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Completed

NCT Number: NCT03767088

Whole-body Electromyostimulation in Inpatient Rehabilitation

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Königsfeld der DRV

Ennepetal, North Rhine-Westphalia, 58256, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WB-EMS

Device

whole body electromyostimulation

(synchronized) Training program without WB-EMS

Other

20 min of pronounced eccentric movement patterns

Primary outcomes

  1. (isometric) muscle strength of arms, legs and trunk (extenstion)

    Time frame: 4 weeks

    isometric strength [Nm] (DIERs Myoline professional, DIERs International GmbH)

  2. muscle function

    Time frame: 4 weeks

    chair rise test [repetitions; n]

  3. muscle function / submaximal performance test

    Time frame: 4 weeks

    6 minute walking test [distance; m]

Secondary outcomes

  1. muscle mass via multifrequency bioimpedance analysis

    Time frame: 4 weeks

    via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)

  2. body fat via multifrequency bioimpedance analysis

    Time frame: 4 weeks

    via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)

  3. blood-sample: triglycerides

    Time frame: 4 weeks

    blood-sample

  4. blood-sample: high-density lipoprotein (HDL)

    Time frame: 4 weeks

    blood-sample

  5. blood-sample: low-density lipoprotein (LDL)

    Time frame: 4 weeks

    blood-sample

  6. blood-sample: Crea/glomerular filtration rate (GfR)

    Time frame: 4 weeks

    blood-sample

  7. blood-sample: glutamate oxaloacetate transaminase (GOT)

    Time frame: 4 weeks

    blood-sample

  8. blood-sample: glutamic pyruvic transaminase (GPT)

    Time frame: 4 weeks

    blood-sample

  9. blood-sample: gamma-glutamyl transpeptidase (GGT)

    Time frame: 4 weeks

    blood-sample

  10. blood-sample: creatine kinase (CK)

    Time frame: 4 weeks

    blood-sample

  11. blood-sample: myoglobin

    Time frame: 4 weeks

    blood-sample

  12. blood-sample: sodium

    Time frame: 4 weeks

    blood-sample

  13. potassium

    Time frame: 4 weeks

    blood-sample

  14. life quality

    Time frame: 4 weeks

    questionnaire: Short Form 36 Health Survey (SF-36)

  15. self-efficacy

    Time frame: 4 weeks

    questionnaire: Allgemeine Selbstwirksamkeit Kurzskala (ASKU)

  16. activities of daily living

    Time frame: 4 weeks

    questionnaire: Late-Life Function & Disability Instrument (LLFDI)

Sponsors and collaborators

Lead sponsor

Prof. Dr. Frank Mooren

Other

Registry information

Official study title

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

Acronym: GERKO

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 6, 2018
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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