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

Pre-diabetes Clinical Trial

Official title:

Efficacy of Whole-body Electromyostimulation (WB-EMS) Training on Glycemic Control in People With Prediabetes: a Study Protocol for a Randomized Controlled Pilot-study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188481
• Other study ID #: WB-EMS
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: University Hospital Tuebingen
• Contact: Mahdieh Shojaa, Dr.
• Phone: 07071 29-88815
• Email: mahdieh.shojaa[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot study is to assess the feasibility 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: - Acceptability 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.

Description:

The study is planned as a randomized controlled pilot study. The intervention phase duration is set to 16 weeks. Prior to the study start, all subjects will be screened for their eligibility according to defined inclusion and exclusion criteria. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Germany	University Hospital Tübingen	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in lipid profile in mg/dL	Assessed via blood sample with finger stick technique. Includes LDL-cholesterol, HDL-cholesterol and triglycerides	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Secondary	Change from baseline in waist circumference in cm	Assessed with a measure tape in the centre between the iliac crest and the lower edge of the last palpable rib	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Secondary	Change from baseline in body composition	Lean body mass and total body fat in kg will be assessed with bioelectrical impedance analysis (BIA)	Baseline, after 16 weeks of intervention and after follow-up 32 weeks (only intervention group)
Secondary	Change from baseline in depressive symptoms	Standardized and validated questionnaire Patient Health Questionnaire consisting of 9 questions on depressive symptoms (PHQ-9) will be used. PHQ-9 is a self-reported questionnaire and is used to assess for the presence and severity of depressive symptoms. Possible score ranges from 0 (no depression) to 27 (severe depression).	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Secondary	Change from baseline in health-related quality of life	Standardized and validated questionnaire WHO Health-Related Quality of Life (WHOQOL-BREF) consisting fo 26 questions on general quality of life will be used. The tool includes four domains: physical health, psychological health, social relationships, and environmental health; it also contains quality fo life and general health items. Each item of the WHOQOL-BREF is scored from 1 to 5 on a 5-point Likert scale. The scores are then transformed linearly to a 0-100-scale. A higher score indicates a higher quality of life.	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Secondary	Change from baseline in stress	Standardized and validated questionnaire Perceived Stress Scale consisting of 10 questions about stress (PSS-10) will be used. In each questions, subjects are asked how often they felt a certain way on a 5-point scale from 1 for 'never' to 5 for 'very often'. The PSS score indicates levels of perceived stress, whereby higher scores indicate higher stress levels.	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Secondary	Change from baseline in well-being	Standardized and validated questionnaire Secure Flourish Index (SFI) consisting of 12 questions on general well-being will be used. Each of the questions is assessed on a scale of 0 - 10. The SFI score is obtained by summing the scores from the 12 questions and results in a score from 0 - 120.	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)