Efficacy of Whole-body Electromyostimulation (WB-EMS) Training in Participants With Pre-diabetes

Not Applicable

Recruiting

Conditions: Pre-diabetes

Interventions: Other: whole-body electromyostimulation training
Other: activity tracker
Other: evidence-based lifestyle education program

Registration Number: NCT06188481

Lead Sponsor: University Hospital Tuebingen

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 60

Inclusion Criteria

community-dwelling sedentary (<20 min physical activity on <3 days/week) men and women aged 40-65 years without Diabetes Type 2
elevated HbA1c levels (5.7%-6.4%),
not functionally impaired (Short Physical Performance Battery (SPPB) ≥10)
signed informed consent
consent to use the WB-EMS and activity tracker

Exclusion Criteria

high-grade arrhythmia/VHF/SM carriers, heart failure >NYHA2, nephropathy (GFR<60),
cognitive impairment
Diabetes Type 2

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group with WB-EMS Training	activity tracker	The Intervention group receives 1.5 times a week WB-EMS training, wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program.
Intervention group with WB-EMS Training	evidence-based lifestyle education program	The Intervention group receives 1.5 times a week WB-EMS training, wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program.
Control group with activity tracker and evidence-based lifestyle education program	activity tracker	The control group wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program.
Intervention group with WB-EMS Training	whole-body electromyostimulation training	The Intervention group receives 1.5 times a week WB-EMS training, wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program.
Control group with activity tracker and evidence-based lifestyle education program	evidence-based lifestyle education program	The control group wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program.
Control group with evidence-based lifestyle education program	evidence-based lifestyle education program	The control group completes 6 sessions of an evidence-based lifestyle education program.

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c in %	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)	Assessed via blood sample with finger stick technique

Secondary Outcome Measures

Name	Time	Method
Change from baseline in depressive symptoms	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)	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).
Change from baseline in well-being	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)	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.
Change from baseline in body composition	Baseline, after 16 weeks of intervention and after follow-up 32 weeks (only intervention group)	Lean body mass and total body fat in kg will be assessed with bioelectrical impedance analysis (BIA)
Change from baseline in lipid profile in mg/dL	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)	Assessed via blood sample with finger stick technique. Includes LDL-cholesterol, HDL-cholesterol and triglycerides
Change from baseline in waist circumference in cm	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)	Assessed with a measure tape in the centre between the iliac crest and the lower edge of the last palpable rib
Change from baseline in health-related quality of life	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)	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.
Change from baseline in stress	Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)	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.

Trial Locations

Locations (1): University Hospital Tübingen
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Tübingen, Baden-Württemberg, Germany