An interventional study of Vibration exercise in Diabetes Mellitus, Type 2, sponsored by University of Salamanca. Not yet recruiting at 1 site in Spain. Open to participants aged 50 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by University of Salamanca · Not applicable, Interventional, and Health services research
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Salamanca is the lead sponsor of 110 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
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.
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
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 12 weeks post
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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University of Salamanca