WBV: Whole Body Vibration and Diabetes Type 2

Sponsor
University of Salamanca (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05968222
Collaborator
(none)
40
1
2
3.9
10.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Vibration exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Health Services Research
Official Title:
Whole Body Vibration Exercise Intervention for Glycemic Control in Type 2 Diabetes Patients
Anticipated Study Start Date :
Feb 1, 2024
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

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

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

Outcome Measures

Primary Outcome Measures

  1. HbA1c. [baseline and 12 weeks post]

    HbA1c is a blood test to determine the average level of glucose or sugar in the blood during the last two or three months

  2. Timed Up and Go 3 meters (TUG 3 m) [baseline and 12 weeks post]

    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.

  3. 10 Meters Walking Test (10 m) [baseline and 12 weeks post]

    On command the subject covers the distance walking as fast as possible, without running.

  4. Five times Sit To Stand (5STS) [baseline and 12 weeks post]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Salamanca Salamanca Spain 37007

Sponsors and Collaborators

  • University of Salamanca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Vicente Rodríguez Pérez, Ph.D., University of Salamanca
ClinicalTrials.gov Identifier:
NCT05968222
Other Study ID Numbers:
  • Universidad de Salamanca
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vicente Rodríguez Pérez, Ph.D., University of Salamanca
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2023