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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
66
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.
Participants wear the activity tracker on their wrist for the entire 16-week study period.
Participants receive an evidence-based lifestyle education programme (6 x 20 minutes for the period of 3 month).
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, Germany
Change from baseline in HbA1c in %
Assessed via blood sample with finger stick technique
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in lipid profile in mg/dL
Assessed via blood sample with finger stick technique. Includes LDL-cholesterol, HDL-cholesterol and triglycerides
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in waist circumference in cm
Assessed with a measure tape in the centre between the iliac crest and the lower edge of the last palpable rib
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in body composition
Lean body mass and total body fat in kg will be assessed with bioelectrical impedance analysis (BIA)
Time frame: Baseline, after 16 weeks of intervention and after follow-up 32 weeks (only intervention group)
Change from baseline in depressive symptoms
Standardized and validated questionnaire Patient Health Questionnaire consisting of 9 questions on depressive symptoms (PHQ-9) will be used. PHQ-9 is a self-reported questionnaire and is used to assess for the presence and severity of depressive symptoms. Possible score ranges from 0 (no depression) to 27 (severe depression).
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in health-related quality of life
Standardized and validated questionnaire WHO Health-Related Quality of Life (WHOQOL-BREF) consisting fo 26 questions on general quality of life will be used. The tool includes four domains: physical health, psychological health, social relationships, and environmental health; it also contains quality fo life and general health items. Each item of the WHOQOL-BREF is scored from 1 to 5 on a 5-point Likert scale. The scores are then transformed linearly to a 0-100-scale. A higher score indicates a higher quality of life.
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Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in stress
Standardized and validated questionnaire Perceived Stress Scale consisting of 10 questions about stress (PSS-10) will be used. In each questions, subjects are asked how often they felt a certain way on a 5-point scale from 1 for 'never' to 5 for 'very often'. The PSS score indicates levels of perceived stress, whereby higher scores indicate higher stress levels.
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in well-being
Standardized and validated questionnaire Secure Flourish Index (SFI) consisting of 12 questions on general well-being will be used. Each of the questions is assessed on a scale of 0 - 10. The SFI score is obtained by summing the scores from the 12 questions and results in a score from 0 - 120.
Time frame: Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)