Shojaa Mahdieh, Knaub Katharina, Schmitz Norbert, Nieß Andreas Michael, Munz Barbara, Rau Sarah, Feit Viktoria, Mphepo Wallen, Dingler Rahel, Kemmler Wolfgang
Department of Population-Based Medicine, University Hospital Tübingen, Tübingen, Germany.
Department of Sports Medicine, University Hospital Tübingen, Tübingen, Germany.
JMIR Res Protoc. 2025 Jun 24;14:e68761. doi: 10.2196/68761.
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 A (HbA) levels in individuals with prediabetes.
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.
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 A. The intention-to-treat analysis will be conducted with the objective of providing CI estimation of treatment effects.
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.
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.
ClinicalTrials.gov NCT06188481; https://clinicaltrials.gov/study/NCT06188481.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/68761.
糖尿病预防项目主要针对糖尿病前期人群，因为他们患2型糖尿病的风险高于血糖水平正常的人。体重管理可以降低这种风险。然而，在我们这个久坐不动的社会中，人们对定期锻炼的热情较低。全身肌电刺激（WB-EMS）是一种训练技术，通过电流诱导肌肉收缩来产生类似运动的效果。有证据表明局部肌电刺激可以改善葡萄糖代谢。几项研究调查了WB-EMS对代谢综合征人群的心血管代谢危险因素（包括血糖控制）的影响。然而，据我们所知，尚无随机对照试验研究WB-EMS对糖尿病前期个体血红蛋白A（HbA）水平的初步疗效。
本随机对照试验的目的是为一项随机对照试验制定流程，该试验将测试WB-EMS训练对久坐不动的糖尿病前期成年人体内血糖变化的影响。
总共60名年龄在40 - 65岁、患有糖尿病前期且居住在社区的久坐不动成年人将被随机分为3组之一：WB-EMS + 活动追踪器以及专注于糖尿病预防的生活方式教育项目（LEP）、活动追踪器和LEP，或仅LEP，每组20人。WB-EMS训练将包括每周1.5×20分钟。干预将持续16周。作为一项试点研究，我们的主要结果涉及将被招募、遵守干预和随访的参与者数量。感兴趣的主要疗效结果包括血红蛋白A。将进行意向性分析，目的是提供治疗效果的置信区间估计。
研究参与者的招募于2024年2月开始。在提交本方案以供发表时，招募仍在进行中。截至2024年10月，共有42名参与者被分配到研究组。预计招募完成日期为2025年7月。
本试验的结果将为未来比较WB-EMS干预与传统运动训练改善该人群血糖控制疗效的研究提供有价值的证据。
ClinicalTrials.gov NCT06188481；https://clinicaltrials.gov/study/NCT06188481。
国际注册报告识别码（IRRID）：DERR1-10.2196/68761。
