Diabetes Mellitus, Type 2WBVNCT05968222
Whole Body Vibration and Diabetes Type 2
A study testing Vibration exercise in people with Diabetes Mellitus, Type 2, run by University of Salamanca at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vibration exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2024to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not taking medication for diabetes.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Salamanca
Salamanca, 37007
Vicente Rodríguez Pérez, PhD, 0034923294590 ext. 3162, vicente.rodriguez@usal.es
Rocío Llamas Ramos, PhD
About this study
Official title: Whole Body Vibration Exercise Intervention for Glycemic Control in Type 2 Diabetes Patients
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
- Being tested
- Vibration exercise
- Keywords
- Whole Body Vibration
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Vibration exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 12 weeks post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Feb 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicente Rodríguez Pérez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968222
- Sponsor's protocol ID
- Universidad de Salamanca
- Acronym
- WBV
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12562163Rodriguez-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.
PubMed 28440983del 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.
PubMed 24094494Bonaiuti 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.
PubMed 12137611Behboudi 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.
PubMed 22375223Gusi 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.
PubMed 20235191Sanudo 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.
PubMed 21122265Marazzi 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.
PubMed 31939269Kang 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.
PubMed 27237747Slatkovska 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.
PubMed 22084333Tseng 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.
PubMed 15746473
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Vibration Exercise Intervention for Glycemic Control in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT05968222
- Acronym / sponsor ID
- WBV / Universidad de Salamanca
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Whole Body Vibration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Vibration exerciseParticipants 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. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Not taking medication for diabetes.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration exerciseEach 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 | Experimental group |
Primary outcome
HbA1c.
Time frame: 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
Timed Up and Go 3 meters (TUG 3 m)
Time frame: 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.
10 Meters Walking Test (10 m)
Time frame: baseline and 12 weeks post
On command the subject covers the distance walking as fast as possible, without running.
Five times Sit To Stand (5STS)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 12562163Cardinale 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.
- Background: PubMed 28440983Rodriguez-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.
- Background: PubMed 24094494del 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.
- Background: PubMed 12137611Bonaiuti 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.
- Background: PubMed 22375223Behboudi 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.
- Background: PubMed 20235191Gusi 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.
- Background: PubMed 21122265Sanudo 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.
- Background: PubMed 31939269Marazzi 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.
- Background: PubMed 27237747Kang 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.
- Background: PubMed 22084333Slatkovska 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.
- Background: PubMed 15746473Tseng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration exercise in people with Diabetes Mellitus, Type 2, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicente Rodríguez Pérez, PhD. (0034923244590 ext. 3162, vicente.rodriguez@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c. (time frame: baseline and 12 weeks post). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05968222, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.