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Whole-body Electromyostimulation in Inpatient Rehabilitation

Evaluation of Whole-body Electromyostimulation (WB-EMS) in the Context of Inpatient Rehabilitation of Cardiological and Orthopedic Patients by Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03767088
Acronym
GERKO
Enrollment
134
Registered
2018-12-06
Start date
2019-01-01
Completion date
2020-03-15
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

WB-EMS, rehabilitation, sarcopenia

Brief summary

Based on various studies, scientific evidence has proven the effectiveness of whole-body electromyostimulation (WB-EMS) on parameters such as increased physiological performance and body composition. As a pilot project, the aim of the study is to determine the effect of additional WB-EMS as part of the inpatient four-week rehabilitation of sarcopenic subjects.

Detailed description

The loss of muscle mass in the age-associated process (sarcopenia) is a common indication in the field of orthopedic and cardiac rehabilitation, which may also be reinforced by previous immobilization and disuse of the muscles (atrophy of muscle). Sarcopenia is defined as 2 standard deviations of average of the same sex in middle adult life. The present project focuses on the sarcopenia definition of the Foundation for the National Institutes of Health (FNIH). Their limits are \< 0.789 (men) and \< 0.512 (women) and are calculated by adding the absolute muscle mass of the extremities divided by the body mass index (BMI). Due to reduced muscle mass and thus limited strength / performance, the implementation of conventional training tools with regard to generate corresponding intensities is no longer possible, or in persons with additional cardiac or orthopedic restrictions heavily limited. In view of the existing indications, the alternative training technology whole-body electromyostimulation (WB-EMS) is an adequate training tool for the rehabilitation process. The time-saving (max 20 minutes per training session) and effective training method is characterized by low orthopedic and cardiac stress. Thus, WB-EMS combines both relevant aspects of a joint-friendly training with effects on muscle mass and functionality. Through the simultaneous activation of up to 10 muscle regions with corresponding, subjectively decidedly adjustable intensity per muscle group, up to 2,800 cm2 can be addressed. Synchronized to a motion video, the participants perform light physical exercises in parallel to the current pulses. The aim of the study is, to evaluate the effect of additional WB-EMS during a 4-week period of inpatient rehabilitation, comparing 3 groups: 1. WB-EMS, stimulating 8 muscle groups (legs,arms, core, gluteal region) 2. partial-WB-EMS, just stimulating the lower extremities (legs, gluteal region) 3. control, just performing the functional, mainly eccentric motion pattern without stimulation

Interventions

DEVICEWB-EMS

whole body electromyostimulation

OTHER(synchronized) Training program without WB-EMS

20 min of pronounced eccentric movement patterns

Sponsors

Prof. Dr. Frank Mooren
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

prospective randomized controlled parallel group design

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. skeletal muscle index (SMI) \< 0,789 (men); \< 0,512 (women) 2. A general state of good health 3. Medically approved unrestricted sports participation as shown by diagnostic performance test 4. Willingness to provide signed informed consent

Exclusion criteria

1. Post-coronary artery bypass graft (ACVB) surgery in the last 3 months 2. Condition after pacemaker and defibrillator implantation 3. renal insufficiency from stage 3a 4. epilepsy 5. feverish diseases or infectious diseases 6. Taking medicines the affect muscle metabolism 7. severe neurological disorders 8. Skin injuries in the area of electrodes

Design outcomes

Primary

MeasureTime frameDescription
(isometric) muscle strength of arms, legs and trunk (extenstion)4 weeksisometric strength \[Nm\] (DIERs Myoline professional, DIERs International GmbH)
muscle function4 weekschair rise test \[repetitions; n\]
muscle function / submaximal performance test4 weeks6 minute walking test \[distance; m\]

Secondary

MeasureTime frameDescription
blood-sample: high-density lipoprotein (HDL)4 weeksblood-sample
blood-sample: low-density lipoprotein (LDL)4 weeksblood-sample
blood-sample: Crea/glomerular filtration rate (GfR)4 weeksblood-sample
blood-sample: glutamate oxaloacetate transaminase (GOT)4 weeksblood-sample
blood-sample: glutamic pyruvic transaminase (GPT)4 weeksblood-sample
blood-sample: gamma-glutamyl transpeptidase (GGT)4 weeksblood-sample
muscle mass via multifrequency bioimpedance analysis4 weeksvia multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)
blood-sample: myoglobin4 weeksblood-sample
blood-sample: sodium4 weeksblood-sample
potassium4 weeksblood-sample
life quality4 weeksquestionnaire: Short Form 36 Health Survey (SF-36)
self-efficacy4 weeksquestionnaire: Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
activities of daily living4 weeksquestionnaire: Late-Life Function & Disability Instrument (LLFDI)
blood-sample: creatine kinase (CK)4 weeksblood-sample
body fat via multifrequency bioimpedance analysis4 weeksvia multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)
blood-sample: triglycerides4 weeksblood-sample

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026