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Whole Body Vibration and Diabetes Type 2 (WBV)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vibration exercise
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Whole Body Vibration

Eligibility Criteria

50 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Salamanca

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.
10 Meters Walking Test (10 m)
On command the subject covers the distance walking as fast as possible, without running.
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.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2023
Last Updated
July 21, 2023
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT05968222
Brief Title
Whole Body Vibration and Diabetes Type 2
Acronym
WBV
Official Title
Whole Body Vibration Exercise Intervention for Glycemic Control in Type 2 Diabetes Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2024 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Whole Body Vibration

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Vibration exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
HbA1c.
Description
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
Title
Timed Up and Go 3 meters (TUG 3 m)
Description
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
Title
10 Meters Walking Test (10 m)
Description
On command the subject covers the distance walking as fast as possible, without running.
Time Frame
baseline and 12 weeks post
Title
Five times Sit To Stand (5STS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vicente Rodríguez Pérez, PhD.
Phone
0034923244590
Ext
3162
Email
vicente.rodriguez@usal.es
Facility Information:
Facility Name
University of Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Rodríguez Pérez, PhD
Phone
0034923294590
Ext
3162
Email
vicente.rodriguez@usal.es
First Name & Middle Initial & Last Name & Degree
Rocío Llamas Ramos, PhD
First Name & Middle Initial & Last Name & Degree
Inés Llamas Ramos, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
12562163
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
24094494
Citation
del Pozo-Cruz B, Alfonso-Rosa RM, del Pozo-Cruz J, Sanudo B, Rogers ME. Effects of a 12-wk whole-body vibration based intervention to improve type 2 diabetes. Maturitas. 2014 Jan;77(1):52-8. doi: 10.1016/j.maturitas.2013.09.005. Epub 2013 Sep 18.
Results Reference
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PubMed Identifier
12137611
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
31939269
Citation
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Results Reference
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Citation
Kang H, Lu J, Xu G. The effects of whole body vibration on muscle strength and functional mobility in persons with multiple sclerosis: A systematic review and meta-analysis. Mult Scler Relat Disord. 2016 May;7:1-7. doi: 10.1016/j.msard.2016.02.008. Epub 2016 Feb 8.
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PubMed Identifier
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Citation
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Whole Body Vibration and Diabetes Type 2

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