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Whole-body Electromyostimulation in Inpatient Rehabilitation (GERKO)

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
WB-EMS
(synchronized) Training program without WB-EMS
Sponsored by
Prof. Dr. Frank Mooren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring WB-EMS, rehabilitation, sarcopenia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik Königsfeld der DRV

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

WB-EMS

partial WB-EMS

control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

(isometric) muscle strength of arms, legs and trunk (extenstion)
isometric strength [Nm] (DIERs Myoline professional, DIERs International GmbH)
muscle function
chair rise test [repetitions; n]
muscle function / submaximal performance test
6 minute walking test [distance; m]

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2018
Last Updated
May 12, 2021
Sponsor
Prof. Dr. Frank Mooren
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1. Study Identification

Unique Protocol Identification Number
NCT03767088
Brief Title
Whole-body Electromyostimulation in Inpatient Rehabilitation
Acronym
GERKO
Official Title
Evaluation of Whole-body Electromyostimulation (WB-EMS) in the Context of Inpatient Rehabilitation of Cardiological and Orthopedic Patients by Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Frank Mooren

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
WB-EMS, rehabilitation, sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled parallel group design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WB-EMS
Arm Type
Active Comparator
Arm Description
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
Arm Title
partial WB-EMS
Arm Type
Active Comparator
Arm Description
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
Arm Title
control
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
WB-EMS
Intervention Description
whole body electromyostimulation
Intervention Type
Other
Intervention Name(s)
(synchronized) Training program without WB-EMS
Intervention Description
20 min of pronounced eccentric movement patterns
Primary Outcome Measure Information:
Title
(isometric) muscle strength of arms, legs and trunk (extenstion)
Description
isometric strength [Nm] (DIERs Myoline professional, DIERs International GmbH)
Time Frame
4 weeks
Title
muscle function
Description
chair rise test [repetitions; n]
Time Frame
4 weeks
Title
muscle function / submaximal performance test
Description
6 minute walking test [distance; m]
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
muscle mass via multifrequency bioimpedance analysis
Description
via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)
Time Frame
4 weeks
Title
body fat via multifrequency bioimpedance analysis
Description
via multifrequency bioimpedance analysis (BIA, Inbody770, Seoul, Korea)
Time Frame
4 weeks
Title
blood-sample: triglycerides
Description
blood-sample
Time Frame
4 weeks
Title
blood-sample: high-density lipoprotein (HDL)
Description
blood-sample
Time Frame
4 weeks
Title
blood-sample: low-density lipoprotein (LDL)
Description
blood-sample
Time Frame
4 weeks
Title
blood-sample: Crea/glomerular filtration rate (GfR)
Description
blood-sample
Time Frame
4 weeks
Title
blood-sample: glutamate oxaloacetate transaminase (GOT)
Description
blood-sample
Time Frame
4 weeks
Title
blood-sample: glutamic pyruvic transaminase (GPT)
Description
blood-sample
Time Frame
4 weeks
Title
blood-sample: gamma-glutamyl transpeptidase (GGT)
Description
blood-sample
Time Frame
4 weeks
Title
blood-sample: creatine kinase (CK)
Description
blood-sample
Time Frame
4 weeks
Title
blood-sample: myoglobin
Description
blood-sample
Time Frame
4 weeks
Title
blood-sample: sodium
Description
blood-sample
Time Frame
4 weeks
Title
potassium
Description
blood-sample
Time Frame
4 weeks
Title
life quality
Description
questionnaire: Short Form 36 Health Survey (SF-36)
Time Frame
4 weeks
Title
self-efficacy
Description
questionnaire: Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
Time Frame
4 weeks
Title
activities of daily living
Description
questionnaire: Late-Life Function & Disability Instrument (LLFDI)
Time Frame
4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank C Mooren, Prof
Organizational Affiliation
Department of Rehabilitation Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik Königsfeld der DRV
City
Ennepetal
State/Province
NRW
ZIP/Postal Code
58256
Country
Germany

12. IPD Sharing Statement

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Whole-body Electromyostimulation in Inpatient Rehabilitation

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