vein thrombosis Do not use locomotion auxiliary equipment Exclusion Criteria: Change in the drug program in during the research Performing other physical activity during the training Hypertensive Peaks during treatment

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three groups: resistance training associated with whole body vibration (G1), resistance training associated with vibration sham; (G2) and control group-guidelines about foot care (GC)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance training associated with vibration<br>The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes. | Other: Resistance training associated with vibration<br>* The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration and 5 minutes of slowdown.<br>|
| Sham Comparator: Resistance training associated with sham<br>The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration sham and 5 minutes of slowdown. The vibration sham; will be held with the disconnected platform. A device will be connected producing a noise similar to the sound of the connected platform for a time equivalent to the treatment protocol, since it will not be possible to distinguishing noticeably stimulate vibrator. Participants that will undergo false vibration will not have contact with those who carry out the real treatment. | Other: Resistance training associated with vibration sham<br>* he workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration sham and 5 minutes of slowdown.<br>|
| No Intervention: Control group<br>Will not be submitted to any physical intervention. It continues in your daily life with only monitoring via phone callings. Guidelines about foot care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral circulation | Vascular Doppler ultrasound (UVD) | 12 weeks | 
| Functional performance | Timed Up and Go Test (TUG) | 12 weeks | 
| Peripheral circulation | Infrared Thermography (TI) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static postural alignment | Optoeletrônico system SMART DX100 | 12 weeks | 
| Plantar pressure distribution | Baropodometry | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Blood Flow Velocity, Skin Temperature, Postural Balance, Combined Modality Therapy, Vibration, Resistance Training