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

University Hospital Tuebingen

Status: Completed

Conditions: Pre-diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06188481

WB-EMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 3 patient groups

Intervention group with WB-EMS Training

Other group

Description:

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.

Treatment:

Other: activity tracker

Other: evidence-based lifestyle education program

Other: whole-body electromyostimulation training

Control group with activity tracker and evidence-based lifestyle education program

Other group

Description:

The control group wears an activity tracker for 16 weeks and completes 6 sessions of an evidence-based lifestyle education program.

Treatment:

Other: activity tracker

Other: evidence-based lifestyle education program

Control group with evidence-based lifestyle education program

Other group

Description:

The control group completes 6 sessions of an evidence-based lifestyle education program.

Treatment:

Other: evidence-based lifestyle education program