NCT06188481

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
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.
OTHER	activity tracker	Participants wear the activity tracker on their wrist for the entire 16-week study period.
OTHER	evidence-based lifestyle education program	Participants receive an evidence-based lifestyle education programme (6 x 20 minutes for the period of 3 month).

Timeline

• Start date: 2024-01-23
• Primary completion: 2025-12-17
• Completion: 2025-12-17
• First posted: 2024-01-03
• Last updated: 2025-12-24

Locations

1 site across 1 country: Germany