Whole Body Vibration and Diabetes Type 2

Diabetes Mellitus, Type 2 Clinical Trial

— WBV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05968222
• Other study ID #: Universidad de Salamanca
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2023
• Source: University of Salamanca
• Contact: Vicente Rodríguez Pérez, PhD.
• Phone: 0034923244590
• Email: vicente.rodriguez[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Spain	University of Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

References & Publications (11)

Behboudi L, Azarbayjani MA, Aghaalinejad H, Salavati M. Effects of aerobic exercise and whole body vibration on glycaemia control in type 2 diabetic males. Asian J Sports Med. 2011 Jun;2(2):83-90. doi: 10.5812/asjsm.34789. — View Citation

Bonaiuti D, Shea B, Iovine R, Negrini S, Robinson V, Kemper HC, Wells G, Tugwell P, Cranney A. Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2002;(3):CD000333. doi: 10.1002/14651858.CD000333. — View Citation

Cardinale M, Bosco C. The use of vibration as an exercise intervention. Exerc Sport Sci Rev. 2003 Jan;31(1):3-7. doi: 10.1097/00003677-200301000-00002. — View 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. — View Citation

Gusi N, Parraca JA, Olivares PR, Leal A, Adsuar JC. Tilt vibratory exercise and the dynamic balance in fibromyalgia: A randomized controlled trial. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1072-8. doi: 10.1002/acr.20180. — View 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. — View Citation

Marazzi S, Kiper P, Palmer K, Agostini M, Turolla A. Effects of vibratory stimulation on balance and gait in Parkinson's disease: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2021 Apr;57(2):254-264. doi: 10.23736/S1973-9087.20.06099-2. Epub 2020 Jan 14. — View Citation

Rodriguez-Reyes RR, Navarro-Zarza JE, Tello-Divicino TL, Parra-Rojas I, Zaragoza-Garcia O, Guzman-Guzman IP. [Detection of cardiovascular risk in healthcare workers on the basis of WHO/JNC 7/ATP III criteria]. Rev Med Inst Mex Seguro Soc. 2017 May-Jun;55(3):300-308. Spanish. — View Citation

Sanudo B, de Hoyo M, Carrasco L, McVeigh JG, Corral J, Cabeza R, Rodriguez C, Oliva A. The effect of 6-week exercise programme and whole body vibration on strength and quality of life in women with fibromyalgia: a randomised study. Clin Exp Rheumatol. 2010 Nov-Dec;28(6 Suppl 63):S40-5. Epub 2010 Dec 22. — View Citation

Slatkovska L, Alibhai SM, Beyene J, Hu H, Demaras A, Cheung AM. Effect of 12 months of whole-body vibration therapy on bone density and structure in postmenopausal women: a randomized trial. Ann Intern Med. 2011 Nov 15;155(10):668-79, W205. doi: 10.7326/0003-4819-155-10-201111150-00005. Erratum In: Ann Intern Med. 2011 Dec 20;155(12):860. — View Citation

Tseng CL, Brimacombe M, Xie M, Rajan M, Wang H, Kolassa J, Crystal S, Chen TC, Pogach L, Safford M. Seasonal patterns in monthly hemoglobin A1c values. Am J Epidemiol. 2005 Mar 15;161(6):565-74. doi: 10.1093/aje/kwi071. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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