Whole Body Vibration and Diabetes Type 2

NCT05968222 | Unknown

• 1 other identifier: Universidad de Salamanca
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Whole Body Vibration

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Control group

NO INTERVENTION

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 group

EXPERIMENTAL

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

Interventions

Vibration exercise OTHER

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

Experimental group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Not taking medication for diabetes.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, 37007, Spain

Location

Related Publications (11)

• 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.

  PMID: 12562163 BACKGROUND

• 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.

  PMID: 28440983 BACKGROUND

• 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.

  PMID: 24094494 BACKGROUND

• 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.

  PMID: 12137611 BACKGROUND

• 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.

  PMID: 22375223 BACKGROUND

• 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.

  PMID: 20235191 BACKGROUND

• 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.

  PMID: 21122265 BACKGROUND

• 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.

  PMID: 31939269 BACKGROUND

• 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.

  PMID: 27237747 BACKGROUND

• 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.

  PMID: 22084333 BACKGROUND

• 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.

  PMID: 15746473 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Vicente Rodríguez Pérez, PhD.

CONTACT

0034923244590; vicente.rodriguez@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: February 1, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

ES (1)