Pre-diabetes Clinical Trial
Official title:
The Effect of Whole-body Electromyostimulation (WB-EMS) Training Using a Digital Activity Tracker on Glycemic Control in Participants With Pre-diabetes: A Pilot-study
The goal of this pilot study is to assess the feasibility 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: - Acceptability 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.
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. ;
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