Effect of Whole-Body Electromyostimulation Training on Glycemic Control in People With Prediabetes: Protocol for a
Mahdieh Shojaa1, Katharina Knaub1, Norbert Schmitz1
1Department of Population-Based Medicine, University Hospital Tübingen, Tübingen, Germany.
Background:
Diabetes prevention programs focus on people with prediabetes because they have a greater risk of developing type 2 diabetes mellitus than people with normal blood glucose levels. Weight management can reduce this risk. However, in our largely sedentary society, there is less enthusiasm for regular exercise. Whole-body electromyostimulation (WB-EMS) is a training technology that provides exercise-like effects by inducing muscle contractions using electrical currents. There is evidence that local EMS can improve glucose metabolism. Several studies investigated the effect of WB-EMS on cardiometabolic risk factors including blood glucose control in a population of individuals with metabolic syndrome. However, to the best of our knowledge, there is no randomized controlled trial examining the preliminary efficacy of WB-EMS on hemoglobin A1c (HbA1c) levels in individuals with prediabetes.
Objective:
The objective of this randomized controlled trial is to pilot procedures for a randomized controlled trial testing WB-EMS training on glycemic changes in sedentary adults with prediabetes.
Methods:
A total of 60 community-dwelling sedentary adults aged 40-65 years with prediabetes will be randomized to one of 3 arms: WB-EMS + an activity tracker and a lifestyle education program (LEP) focusing on diabetes prevention, an activity tracker and LEP, or LEP only, with 20 individuals in each arm. The WB-EMS training will consist of 1.5×20 minutes per week. The intervention will last 16 weeks. As a pilot study, our main outcomes concern the number of participants who will be recruited, and comply with intervention and follow-up. The primary efficacy outcome of interest includes hemoglobin A1c. The intention-to-treat analysis will be conducted with the objective of providing CI estimation of treatment effects.
Results:
The recruitment of study participants started in February 2024. At the time of submission of this protocol for publication, the recruitment was still ongoing. As of October 2024, a total of 42 participants were allocated to the study groups. The anticipated date of recruitment completion is July 2025.
Conclusions:
The results of this trial will provide valuable evidence for future investigations comparing the efficacy of the WB-EMS intervention with traditional exercise training to improve glycemic control in this population.
Trial Registration:
ClinicalTrials.gov NCT06188481; https://clinicaltrials.gov/study/NCT06188481.
International Registered Report Identifier (Irrid):
DERR1-10.2196/68761.
