Efficacy of Whole-body Electromyostimulation (WB-EMS) Training in Participants With Pre-diabetes

NCT06188481 | Completed

• 1 other identifier: WB-EMS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to assess the efficacy of the intervention (WB-EMS Training) in a sedentary group of adults with pre-diabetes and to estimate the potential effect sizes. 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.

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c in %

  Assessed via blood sample with finger stick technique

  Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)

Secondary Outcomes (7)

• Change from baseline in lipid profile in mg/dL

  Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)

• Change from baseline in waist circumference in cm

  Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)

• Change from baseline in body composition

  Baseline, after 16 weeks of intervention and after follow-up 32 weeks (only intervention group)

• Change from baseline in depressive symptoms

  Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)

• Change from baseline in health-related quality of life

  Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)

Study Arms (3)

Intervention group with WB-EMS Training

OTHER

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.

Other: whole-body electromyostimulation training; Other: activity tracker; Other: evidence-based lifestyle education program

Control group with activity tracker and evidence-based lifestyle education program

OTHER

The control group wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program.

Other: activity tracker; Other: evidence-based lifestyle education program

Control group with evidence-based lifestyle education program

OTHER

The control group completes 6 sessions of an evidence-based lifestyle education program.

Other: evidence-based lifestyle education program

Interventions

evidence-based lifestyle education program OTHER

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; Control group with evidence-based lifestyle education program; Intervention group with WB-EMS Training

whole-body electromyostimulation training OTHER

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.

Intervention group with WB-EMS Training

activity tracker OTHER

Participants wear the activity tracker on their wrist for the entire 16-week study period.

Control group with activity tracker and evidence-based lifestyle education program; Intervention group with WB-EMS Training

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• community-dwelling sedentary (\<20 min physical activity on \<3 days/week) men and women aged 40-65 years without Diabetes Type 2
• 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

You may not qualify if:

• high-grade arrhythmia/VHF/SM carriers, heart failure \>NYHA2, nephropathy (GFR\<60),
• cognitive impairment
• Diabetes Type 2

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (14)

• Hoshiai M, Ochiai K, Tamura Y, Tsurumi T, Terashima M, Tamiya H, Maeno E, Mizuguchi S, Tomoe T, Kawabe A, Uema A, Ueno A, Sugiyama T, Horie Y, Sugimura H, Koike R, Yasu T. Effects of whole-body neuromuscular electrical stimulation device on hemodynamics, arrhythmia, and sublingual microcirculation. Heart Vessels. 2021 Jun;36(6):844-852. doi: 10.1007/s00380-020-01755-1. Epub 2021 Feb 6.

  PMID: 33547929 BACKGROUND

• Watanabe K, Yoshida T, Ishikawa T, Kawade S, Moritani T. Effect of the Combination of Whole-Body Neuromuscular Electrical Stimulation and Voluntary Exercise on Metabolic Responses in Human. Front Physiol. 2019 Mar 20;10:291. doi: 10.3389/fphys.2019.00291. eCollection 2019.

  PMID: 30949069 BACKGROUND

• Kemmler W, Weissenfels A, Willert S, Shojaa M, von Stengel S, Filipovic A, Kleinoder H, Berger J, Frohlich M. Efficacy and Safety of Low Frequency Whole-Body Electromyostimulation (WB-EMS) to Improve Health-Related Outcomes in Non-athletic Adults. A Systematic Review. Front Physiol. 2018 May 23;9:573. doi: 10.3389/fphys.2018.00573. eCollection 2018.

  PMID: 29875684 BACKGROUND

• Kemmler W, von Stengel S, Kohl M, Rohleder N, Bertsch T, Sieber CC, Freiberger E, Kob R. Safety of a Combined WB-EMS and High-Protein Diet Intervention in Sarcopenic Obese Elderly Men. Clin Interv Aging. 2020 Jun 24;15:953-967. doi: 10.2147/CIA.S248868. eCollection 2020.

  PMID: 32612355 BACKGROUND

• Kemmler W, Bebenek M, Engelke K, von Stengel S. Impact of whole-body electromyostimulation on body composition in elderly women at risk for sarcopenia: the Training and ElectroStimulation Trial (TEST-III). Age (Dordr). 2014 Feb;36(1):395-406. doi: 10.1007/s11357-013-9575-2. Epub 2013 Aug 16.

  PMID: 23949160 BACKGROUND

• Kemmler W, Kohl M, Freiberger E, Sieber C, von Stengel S. Effect of whole-body electromyostimulation and / or protein supplementation on obesity and cardiometabolic risk in older men with sarcopenic obesity: the randomized controlled FranSO trial. BMC Geriatr. 2018 Mar 9;18(1):70. doi: 10.1186/s12877-018-0759-6.

  PMID: 29523089 BACKGROUND

• Kemmler W, von Stengel S. Whole-body electromyostimulation as a means to impact muscle mass and abdominal body fat in lean, sedentary, older female adults: subanalysis of the TEST-III trial. Clin Interv Aging. 2013;8:1353-64. doi: 10.2147/CIA.S52337. Epub 2013 Oct 7.

  PMID: 24130433 BACKGROUND

• 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.

  PMID: 25734937 BACKGROUND

• 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.

  PMID: 22296854 BACKGROUND

• 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.

  PMID: 29802953 BACKGROUND

• 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.

  PMID: 28428979 BACKGROUND

• Leskinen T, Suorsa K, Tuominen M, Pulakka A, Pentti J, Loyttyniemi E, Heinonen I, Vahtera J, Stenholm S. The Effect of Consumer-based Activity Tracker Intervention on Physical Activity among Recent Retirees-An RCT Study. Med Sci Sports Exerc. 2021 Aug 1;53(8):1756-1765. doi: 10.1249/MSS.0000000000002627.

  PMID: 34261997 BACKGROUND

• 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.

  PMID: 30762582 BACKGROUND

• 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.

  PMID: 40554784 DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Mahdieh Shojaa, Dr.

  University Hospital Tuebingen/ Institute of Health Sciences/ Population-Based Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 3, 2024
• Study Start: January 23, 2024
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)