Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 13, 2024
Date Accepted: Apr 25, 2025
Whole-body electromyostimulation (WB-EMS) training on glycemic control in people with prediabetes: a study protocol for a randomized controlled pilot-trial
ABSTRACT
Background:
Diabetes prevention programs focus on people with prediabetes because they have a greater risk of developing type 2 diabetes mellitus (T2DM) 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 on WB-EMS on cardiometabolic risk factors including blood glucose control in a population of subjects 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:
Sixty community-dwelling sedentary adults aged 40-65 years with prediabetes will be randomized to one of three 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 subjects in each arm. The WB-EMS training will consist of 1.5×20 min per week. The intervention will last 16 weeks. As a pilot study, our main outcomes concern the number of participants who will be recruited, comply with intervention, and follow up. The primary efficacy outcome of interest includes HbA1c. The intention-to-treat analysis will be conducted with the objective of providing confidence interval estimation of treatment effects.
Results:
The recruitment of study participants started in February 2024. As of October 2024, the recruitment was still ongoing. So far, 42 participants were allocated to the study groups. The anticipated date of recruitment completion is April 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. Clinical Trial: Clinicaltrials.gov ID NCT06188481, registered December 7, 2023, https://clinicaltrials.gov/study/NCT06188481
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