Efficacy of Whole-body Electromyostimulation (WB-EMS) Training in Participants With Pre-diabetes
NCT ID: NCT06188481
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2024-01-23
2025-12-17
Brief Summary
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The main goals and questions it aims to answer are:
* Efficacy WB-EMS training in sedentary adults with pre-diabetes,
* Has WB-EMS training positive effects on HbA1c and other biomarkers?
Researchers will compare the intervention group with two control groups to see if WB-EMS training has effects on pre-diabetes.
Detailed Description
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Sixty eligible sedentary individuals with pre-diabetes between the ages of 40 and 65 years will be randomised to one intervention group (n=20) and two control groups (n=20 each).
The main exercise intervention will be conducted via WB-EMS using a medical device approved system (miha bodytec®, Type II, Gersthofen, Germany). Participants in the intervention and one control group will receive an activity tracker (vivosmart 5, Garmin) to measure daily steps during the 16-week intervention phase. All study groups will further receive an evidence-based lifestyle education programme (6 x 20 minutes for 3 months), which provides education, information, and advice to prevent disease progression and improve quality of life and mobility.
During the baseline visit and after 16 weeks endpoint measurements incl. blood biomarkers, cardiometabolic and body composition parameters will be assessed. The intervention group will additionally attend a follow-up visit after 32 weeks and the parameters will be assessed again.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention group with WB-EMS Training
The Intervention group receives 1.5 times a week WB-EMS training, wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program.
whole-body electromyostimulation training
The duration of the intervention is 16 weeks, the training frequency is 1.5 times a week and the exercise program consists of 20 minutes.
activity tracker
Participants wear the activity tracker on their wrist for the entire 16-week study period.
evidence-based lifestyle education program
Participants receive an evidence-based lifestyle education programme (6 x 20 minutes for the period of 3 month).
Control group with activity tracker and evidence-based lifestyle education program
The control group wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program.
activity tracker
Participants wear the activity tracker on their wrist for the entire 16-week study period.
evidence-based lifestyle education program
Participants receive an evidence-based lifestyle education programme (6 x 20 minutes for the period of 3 month).
Control group with evidence-based lifestyle education program
The control group completes 6 sessions of an evidence-based lifestyle education program.
evidence-based lifestyle education program
Participants receive an evidence-based lifestyle education programme (6 x 20 minutes for the period of 3 month).
Interventions
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whole-body electromyostimulation training
The duration of the intervention is 16 weeks, the training frequency is 1.5 times a week and the exercise program consists of 20 minutes.
activity tracker
Participants wear the activity tracker on their wrist for the entire 16-week study period.
evidence-based lifestyle education program
Participants receive an evidence-based lifestyle education programme (6 x 20 minutes for the period of 3 month).
Eligibility Criteria
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Inclusion Criteria
* elevated HbA1c levels (5.7%-6.4%),
* not functionally impaired (Short Physical Performance Battery (SPPB) ≥10)
* signed informed consent
* consent to use the WB-EMS and activity tracker
Exclusion Criteria
* cognitive impairment
* Diabetes Type 2
40 Years
65 Years
ALL
Yes
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Dr. Mahdieh Shojaa
Principal Investigator
Principal Investigators
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Mahdieh Shojaa, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Tuebingen/ Institute of Health Sciences/ Population-Based Medicine
Locations
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University Hospital Tübingen
Tübingen, Baden-Wurttemberg, Germany
Countries
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References
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van Buuren F, Horstkotte D, Mellwig KP, Frund A, Vlachojannis M, Bogunovic N, Dimitriadis Z, Vortherms J, Humphrey R, Niebauer J. Electrical Myostimulation (EMS) Improves Glucose Metabolism and Oxygen Uptake in Type 2 Diabetes Mellitus Patients--Results from the EMS Study. Diabetes Technol Ther. 2015 Jun;17(6):413-9. doi: 10.1089/dia.2014.0315. Epub 2015 Mar 3.
Miyamoto T, Fukuda K, Kimura T, Matsubara Y, Tsuda K, Moritani T. Effect of percutaneous electrical muscle stimulation on postprandial hyperglycemia in type 2 diabetes. Diabetes Res Clin Pract. 2012 Jun;96(3):306-12. doi: 10.1016/j.diabres.2012.01.006. Epub 2012 Jan 30.
Miyamoto T, Iwakura T, Matsuoka N, Iwamoto M, Takenaka M, Akamatsu Y, Moritani T. Impact of prolonged neuromuscular electrical stimulation on metabolic profile and cognition-related blood parameters in type 2 diabetes: A randomized controlled cross-over trial. Diabetes Res Clin Pract. 2018 Aug;142:37-45. doi: 10.1016/j.diabres.2018.05.032. Epub 2018 May 24.
Coughlin SS, Stewart J. Use of Consumer Wearable Devices to Promote Physical Activity: A Review of Health Intervention Studies. J Environ Health Sci. 2016 Nov;2(6):10.15436/2378-6841.16.1123. doi: 10.15436/2378-6841.16.1123. Epub 2016 Nov 30.
vanSonnenberg E, Wroblicka JT, D'Agostino HB, Mathieson JR, Casola G, O'Laoide R, Cooperberg PL. Symptomatic hepatic cysts: percutaneous drainage and sclerosis. Radiology. 1994 Feb;190(2):387-92. doi: 10.1148/radiology.190.2.8284385.
Ellingson LD, Lansing JE, DeShaw KJ, Peyer KL, Bai Y, Perez M, Phillips LA, Welk GJ. Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Healthy Adults' Activity Levels: Randomized Intervention. JMIR Mhealth Uhealth. 2019 Feb 14;7(2):e10988. doi: 10.2196/10988.
Shojaa M, Knaub K, Schmitz N, Niess AM, Munz B, Rau S, Feit V, Mphepo W, Dingler R, Kemmler W. Effect of Whole-Body Electromyostimulation Training on Glycemic Control in People With Prediabetes: Protocol for a Pilot Randomized Controlled Trial Study. JMIR Res Protoc. 2025 Jun 24;14:e68761. doi: 10.2196/68761.
Other Identifiers
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WB-EMS
Identifier Type: -
Identifier Source: org_study_id