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

February 7, 2024 updated by: Dr. Mahdieh Shojaa, University Hospital Tuebingen

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Recruiting
        • University Hospital Tübingen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention group with WB-EMS 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.
Other: whole-body electromyostimulation training
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.
Other: activity tracker
Participants wear the activity tracker on their wrist for the entire 16-week study period.
Other: evidence-based lifestyle education program
Participants receive an evidence-based lifestyle education programme (6 x 20 minutes for the period of 3 month).
Other: Control group with activity tracker and 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.
Other: activity tracker
Participants wear the activity tracker on their wrist for the entire 16-week study period.
Other: evidence-based lifestyle education program
Participants receive an evidence-based lifestyle education programme (6 x 20 minutes for the period of 3 month).
Other: Control group with evidence-based lifestyle education program
The control group completes 6 sessions of an evidence-based lifestyle education program.
Other: evidence-based lifestyle education program
Participants receive an evidence-based lifestyle education programme (6 x 20 minutes for the period of 3 month).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in lipid profile in mg/dL
Time Frame: 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
Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in waist circumference in cm
Time Frame: 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
Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in body composition
Time Frame: 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)
Baseline, after 16 weeks of intervention and after follow-up 32 weeks (only intervention group)
Change from baseline in depressive symptoms
Time Frame: 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).
Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in health-related quality of life
Time Frame: 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.
Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in stress
Time Frame: 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.
Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)
Change from baseline in well-being
Time Frame: 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.
Baseline, after 16 weeks of intervention and follow-up after 32 weeks (only intervention group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Mahdieh Shojaa, Dr., University Hospital Tuebingen/ Institute of Health Sciences/ Population-Based Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WB-EMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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