Clinical trial NCT06188481: Efficacy of Whole-body Electromyostimulation (WB-EMS) Training in Participants With Pre-diabetes
Official title: Efficacy of Whole-body Electromyostimulation (WB-EMS) Training on Glycemic Control in People With Prediabetes: a Randomized Controlled Pilot-study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-diabetes
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in HbA1c in %
timeFrame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Secondary outcomes:
measure: Change from baseline in lipid profile in mg/dL
timeFrame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
measure: Change from baseline in waist circumference in cm
timeFrame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
measure: Change from baseline in body composition
timeFrame: Baseline, after 16 weeks of intervention and after follow-up 32 weeks (only intervention group)
measure: Change from baseline in depressive symptoms
timeFrame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
measure: Change from baseline in health-related quality of life
timeFrame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
measure: Change from baseline in stress
timeFrame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
measure: Change from baseline in well-being
timeFrame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Tuebingen/ Institute of Health Sciences/ Population-Based Medicine
name: Mahdieh Shojaa, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: 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.
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.
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.