Whole-body Electromyostimulation in Inpatient Rehabilitation

Study Overview
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Brief Summary
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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
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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: WB-EMS, stimulating 8 muscle groups (legs,arms, core, gluteal region) partial-WB-EMS, just stimulating the lower extremities (legs, gluteal region) control, just performing the functional, mainly eccentric motion pattern without stimulation

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

Conditions
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Sarcopenia

Intervention / Treatment
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* Device: WB-EMS
* Other: (synchronized) Training program without WB-EMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: skeletal muscle index (SMI) < 0,789 (men); < 0,512 (women) A general state of good health Medically approved unrestricted sports participation as shown by diagnostic performance test Willingness to provide signed informed consent Exclusion Criteria: Post-coronary artery bypass graft (ACVB) surgery in the last 3 months Condition after pacemaker and defibrillator implantation renal insufficiency from stage 3a epilepsy feverish diseases or infectious diseases Taking medicines the affect muscle metabolism severe neurological disorders Skin injuries in the area of electrodes
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized controlled parallel group design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WB-EMS<br>1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session stimulation of 8 muscle groups (legs, gluteal region, core, arms) while performing slight eccentric pronounced physiological movement patterns parameters: 85 Hz, 350ms, intermittent, 4 s load vs 4 s regeneration | Device: WB-EMS<br>* whole body electromyostimulation<br>|
| Active Comparator: partial WB-EMS<br>1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session stimulation of 2 muscle groups (legs, gluteal region; lower extremities) while performing slight eccentric pronounced physiological movement patterns parameters: 85 Hz, 350ms, intermittent, 4 s load vs 4 s regeneration | Device: WB-EMS<br>* whole body electromyostimulation<br>|
| Sham Comparator: control<br>active sham comparator: 1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session performing slight eccentric pronounced physiological movement patterns | Other: (synchronized) Training program without WB-EMS<br>* 20 min of pronounced eccentric movement patterns<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (isometric) muscle strength of arms, legs and trunk (extenstion) | isometric strength [Nm] (DIERs Myoline professional, DIERs International GmbH) | 4 weeks | 
| muscle function | chair rise test [repetitions; n] | 4 weeks | 
| muscle function / submaximal performance test | 6 minute walking test [distance; m] | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle mass via multifrequency bioimpedance analysis | via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea) | 4 weeks | 
| body fat via multifrequency bioimpedance analysis | via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea) | 4 weeks | 
| blood-sample: triglycerides | blood-sample | 4 weeks | 
| blood-sample: high-density lipoprotein (HDL) | blood-sample | 4 weeks | 
| blood-sample: low-density lipoprotein (LDL) | blood-sample | 4 weeks | 
| blood-sample: Crea/glomerular filtration rate (GfR) | blood-sample | 4 weeks | 
| blood-sample: glutamate oxaloacetate transaminase (GOT) | blood-sample | 4 weeks | 
| blood-sample: glutamic pyruvic transaminase (GPT) | blood-sample | 4 weeks | 
| blood-sample: gamma-glutamyl transpeptidase (GGT) | blood-sample | 4 weeks | 
| blood-sample: creatine kinase (CK) | blood-sample | 4 weeks | 
| blood-sample: myoglobin | blood-sample | 4 weeks | 
| blood-sample: sodium | blood-sample | 4 weeks | 
| potassium | blood-sample | 4 weeks | 
| life quality | questionnaire: Short Form 36 Health Survey (SF-36) | 4 weeks | 
| self-efficacy | questionnaire: Allgemeine Selbstwirksamkeit Kurzskala (ASKU) | 4 weeks | 
| activities of daily living | questionnaire: Late-Life Function & Disability Instrument (LLFDI) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WB-EMS, rehabilitation, sarcopenia