Whole-body Electromyostimulation in Inpatient Rehabilitation (GERKO)

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Device: WB-EMS; Other: (synchronized) Training program without WB-EMS

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

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Ennepetal, NRW, Germany, 58256
      • Klinik Königsfeld der DRV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: WB-EMS; 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; whole body electromyostimulation
Active Comparator: partial WB-EMS; 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; whole body electromyostimulation
Sham Comparator: control; 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; 20 min of pronounced eccentric movement patterns

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prof. Dr. Frank Mooren
• Investigators: Principal Investigator: Frank C Mooren, Prof, Department of Rehabilitation Science

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; sarcopenia; WB-EMS
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: UWittenHerdecke

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No